Company

Ticker

Price

MktCp(M)

Cat-Date

Category

Product

Catalyst Summary

Update

Aastrom Biosciences ASTM

$2.49

$96

In JUL 2011, announced SPA agmt w/ FDA for design of pending pivotal P3 trial for pts Ixmyelocel-T w/ no-option critical limb (bone ischemia (CLI) that is Pending Pivotal marrow, expected to begin during Phase 3 patient4Q11, final 12-month results (REVIVE-CLI) derived cell from Phase 2b RESTORE-CLI Clinical Trial therapy study will be presented at AHA 11/14/11 under SPA product) mtg on 11/14/11 8/16/11 Completed pt enrlmt (21) in DEC 2010 for treatment of Ixmyelocel-T severe heart failure (dilated (bone cardiomyopathy or DCM) via marrow, direct catheter injection and patientexpects to report six-month IMPACT-DCM derived cell results during 3Q11, Catheter Phase therapy ClinicalTrials.gov ID 2 Clinical Trial product) NCT01020968

Aastrom Biosciences ASTM

$2.49

$96

9/30/11

8/16/11

Aastrom Biosciences ASTM

$2.49

$96

9/19/11

IMPACT-DCM Surgical Phase 2 Clinical Trial

In JAN 2011, reported sixmonth interim results for pts w/ dilated cardiomyopathy (DCM) w/ no safety concerns and Ixmyelocel-T positive trends in quality of life (bone and functional parameters in treatment group, will present marrow, final 12-month results at heart patientderived cell failure society mtg on 9/19/11, ClinicalTrials.gov ID therapy NCT00765518 8/16/11 product) In OCT 2010, regained all rights to drug w/ ongoing P3 trial that is expected to enroll 170 pts w/ Parkinsons disease psychosis, ClinicalTrials.gov ID NCT01174004 w/ results expected during 3Q12

ACADIA Pharma

ACAD

$1.31

$69

9/30/12

Pimavanserin (once-daily oral tablet) (5-HT2A receptor Phase 3 Clinical inverse Trial agonist)

6/16/11

AcelRx Pharma

ACRX

$3.20

$62

ARX-01 (Sufentanil Pending Pivotal NanoTab Phase 3 Clinical PCA 12/31/11 Trials System)

On 6/30/11, obtained $20M secured loan agmt to fund three planned P3 trials for ARX-01, expects to begin enrolling pts in first P3 trial (post-op pain after abdominal surgery) during 2H11 and begin enrolling pts in a second P3 trial vs. standard of care (IV PCA morphine) in early 2012 (1Q12 estimate) 7/5/11

Achillion Pharma

ACHN

$5.46

$381

ACH-2684 (pangenotypic HCV Phase I Clinical protease 12/31/11 Trial inhibitor)

On 5/25/11, began dosing in trial to assess safety and antiviral activity of drug being developed for chronic hepatitis C virus (HCV) infection, expects to enroll up to 78 healthy volunteers and 40 HCV pts, expects report proofof-concept data by year-end 2011 5/25/11 On 7/12/11, began dosing subjects in P1 trial for compound being developed for treatment of chronic hepatitis C virus (HCV) infection, expects to enroll 48 healthy volunteers and 20 HCV pts, estimated results during 1Q12

Achillion Pharma

ACHN

$5.46

$381

3/31/12

ACH-2928 Phase I Clinical (NS5A Trial inhibitor)

7/12/11

Achillion Pharma

ACHN

$5.46

$381

Phase 2a 12/31/11 Clinical Trial

In MAR 2011, reported topline results for once-daily dosing in combo w/ standard of care treatment for chronic hepatitis C (HCV) infection w/ 75-81% of pts achieving rapid ACH-1625, virologic response, expects to a hepatitis C begin 12-week segment of trial virus (HCV) during 2Q11 and report viral protease response (12-week EVR) data inhibitor by year-end 2011 5/25/11 As of 8/1/11, 140 of 150 pts enrolled in ongoing P2 trial in combo w/ COPAXONE for Relapsing Remitting Multiple Sclerosis (RRMS), expects to complete enrlmt by yr-end 2011, ClinicalTrials.gov ID NCT00451204 w/ results expected during 2H13

Adeona Pharma

AEN

$0.62

$17

Phase 2 Clinical Trimesta 12/31/13 Trial (estriol)

8/15/11

Advanced Cell Technology ACTC

$0.16

$256

9/30/13

Phase I/II Clinical Trial

In JUL 2011, began dosing pts in each of two P1/2 trials for eye conditions (Stargardt's Macular Dystrophy or SMD and Dry Age-Related Macular Degeneration or Dry AMD), plans to enroll 12 pts in each trial w/ 12-month primary Retinal endpts, ClinicalTrials.gov IDs Pigment NCT01345006 and Epithelial NCT01344993 w/ results for (RPE) Cells both trials expected 3Q13

7/15/11

Advaxis

ADXS

$0.14

$33

3/31/12

On 7/25/11, announced revised protocol in ongoing ADXS11cervical dysplasia (a pre001 (live, cancerous condition aka CIN) attenuated P2 trial expected to accelerate Listeria enrlmt by up to 5 months in monocytoge mid-dose group, expects to nes or Lm- report low-dose trial results in based early 2012 (1Q12 estimate), Phase 2 Clinical immunoClinicalTrials.gov ID Trial therapy) NCT01116245 7/25/11

Aegerion Pharma

AEGR

$14.50

$305

Lomitapide (AEGR-733) (Microsomal Triglyceride FDA New Filing Transfer (NDA), MAA / Protein or EMA (Europe) MTP 12/31/11 New Filing Inhibitor)

Expects to file NDA and MAA / EMA by yr-end 2011 based on 56-week data from pivotal P3 trial for treatment of genetic disorder resulting in very high cholesterol levels (HoFH), expects to submit full 78-week data as supplement to support regulatory approval filings 8/17/11

Aeterna Zentaris

AEZS

$1.90

$184

On 8/30/11, announced pivotal P3 trial under SPA for oral diagnostic test for adult AEZS-130 growth hormone deficiency (orally active met primary endpt, preparing growth for pre-NDA mtg w/ FDA hormone followed by expected NDA FDA New Filing stimulating filing (late 2011-early 2012 12/31/11 (NDA) agent) estimate)

8/30/11

Aeterna Zentaris

AEZS

$1.90

$184

On 8/31/11, North American licensee KERX announced indpt data safety monitrg bd completed interim analysis and recmd trial continue as planned for ongoing pivotal P3 trial in pts w/ metastatic Perifosine (KRX-0401) colorectal cancer, FDA Fast (PI3K/Akt Track status, ClinicalTrials.gov ID Pivotal Phase 3 pathway (X-PECT) inhibitor anti- NCT01097018 w/ results expected by late 2011-early Clinical Trial cancer 2012 8/31/11 12/31/11 under SPA agent)

Aeterna Zentaris

AEZS

$1.90

$184

In DEC 2009, North American licensee KERX began Perifosine relapsed / refractory multiple (KRX-0401) myeloma (MM) pivotal trial, (PI3K/Akt ClinicalTrials.gov ID pathway NCT01002248 w/ results Pivotal Phase 3 inhibitor anti- expected during 4Q12, FDA Clinical Trial cancer Orphan Drug and Fast Track 12/31/12 under SPA agent) status

7/8/11

Affymax

AFFY

$4.28

$152

3/27/12

FDA Decision (NDA)

On 8/11/11 announced PDUFA decision goal date of 3/27/12 under standard 10month review, seeking approval as once-monthly anemia treatment for adult pts Peginesatid w/ chronic kidney disease on e (oncedialysis, received $10M pmt monthly from partner Takeda for NDA anemia accptce and due to receive drug) $50M if approved

8/11/11

Agenus (formerly Antigenics)

AGEN

$0.49

$56

Single-arm P2 trial for recurrent brain cancer (GBM) Prophage indicates median survival of (Patient324 days and 11 pts still alive Specific (four beyond one year) w/ Therapeutic ClinicalTrials.gov ID NCT00293423 and results Cancer expected 4Q11, Vaccine) (Approved in ClinicalTrials.gov ID Russia as NCT00905060 for trial in Oncophage combo w/ TEMODAR for Phase 2 Clinical for kidney newly diagnosed glioma w/ cancer) 12/31/11 Trials results expected 1Q14

8/17/11

Alexion Pharma

ALXN

$59.48

$10,976

10/7/11

FDA Decision (sBLA) (Priority Review)

On 6/1/11, announced FDA accepted sBLA filing w/ sixmonth priority review for expected decision by 10/7/11, seeking expanded approval for for treatment of pts w/ SOLIRIS atypical Hemolytic Uremic (eculizumab Syndrome (rare blood clotting ) disorder)

6/1/11

Alexza Pharma

ALXA

$1.22

$88

2/4/12

FDA Decision (NDA)

On 8/19/11 announced FDA accepted NDA resubmission (in response to CRL issued in OCT 2010) for six-month Class 2 review w/ PDUFA decision goal date of 2/4/12, seeking aprvl for rapid ADASUVE (inhaled) treatment of agitation (Staccato in adults with schizophrenia or loxapine) bipolar disorder, expects (formerly AZ- advisory panel mtg to be 004) scheduled 8/19/11

Alimera Sciences

ALIM

$7.18

$225

ILUVIEN (fluocinolone FDA Decision intravitreal (NDA) (Class 2 insert) Resubmission), (sustained MAA / MHRA eye drug (Europe) delivery 11/12/11 Decision system)

In MAY 2011, announced NDA resubmission in response to DEC 2010 CRL, seeking approval for diabetic macular edema w/ PDUFA decision goal date of 11/12/11 under six-month Class 2 review and no advisory panel mtg to be held, MAA filed for EU approval in JUL 2010 w/ MHRA (UK) and expected decision during 1Q12, licensed from PSDV 8/31/11

Alkermes

ALKS

$16.43

$1,610

Phase 2 Clinical ALKS 33 Trial, Phase I / II (oral opioid 12/31/11 Clinical Trial modulator) ALKS 37 (orally active peripheral Phase 2 Clinical opioid Trial antagonist) ALKS 5461 (oral combo of ALKS 33 + buprenorphi ne)

On 7/7/11, announced P2 trial for binge eating disorder failed to meet endpt, ClinicalTrials.gov ID NCT01366001 for P1/2 trial for cocaine abuse w/ results expected mid-2012, ClinicalTrials.gov ID NCT01381107 for P1/2 trial in combo w/ buprenorphine (ALKS 5461) for depression w/ results expected 2H11 ClinicalTrials.gov ID NCT01382797 w/ results expected mid-2012 for P2 trial in up to 150 adults with opioidinduced constipation (OIC) On 6/15/11, began trial for refractory depression not controlled by std therapy, expects to enroll 32 pts and report top-line results 2H11

7/7/11

Alkermes

ALKS

$16.43

$1,610

6/30/12

7/7/11

Alkermes

ALKS

$16.43

$1,610

Phase I / II 12/31/11 Clinical Trial

6/15/11

Alkermes

ALKS

$16.43

$1,610

ALKS 9070 (oncemonthly injected prodrug formulation Pending Pivotal that converts Phase 3 Clinical to aripiprazole) 12/31/11 Trial

On 6/30/11 announced positive results in P1B trail for pts w/ schizophrenia and expects to begin pivotal clinical program by year-end 2011, is a novel once-monthly formulation of approved drug ABILIFY

6/30/11

Allon Therapeutic s (NPCUF.PK ) NPC.TO

$0.37

$29

As of 8/12/11, has enrolled approx. 75% of pts in ongoing pivotal trial for treatment of progressive degenerative Davunetide brain disease (progressive (derived supranuclear palsy), expects from neuro- to complete enrlmt by yr-end protective 2011and report data about Pivotal Phase brain one year later (4Q12 estimate) 2b / 3 Clinical protein, ClinicalTrials.gov ID 12/31/12 Trial under SPA ADNP) NCT01110720 8/23/11

Alnylam

ALNY

$6.37

$272

ALN-TTR01 (systemic RNA interference or RNAi therapeutic Phase I Clinical for 11/20/11 Trial amyloidosis) ALN-PCS (RNAi therapeutic for the treatment of severe elevated Phase I Clinical cholesterol 12/31/11 Trial levels)

In JUL 2010 began dosing in P1 trial, will enroll up to 28 pts w/ amyloidosis (condition that damages peripheral nerves and heart), expects to present data at scientific mtg Nov. 2022 in Japan, developed using TKMR RNAi delivery tech

8/2/11

Alnylam

ALNY

$6.37

$272

On 7/11/11, announced filing of CTA for clearance to conduct P1 trial in UK in 32 healthy volunteers and expects to present initial safety / activity data by year-end 2011 7/11/11

Alnylam

ALNY

$6.37

$272

Phase 2b 12/31/12 Clinical Trial

ClinicalTrials.gov ID NCT01065935 for ongoing P2B trial in combo with standard of care in ALN-RSV01 Respiratory Syncytial Virus (inhaled (RSV) infected adult lung treatment, transplant patients, results given by expected during 4Q12, nebulizer) partnered w/ CBST

8/2/11

Amarin

AMRN

$10.71

$1,426

9/30/11

Expects to file NDA by end of SEP 2011 seeking approval for treatment of pts w/ very high triglycerides (>=500 mg/dl) w/ addtl data from P3 AMR101 trials to be presented at AHA FDA New Filing (icosapent mtg Nov 15-16, on 8/10/11 (NDA), Pending ethyl) reported SPA agmt w/ FDA for Cardiovascular Prescription long-term (six-year) study in Outcomes Study Grade 8,000 pts expected to begin in (REDUCE-IT) Omega-3 2011 w/ target of 50% enrolled under SPA Fatty Acid) by yr-end 2012 8/10/11

Amgen

AMGN

$54.44

$50,308

4/26/12

FDA Decision (sBLA)

On 8/22/11, announced PDUFA action goal date of 4/26/12 for expected FDA decision seeking expanded approval to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases, currently approved for XGEVA prevention of skeletal-related (denosumab events in pts w/ cancer that ) has spread to bones

8/22/11

Amgen

AMGN

$54.44

$50,308

Ongoing pivotal P3 trial in pts OncoVEX w/ malignant melanoma (skin GM-CSF cancer) fully enrolled w/ (therapeutic results expected during 2H11, Pivotal Phase 3 cancer ClinicalTrials.gov ID 12/31/11 Clinical Trial vaccine) NCT00769704 Expects to complete pt enrlmt in ongoing P3 (Study 011) trial 4Q11, treat first pt in P3 AMIGAL (migalastat (Study 012) trial 3Q11, and HCl) for the report prelim results in P2 Treatment of (Study 013) trial in combo w/ enzyme replcmt therapy Fabry 4Q11, partnered w/ GSK Disease

7/29/11

Amicus Therapeutic s FOLD

$3.93

$136

Phase II and III 12/31/11 Clinical Trials

8/9/11

Amylin Pharma

AMLN

$10.65

$1,554

FDA Decision 10/22/11 (sNDA)

BYETTA (exenatide)

On 12/22/10, announced submission of sNDA, seeking FDA approval for expanded use as add-on therapy to basal insulin for adult type 2 diabetics not achieving adequate blood sugar control, estimated FDA decision by 10/22/11 under a standard 10month review period, partnered w/ LLY 12/22/10

Amylin Pharma

AMLN

$10.65

$1,554

Metreleptin (recombinant methionyl FDA New Filing human 12/31/11 (BLA) leptin)

In JUN 2011 reported results of treatment IND study w/ improved diabetes and lipid control in pts w/ lipodystrophy, FDA Orphan Drug and Fast Track status, expects to submit final portion of rolling BLA filing for chemistry, manufacturing, and controls (CMC) section by year-end 2011 6/20/11

Amylin Pharma

AMLN

$10.65

$1,554

1/28/12

FDA Decision (NDA)

On 8/10/11 reported PDUFA decision goal date of 1/28/12 under six-month Class 2 NDA resubmission, seeking BYDUREON approval as once-weekly (exenatide treatment for type 2 diabetes, extendedin JUN 2011 received release approval in Europe, partnered injectable w/ LLY and ALKS receives suspension) drug delivery royalties

8/10/11

Anacor Pharma

ANAC

$4.82

$136

In MAY 2011, dosed first pt in P2 trial to evaluate both compounds compared to their AN2728 and ointment vehicles (no drug AN2898 included) for treatment of mild(boronto-moderate atopic dermatitis Phase 2 Clinical based PDE- w/ results expected during 12/31/11 Trial 4 inhibitors) 2H11 8/12/11 In JUN 2011, partner GSK began two P2B trials for treatment of complicated urinary tract infections (cUTI) GSK 052 and complicated intra(GSK22510 abdominal infections (cIAI), 52, formerly ClinicalTrial.gov IDs AN3365) NCT01381562 and (systemic NCT01381549 w/ results antibiotic) expected during 1H12

Anacor Pharma

ANAC

$4.82

$136

6/30/12

Phase 2b Clinical Trials

8/12/11

Anacor Pharma

ANAC

$4.82

$136

Expects to complete enrlmt in two ongoing P3 trials during 2H11 w/ results expected during 2H12, being evaluated for treatment of fungal AN2690 infections of the nail and nail (topical anti- bed (onychomycosis), Pivotal Phase 3 fungal ClinicalTrials.gov ID 12/31/12 Clinical Trials product) NCT01270971 Expects to begin P2A trial in Europe during 3Q11 and complete dosing in first cohort 4Q11 in combo w/ / ribavirin for treatment of hepatitis C virus (HCV) infection

8/12/11

Anadys Pharma

ANDS

$0.67

$38

Phase 2a 12/31/11 Clinical Trial

ANA773 (oral TLR7 interferon inducer)

8/12/11

Anadys Pharma

ANDS

$0.67

$38

Phase 2b 10/31/11 Clinical Trial

In JUL 2011, completed pt enrlmt in ongoing P2B trial in combo w/ PEG-interferon and ribavirin for chronic hepatitis C virus (HCV) infection, expects Setrobuvir all pts to complete 12-wk visit (ANA598) by end 3Q11 w/ prelim 12-wk (NonNucleoside data shortly after (OCT 2011 estimate) w/ 24-wk anti-viral HCV Polymerase data expected around yr-end 2011 8/12/11 Inhibitor)

Anika Therapeutic s ANIK

$5.88

$80

FDA Decision 12/31/11 510(k)

Hyaloglide (healing aid gel for tendon and nerve surgeries)

As of AUG 2011, reported disagreement w/ FDA which is leaning toward the PMA route for review, estimate for 2H11 update on status As of AUG 2011, provided guidance to receive FDA 510(k) marketing clearance by yr-end 2011, submission currently being reviewed by FDA biologics division, product includes patientderived bone marrow stem cell component

8/8/11

Anika Therapeutic s ANIK

$5.88

$80

FDA Decision 12/31/11 510(k)

Hyalofast (cartilage generation product)

8/8/11

Anika Therapeutic s ANIK

$5.88

$80

FDA Decision 12/31/11 510(k)

Hyalonect (bone wrap mesh for repair of fractures)

As of AUG 2011, provided guidance to receive FDA 510(k) marketing clearance w/in next couple of months (2H11 estimate)

8/8/11

Anika Therapeutic s ANIK

$5.88

$80

FDA Decision (PMA Medical Device) or Potential FDA Advisory Panel 12/31/11 Meeting

In AUG 2011, announced 2Q results and still awaiting FDA response on pending PMA (2H11 estimate for either Monovisc decision or possible advisory (singlepanel mtg being scheduled) injection, six- following late APR 2011 mtg month bio- w/ FDA, no safety issues and polymer discussing efficacy results, arthritis PMA originally filed in DEC product) 2009

8/8/11

Antares Pharma

AIS

$2.24

$231

12/8/11

FDA Decision (NDA)

On 7/11/11, announced exclusive licensing agmt w/ WPI including regulatory approval and sales-based milestone pmts plus escalating royalties on US and ANTUROL Canada product sales w/ (transdermal PDUFA decision goal date of oxybutynin 12/8/11 under a standard 10ATD gel) month review 7/11/11

Anthera Pharma

ANTH

$4.61

$188

3/31/12

Ongoing pivotal P3 trial in high-risk acute coronary syndrome pts on track to A-002 accrue 385 primary endpoint (varespladib events 1Q12, DSMB met in early JUL 2011 (fourth time) methyl) Pivotal Phase 3 (once-daily, and recommended trial (VISTA-16) oral inhibitor continue as planned w/ DSMB Clinical Trial of sPLA2 efficacy data statistical review under SPA enzyme) expected 2H11

8/1/11

Anthera Pharma

ANTH

$4.61

$188

Phase 2b (PEARL-SC) 12/31/11 Clinical Trial

As of 6/30/11, pt enrlmt exceeded 50% w/ last pt on track to be randomized during 4Q11, during 2Q11 DSMB recommended trial continue as planned w/ no safety A-623 (Sub- concerns, ClinicalTrials.gov ID cutaneous NCT01162681 for P2B trial in lupus pts w/ results expected Dual Inhibitor of during 1H12, decision expected 2H11 on potential pt BAFF or enrlmt expansion BLyS)

8/1/11

Apricus Biosciences APRI

$4.49

$89

3/31/12

MAA / EMA (Europe), Switzerland Decisions

In JUL 2011, announced Swiss MAA filing and in JUN 2011 reported MAA accepted for rvw in Europe (estimated decisions during 1Q12), approved by Health Canada as topical treatment for erectile dysfunction (ED) in NOV VITAROS 2010, in AUG 2011 reported (alprostadil plans to file for aprvl in Latin America w/ first filing expected topical 8/11/11 formulation) w/in 8-10 wks

Ardea Biosciences RDEA

$15.30

$410

9/30/11

Pending Phase 3 Clinical Trials

Lesinurad (formerly RDEA594) (a selective URAT1 transporter inhibitor for treatmentresistant gout)

In JAN 2011, reported positive top-line results in Phase 2b study in combo w/ allopurinol for treatment-resistant gout w/ addtl open-label results presented in MAY 2011, expects to report results of FDA end-of-P2 mtg during 3Q11 to support planned pivotal P3 trials 8/17/11

Arena Pharma

ARNA

$1.26

$184

In AUG 2011, reported lower brain concentration of drug in humans vs. rats and readjudication of female rat mammary tumor diagnoses, expects to submit MAA for EU approval in 2012 and FDA Lorcaserin response to OCT 2010 by yrResubmission to (a selective end 2011 to address nonComplete serotonin 2C clinical trial issues cited by Response Letter receptor FDA such as brain tumors in 12/31/11 (CRL) agonist) rats, partnered w/ Eisai

8/9/11

Ariad Pharma

ARIA

$9.41

$1,247

In AUG 2011 EMA completed admin validation process for MAA seeking EU approval for metastatic soft-tissue or bone FDA Reply to sarcomas, submitted by Accept NDA and Ridaforolimu partner MRK in JUL 2011 w/ Issue PDUFA s (mTOR estimated decision 1Q12, Date (mid-Oct), inhibitor, expected FDA reply w/in 60 MAA / EMA oral antidays (mid-OCT 2011) to (Europe) cancer accept NDA filing and issue PDUFA decision goal date 10/17/11 Decision (1Q12) agent)

8/18/11

Ariad Pharma

ARIA

$9.41

$1,247

On 8/2/11, reported pt enrlmt expected to close during 3Q11 (six months ahd of schedule) in ongoing pivotal P2 trial in Ponatinib (AP24534) pts w/ blood-based cancers (pan-BCR- CML and Ph+ ALL, has ABL inhibitor submitted to present interim anti-cancer data at ASH mtg Dec 10-13, Pivotal Phase 2 agent) (once- expects to file NDA in mid(PACE) Clinical daily 45 mg 2012 w/ six-month priority rvw request tablet) 12/10/11 Trial

8/2/11

ArQule

ARQL

$4.13

$222

6/30/12

Ongoing P2 trials for primary liver cancer (HCC) (ClinicalTrials.gov ID NCT00988741 w/ results 1H12), in combo w/ ERBITUX Tivantinib + irinotecan for colorectal (ARQ 197) cancer (NCT01075048 w/ (c-Met results 1Q13), in combo w/ inhibitor anti- TARCEVA for lung cancer Phase 2 Clinical cancer (NCT01395758 w/ mid-2012 Trials agent) results)

7/21/11

ArQule

ARQL

$4.13

$222

6/30/13

In NOV 2010, began pivotal P3 trial in combo w/ TARCEVA for non-small cell Tivantinib lung cancer (NSCLC) that is (ARQ 197) expected to enroll 1,000 pts, partnered with Daiichi Sankyo, (c-Met Pivotal Phase 3 inhibitor anti- ClinicalTrials.gov ID NCT01244191 w/ results Clinical Trial cancer expected mid-2013 7/21/11 under SPA agent)

Array BioPharma

ARRY

$2.13

$121

Ongoing P2 single-agent trial for multiple myeloma (MM) (ClinicalTrials.gov ID NCT00821249) w/ results ARRY-520 expected by yr-end 2011, P1B (KSP combo trial w/ VELCADE for inhibitor anti- MM (ClinicalTrials.gov ID Phase 2 Clinical cancer NCT01248923) w/ results 12/31/11 Trials agent) expected during 1Q13

8/9/11

Array BioPharma

ARRY

$2.13

$121

3/31/12

ARRY-797 Phase 2 Clinical (p38 Trial inhibitor) MEK162 (ARRY-162) (MEK inhibitor antiPhase 2 Clinical cancer Trial agent)

Being evaluated in P2 trial w/ 150 pts for treatment of chronic pain in pts w/ osteoarthritis, expects to report top-line results during 1Q12, being compared to OxyContin and placebo for moderate to severe pain while pts continue taking NSAID drugs 8/9/11 In APR 2011, achieved $10M milestone pmt from partner NVS for start of P2 trial in pts w/ melanoma, ClinicalTrials.gov ID NCT01320085 w/ results expected during 1H13 Expects to complete enrlmt during 3Q11 and report topline results by yr-end 2011 in healthy volunteers to support planned P2A trial in pts w/ persistent asthma

Array BioPharma

ARRY

$2.13

$121

6/30/13

7/7/11

Array BioPharma

ARRY

$2.13

$121

ARRY-502 (CRTh2 antagonist for allergic Phase I Clinical inflammation 12/31/11 Trial )

8/9/11

Array BioPharma

ARRY

$2.13

$121

Phase 1b 12/31/11 Clinical Trial

ARRY-614 (p38/Tie2 inhibitor anticancer agent)

Expects to report top-line results by yr-end 2011 for Myelodysplastic Syndrome (MDS), ClinicalTrials.gov ID NCT00916227

8/9/11

Array BioPharma

ARRY

$2.13

$121

Ongoing P2 trials include ClinicalTrials.gov IDs NCT01116271 for colon cancer w/ data expected Selumetinib during 1Q12, NCT00890825 (AZD6244) for non-small cell lung cancer (MEK (NSCLC) w/ data expected inhibitor anti- 2H11, and NCT00936221 for Phase 2 Clinical cancer melanoma w/ results expected 12/31/11 Trials agent) 2H11, partnered w/ AZN

7/7/11

AspenBio Pharma

APPY

$3.49

$28

9/30/11

On 7/19/11, announced expected pre-pivotal trial interim results during 3Q11, AppyScore also submitted pre-IDE (bloodpackage to FDA and plans to Pre-Pivotal based meet to discuss clinical / Clinical Trial diagnostic regulatory pathway including (Medical Device screening design of planned pivotal trial / Diagnostic test for based on the mtg and preappendicitis) pivotal trial results Test)

7/19/11

Astex Pharma (formerly SuperGen)

SUPG

$2.07

$192

3/6/12

FDA Decision (sNDA)

In JUL 2011, partner Eisai announced FDA accepted sNDA for review w/ expected decision by 3/6/12 under DACOGEN standard 10-month rvw, (decitabine) seeking expanded approval (currently for acute myeloid leukemia approved for (AML) based on P3 (DACOpts w/ 016) trial w/ non-stat sig 2.7 myelodyspla month increase in survival, EU partner JNJ expected to file for stic syndromes approval in Europe by yearend 2011 7/20/11 or MDS)

Astex Pharma (formerly SuperGen)

SUPG

$2.07

$192

Amuvatinib (MP-470) (oral tyrosine kinase inhibitor or multi-TKI Phase 2 Clinical anti-cancer 12/31/12 Trial agent)

ClinicalTrials.gov ID NCT01357395 w/ results expected during 4Q12 for open-label P2 trial in combo w/ platinum-etoposide chemotherapy in pts w/ small cell lung cancer (SCLC) who have not responded or relapsed to standard therapy, Astex merger closed in JUL 2011 w/ new ticker ASTX to be effective during 3Q11 7/20/11

Athersys

ATHX

$1.95

$46

On 3/14/11, began enrolling pts for treatment of ulcerative colitis, partnered with PFE for this indication, expects to enroll up to 126 pts w/ primary MultiStem safety and efficacy endpts (Adult evaluated after 8 weeks w/ a Progenitor 12-month follow-up period, or MAPC ClinicalTrials.gov ID Phase 2 Clinical Stem Cell NCT01240915 w/ results 12/31/12 Trial Technology) expected during 2H12 8/26/11 In MAY 2011, announced positive interim results in ongoing P1 trial for prevention of graft vs. host disease (GvHD), ClinicalTrials.gov ID NCT00677859 and final results expected 2H11 8/17/11

Athersys

ATHX

$1.95

$46

MultiStem (Adult Progenitor or MAPC Phase I Clinical Stem Cell 12/31/11 Trial Technology)

Auxilium Pharma

AUXL

$15.52

$744

6/30/12

During 3Q11 completed dosing of pts in ongoing P3 trial for treatment of Peyronie's disease w/ top-line data expected during 2Q12 to support potential sNDA filing (current approved for XIAFLEX treatment of adult Dupuytren's (collagcontracture), ClinicalTrials.gov Pivotal Phase 3 enase ID NCT01243411, BSTC (IMPRESS) clostridium receives royalties on sale of Clinical Trials histolyticum) drug In AUG 2010, completed pt enrlmt in ongoing pivotal P3 trial compared to NEXAVAR for pts w/ advanced kidney (renal) cancer, ClinicalTrials.gov ID NCT01030783 w/ results expected during 4Q11 at the earliest, partnered w/ Astellas

9/2/11

AVEO Pharma

AVEO

$15.55

$670

Tivozanib (AV-951) (oral, oncedaily vascular endothelial Pivotal Phase 3 growth factor (TIVO-1) Clinical or VEGF 12/31/11 Trial inhibitor)

7/29/11

AVEO Pharma

AVEO

$15.55

$670

6/30/12

Phase 1b / 2 Clinical Trial

Ficlatuzuma b (AV-299) (antihepatocyte growth factor or HGF antibody)

Has completed pt enrlmt in P2 portion of ongoing P1B/2 trial in combo w/ IRESSA as firstline treatment for pts w/ nonsmall cell lung cancer (NSCLC), ClinicalTrials.gov ID NCT01039948 w/ results expected during 2Q12 7/29/11 On 6/22/11, began dosing healthy subjects in P1 trial, being developed for treatment of influenza (flu infection), ClinicalTrials.gov ID NCT01375985 w/ results expected during 1Q12 On 8/17/11, began dosing pts in P2 trial for treatment of Duchenne muscular dystrophy w/ results expected around end 2Q12 to support planned pivotal P3 trial during 2H12, ClinicalTrials.gov ID NCT01396239 In DEC 2010, began enrolling in 250-patient trial as an addon therapy in gout patients who have not responded to allopurinol therapy alone, expects to complete the P2b trial in late 2011 (4Q11 estimate)

AVI BioPharma

AVII

$1.07

$145

3/31/12

AVI-7100 (broad spectrum influenza Phase I Clinical drug Trial candidate)

6/22/11

AVI BioPharma

AVII

$1.07

$145

6/30/12

Eteplirsen (AVI-4658) (exon Phase 2 Clinical skipping Trial therapy)

8/17/11

BioCryst Pharma

BCRX

$2.85

$128

Phase 2b 12/31/11 Clinical Trial

BCX4208 (oral purine nucleoside phosphorylase inhibitor)

6/16/11

BioCryst Pharma

BCRX

$2.85

$128

6/30/13

Clinical-Trials.gov ID NCT00958776 for P3 trial of pts hospitalized w/ influenza (flu virus), results expected during 2Q13 after revising primary endpt in ongoing P3 Peramivir trial and reporting results from (IV) (antifirst P3 trial in JAN 2011 w/ no Phase 3 Clinical viral drug for safety concerns and Trial flu) reductions in flu virus levels 8/26/11

Biodel

BIOD

$1.16

$45

Phase I Clinical Trial, Pending Phase 2 Clinical 10/31/11 Trial

BIOD-105 and BIOD107 (rapidacting insulin)

On 8/4/11, reported completion of P1 testing w/ sig more rapid absorption and similar injection site tolerability to HUMALOG, ongoing P1 insulin pump study w/ top-line results expected in OCT 2011, expects to select lead ultra rapid-acting insulin for further devlmt along w/ timelines 4Q11 8/22/11 In JUN 2011, reported less restrictive modified REMS program expected to be finalized this summer (2H11 estimate for FDA reply), would offer access to broader pt population similar to competing fast-acting fentanyl pain drugs 7/18/11

BioDelivery Sciences

BDSI

$3.18

$94

FDA Decision (new "retail" REMS program) (Risk Evaluation ONSOLIS and Mitigation (BEMA 12/31/11 Strategy) Fentanyl)

BioDelivery Sciences

BDSI

$3.18

$94

On 9/6/11 reported P1 results to support novel formulation of drug combo used in SUBOXONE for treatment of opiate dependence, expects to BEMA begin pivotal bioequivalence Buprenorphi trial in DEC 2011 and report results during 1Q12 to support Pending Pivotal ne & planned 505(b)(2) NDA filing Phase 3 PK Naloxone 12/31/11 Clinical Trial 2H12 Combo

9/6/11

BioDelivery Sciences

BDSI

$3.18

$94

9/30/11

BEMA Pivotal Phase 3 BuprenClinical Trial orphine

On 7/25/11, announced last pt completed randomized portion of pivotal P3 trial for treatment of moderate to severe chronic pain and expects to report topline results in mid-late SEP 2011 to support potential 505(b)(2) NDA filing during 1H12 7/25/11

Biogen Idec BIIB

$91.77

$22,258

Pivotal Phase 3 BG-12 (CONFIRM) (dimethyl 12/31/11 Clinical Trial fumarate)

In APR 2011, reported positive top-line data from first of two pivotal trials as oral monotherapy for relapsing-remitting multiple sclerosis, expects to report P3 CONFIRM trial data during 4Q11, ClinicalTrials.gov ID NCT00451451

8/9/11

Biogen Idec BIIB

$91.77

$22,258

3/31/13

ClinicalTrials.gov ID NCT01281189 w/ results expected during 1Q13 for ongoing pivotal P3 trial in pts Pivotal Phase 3 w/ Amyotrophic Lateral (EMPOWER) Dexpramipe Sclerosis (ALS) (Lou Gehrigs Clinical Trial xole disease)

8/9/11

Biogen Idec BIIB

$91.77

$22,258

On 8/9/11, reported positive results in pivotal P2B trial for pts w/ relapsing-remitting Daclizumab multiple sclerosis (RRMS) high-yield over one yr, ongoing second process pivotal P3 trial w/ (DAC HYP) Clinicalrials.gov ID Pivotal Phase 3 (CD25NCT01064401 and results (DECIDE) binding expected during 4Q13, 12/31/13 Clinical Trial antibody) partnered w/ ABT

8/9/11

BioMarin Pharma

BMRN

$28.06

$3,138

In AUG 2010, reported prelim results with top-line results expected during 3-4Q11 to PEG-PAL support planned pivotal P3 (PEGylated study during 1-2Q12, enzyme recombinant substitution therapy for the phenyltreatment of phenyl-ketonuria alanine or (PKU) with potential to treat PHE patients whose blood PHE Phase 2 Clinical ammonia levels are not adequately 12/31/11 Trial lyase) controlled by KUVAN

8/17/11

BioMarin Pharma

BMRN

$28.06

$3,138

6/30/13

FDA Decision 510(k) Medical Device

Hand-Held Blood Phe (phenylalanine) Monitor

Expects to receive FDA 510(k) marketing clearance by mid2013 (1-3Q13 guidance) for handheld blood Phe monitor for pts w/ phenylketonuria to support medical management of the condition which is treated w/ BMRNs marketed drug KUVAN 8/17/11

BioMarin Pharma

BMRN

$28.06

$3,138

6/30/12

In JUN 2011, dosed first pt in pivotal P3 trial for treatment of Lambert-Eaton Myasthenic Amifampridi Syndrome (LEMS) to support ne (3,4potential NDA filing during Pivotal Phase 3 diaminopyri 1H12, approved in Europe in Clinical Trial dine) JAN 2010 8/17/11

BioMarin Pharma

BMRN

$28.06

$3,138

In FEB 2011, began pivotal P3 trial for treatment of lysosomal storage disorder MucopolyGALNS saccharidosis Type IVA (MPS (BMN 110 or IVA), expects to enroll 160 N-acetylsubjects w/ top-line results galactosami expected during 2H12 to support regulatory approval Pivotal Phase 3 ne 6sulfatase) filings during 4Q12-1Q13 8/17/11 12/31/12 Clinical Trial

BioMimetic Therapeutic s BMTI

$3.18

$89

9/30/11

In MAY 2011, FDA Advisory Panel voted 12-6 in support of safety, 10-8 in support efficacy, and 10-8 in support of benefit to risk profile, in JUL 2011 met w/ FDA and expects Augment follow-up letter around SEP Bone Graft 2011 to outline post-panel FDA Decision (synthetic, reqmts for PMA aprvl and will (PMA) (Medical off-the-shelf provide update on status at Device), CE bone growth that time, expected CE Mark Mark (Europe) factor decision in 2012 (1H12 Decision product) estimate)

8/5/11

BioMimetic Therapeutic s BMTI

$3.18

$89

6/30/12

Pivotal Clinical Trial to Support PMA (Medical Augment Device) FDA Injectable Filing Bone Graft

In APR 2011, began enrolling pts in pivotal trial for hindfoot fusion indications, expects to complete enrlmt phase of trial in mid-2012, plans to submit PMA based on final 12-month safety and efficacy data

8/5/11

Bionovo

BNVI

$0.67

$37

On 8/30/11, announced successful completion of tolerability trial and dosing strategy for pending pivotal P3 trial expected to begin in fall (OCT 2011 estimate) for treatment of hot flashes, MENERBA expects 5 data safety (a selective monitoring board rvws (first 4Q11) over course of trial, estrogen expects to complete pt enrlmt Pending Pivotal receptor Phase 3 Clinical modulator or 2Q12 and report top-line data 4Q12 8/30/11 10/31/11 Trial SERM)

BioSante Pharma

BPAX

$2.51

$276

Melanoma Pending Phase I Cancer 12/31/11 Clinical Trial Vaccine

On 7/21/11, announced exclusive license agmt w/ John P. Hussman Foundation including $100,000 upfront and $39M in potential milestone pmts and royalties, expects to begin P1 trial w/in several months (2H11 estimate), Foundation will fund P2 trial if P1 trial is successful 7/21/11

BioSante Pharma

BPAX

$2.51

$276

FDA Decision 11/14/11 (NDA)

Licensed to TEVA w/ PDUFA action goal date of 11/14/11 for the treatment of low testosterone levels in males (hypogonadism), would Bio-T-Gel receive milestone payments (testosteron and royalties from TEVA if e gel) approved

4/13/11

BioSante Pharma

BPAX

$2.51

$276

On 5/31/11, completed enlrmt in P3 safety trial which continued as planned after sixth DMC safety rvw w/ results expected during 3Q12 after 12-month follow-up on last pt dosed to support potential NDA filing by yearLibiGel end 2012, expects to report Pivotal Phase 3 (testosteron data from two P3 efficacy trials 12/31/11 Clinical Trials e gel) under SPA during 4Q11 5/31/11

Cardiome Pharma

CRME

$3.53

$216

In JUL 2011, announced transfer of rts from Astellas to MRK w/ ongoing P3 trial for pts w/ abnormal heart rhythm atrial fibrillation, ClinicalTrials.gov ID NCT01174160 w/ results Vernakalant expected during 4Q12, in SEP 2010 approved in Europe, (IV Phase 3 Clinical formulation) also being developed in oral 7/27/11 12/31/12 Trial (MK-6621) formulation w/ MRK

Cardiovascu lar Systems CSII

$13.13

$228

In MAY 2011, received FDA clearance to complete enrlmt of 429 pts for treatment of calcified heart vessel (coronary) lesions following Diamondbac rvw of initial data from 50 pts, k 360 ClinicalTrials.gov ID Orbital NCT01092416 w/ expected Phase 3 (ORBIT Atherectomy completion of trial during 12/31/12 II) Clinical Trial System 4Q12

8/4/11

Cardium

CXM

$0.21

$18

FDA Decision 510(k) Medical 12/31/11 Device

Excellagen (2.6% collagen topical gel pre-filled syringes)

During 2Q11 submitted manufacturing info to FDA in support of 510(k) submission, seeking marketing clearance for topical wound management for a variety of dermal wounds, believes it has addressed all outstanding issues w/ estimated FDA decision by late 2011-early 2012 but no formal decision deadline

8/2/11

Catalyst Pharma Partners

CPRX

$1.30

$28

Pivotal Phase 2b / 3 Clinical 12/31/12 Trial

Expects to complete pt enrlmt (200) during 1H12 and report top-line results during 4Q12 for ongoing study in collaboration w/ Natl Inst. Drug Abuse (NIDA) for Vigabatrin patients w/ cocaine addiction, Oral Tablets ClinicalTrials.gov ID (CPP-109) NCT01281202

8/16/11

CEL-SCI Corp.

CVM

$0.39

$82

6/30/12

Multikine (immunotherapy mixture of Pivotal Phase 3 naturally (IT-MATTERS) derived Clinical Trial cytokines)

ClinicalTrials.gov ID NCT01265849 w/ results expected mid-2012 for Phase 3 study of Multikine plus standard of care (SOC) vs. SOC treatment only previously untreated pts w/ advanced squamous cell carcinoma of the oral cavity or soft palate 5/17/11 In AUG 2011, opened enrlmt for randomized P2 trial for pts w/ newly diagnosed brain cancer (GBM) in combo w/ radiation (RT) vs. temozolomide (TMZ) plus RT, ClinicalTrials.gov ID NCT01402063 w/ results expected 2H13

Cell Therapeutic s CTIC

$1.13

$219

OPAXIO (paclitaxel poliglumex, CT-2103) Phase 2 Clinical (formerly 12/31/13 Trial XYOTAX)

8/19/11

Cell Therapeutic s CTIC

$1.13

$219

FDA Resubmission (NDA) (4Q11), MAA / EMA (Europe) Decision (1Q12), Pivotal Phase 3 (PIX-R) PIXUVRI Clinical Trial (pixantrone 12/31/11 (4Q12) dimaleate)

Expects to resubmit NDA in response to CRL during 4Q11w/ anticipated Class 2 six-month review, expects to receive EMA opinion on European approval decision for non-Hodgkin's lymphoma (NHL) 1Q12 following 120-day response on 8/23/11, ClinicalTrials.gov ID NCT01321541 w/ results expected 4Q12 for P3 B-cell lymphoma trial 8/23/11

Celldex Therapeutic s CLDX

$2.64

$117

In AUG 2011, announced finalized protocol for pending Rindopepim P3 trial expected to enroll up ut (CDXto 374 pts at 150 global sites 110) w/ newly-diagnosted brain (therapeutic cancer (GBM) and begin Pending Phase brain cancer during 2H11 along w/ P2 trial 3 (ACT IV) and vaccine alone or in combo w/ Phase 2 Clinical targeting AVASTIN for recurrent or 12/31/11 Trials EGFRvIII) refractory GBM

8/3/11

Celldex Therapeutic s CLDX

$2.64

$117

Phase 2b 12/31/11 Clinical Trial

In SEP 2010, began P2B trial in glycoprotein NMB (GPNMB) expressing CDX-011 refractory breast cancer (glembatumumab patients, expects to complete vedotin) enrollment of 120 patients by (monoclonal year-end 2011, antibodyClinicalTrials.gov ID drug NCT01156753, received FDA conjugate) Fast Track Status in May 2010 ClinicalTrials.gov ID NCT00948961 w/ results expected during 4Q11 to assess safety, immune response and anti-tumor activity in combo w/ immune stimulating agents for pts w/ cancers that express tumor antigen NY-ESO-1

8/3/11

Celldex Therapeutic s CLDX

$2.64

$117

Phase I / II 12/31/11 Clinical Trial

CDX-1401 (NY-ESO-1 tumor antigen targeting human monoclonal antibody)

8/3/11

Celsion

CLSN

$3.61

$95

On 6/8/11, announced DSMB recommended trial advance to P2 portion after review of ThermoDox safety data from P1 portion for (doxorubicin treatment of recurrent chest encapsulate wall (RCW) breast cancer, Phase I / II Open-d in a heat- ClinicalTrials.gov ID Label (DIGNITY) activated NCT00826085 w/ final results 12/31/13 Clinical Trial liposome) expected late 2013-early 2014

8/9/11

Celsion

CLSN

$3.61

$95

In AUG 2011, completed pt enrlmt (600) in ongoing pivotal P3 trial in combo w/ RFA for primary liver cancer (HCC), expects to reach trigger of 190 ThermoDox PFS events during 3Q11 for (doxorubicin planned interim efficacy encapsulate analysis during 4Q11 and final Pivotal Phase 3 d in a heat- data expected in 2012, ClinicalTrials.gov ID (HEAT) Clinical activated 12/31/11 Trial under SPA liposome) NCT00617981 8/10/11

Chelsea Therapeutic s CHTP

$4.18

$259

9/30/11

NORTHERA (droxidopa) FDA New Filing (orally active (NDA), Phase 2 synthetic Clinical Trial, precursor of Phase 3 Clinical norepinephri Trial ne)

Expects to file NDA during 3Q11 seeking approval for treatment of symptomatic NOH (neurogenic orthostatic hypotension), ongoing P3 trial (Study 306) for potential falls claim indication w/ results expected during 2Q12, expects to report top-line results from ongoing P2 trial by yr-end 2011 for treatment of fibromyalgia

8/8/11

Chelsea Therapeutic s CHTP

$4.18

$259

9/30/11

CH-4051 (orally available anti-folate agent) (LPhase 2 Clinical isomer of Trial CH-1504)

In MAY 2011, announced DSMB rvw of safety data and trial continued as planned to begin enrlmt of high-dose groups for treatment of for rheumatoid arthritis compared to treatment with methotrexate, expects to report un-blinded interim efficacy data in SEP 2011 w/ full results expected during 2Q12 7/26/11

Columbia Labs

CBRX

$2.14

$187

2/26/12

FDA Decision (NDA)

On 6/27/11 FDA accepted NDA w/ PDUFA decision goal date of 2/26/12 under standard 10-month rvw, received $5M milestone pmt from partner WPI for accepted NDA (due to receive $30M upon US commercialization), seeking approval to reduce Prochieve risk preterm birth in women w/ (8% Progest- short cervix in mid-trimester of erone Gel) pregnancy 6/27/11

Corcept Therapeutic s CORT

$2.75

$232

2/17/12

FDA Decision (NDA)

On 6/30/11, announced FDA accepted NDA w/ PDUFA decision goal date of 2/17/12 under standard 10-month review, seeking approval for treatment of the hormonal disorder Cushing's Syndrome, CORLUX in AUG 2011 reported no (mifepriston advisory panel mtg will be e) scheduled to rvw NDA 8/22/11 On 9/6/11, amended agmt w/ Shiva Biomedical to extend start of pt dosing in pivotal trial to 1Q12, expects to report results from ongoing biomarker proof of concept trial by end 3Q11 to support start of pivotal trial during 1H12

CorMedix

CRMD

$1.04

$11

9/30/11

Deferiprone (CRMD001) (a novel oral, twice-daily formulation of ironPhase 2 Clinical binding drug) Trial

9/6/11

CorMedix

CRMD

$1.04

$11

On 7/7/11 announced filing for CE Mark (Europe) for prevention of catheter-related Neutrolin blood infections and to Pending Pivotal (CRMD003) maintain catheter patency in Phase 3 (1.35% dialysis catheters w/ expected (Medical taurolidine, decision during 1H12, expects Device) Clinical 4% citrate to begin pivotal P3 trial (FDA) Trial (2H11), CE and during 2H11 following JUN Mark (Europe) 1000u/mL 2011 request for designation 12/31/11 Decision (1H12) heparin) filing

7/7/11

Cubist Pharma

CBST

$32.46

$1,983

3/31/13

On 8/1/11, announced start of pivotal P3 trials in pts w/ complicated urinary tract infections (cUTI) (ClinicalTrials.gov IDs NCT01345929 and CXA-201 NCT01345955 w/ results (novel expected 1Q13), expects to cephalospori begin P3 trial for complicated n antibiotic intra-abdominal infections in combo (cIAI) by yr-end 2011 and P3 Pivotal Phase 3 with trials for hospital-acquired Clinical Trials tazobactam) pneumonia in 2012

8/1/11

Curis

CRIS

$3.00

$230

On 6/20/11, announced partner Roche presented pivotal P2 trial data in pts w/ Vismodegib advanced basal cell (GDC-0449) carcinoma (BCC) and expects to file NDA in 2011 based on (RG3616) (Hedgehog positive results which met primary endpt, median pathway inhibitor, anti- duration of response was 7.6 months and progression-free FDA New Filing cancer agent) survival (PFS) was 9.5 months 6/20/11 12/31/11 (NDA)

Cyclacel Pharma

CYCC

$0.74

$40

9/30/11

In JAN 2011, began enrolling pts in pivotal P3 trial as frontline treatment of elderly patients w/ newly diagnosed Sapacitabin acute myeloid leukemia e (CYC682) (AML), DSMB review expected during 3Q11 to enable start of Phase 2 Clinical (oral Trial, Pivotal capsules) (a randomized portion of trial Phase 3 nucleoside expected to complete enrlmt 2H12 w/ final results 2H13, (SEAMLESS) analogue Clinical Trial anti-cancer expects to present P2 lung cancer data 2H11 8/12/11 under SPA agent)

Cytokinetics CYTK

$1.10

$79

Expects to report results from ongoing P2A trial for amyotrophic lateral sclerosis (ALS) (Lou Gehrigs disease) by year-end 2011, expects to CKreport results from ongoing 2017357 (a P2A trial for myasthenia gravis fast skeletal by year-end 2011, expects to muscle report P1 drug / drug Phase 1 and 2a troponin interaction trial results during 12/31/11 Clinical Trials activator) 2H11 7/29/11

Cytokinetics CYTK

$1.10

$79

6/30/13

Phase 2b Clinical Trial

In APR 2011, began enrolling pts w/ partner AMGN for treatment of acute heart failure, expects to enroll 600 pts in 3 ascending-dose groups compared to placebo, ClinicalTrials.gov ID NCT01300013 w/ results Omecamtiv expected during 1H13, Mecarbil discussing plans w/ AMGN to (intravenous begin clinical trials for oral formulation) formulation of the drug

7/29/11

Cytomedix

CMXI

$0.38

$19

6/30/12

FDA Decision 510(k)

On 9/1/11, announced submission of FDA 510(k) seeking marketing clearance for expanded use of device for processing a mix of both blood and bone marrow as a source of platelet rich plasma (PRP) Angel Whole containing stem cells, Blood estimated FDA reply by midSeparation 2012 but no formal decision System deadlines for med devices

9/1/11

Cytori Therapeutic s CYTX

$3.01

$162

CE Mark Clearance, EU Indication-forUse Decision, Pivotal European (ADVANCE) 12/31/11 Clinical Trial

Began enrolling pts 1Q11 for pivotal EU acute heart attack (MI) trial and expects to complete pt enrlmt during 1H13, expects to receive CE Mark clearance for next-gen Celution One by yr-end 2011, expected indication-for-use decision (EU) for no-option chronic myocardial ischemia Celution pts by early 2012 (1Q12 One System estimate)

8/10/11

CytRx

CYTR

$0.36

$53

3/31/12

ClinicalTrials.gov ID NCT00520208 w/ results expected 1Q12 for ongoing STAR-1 study under SPA for relapsed or refractory acute promyelocytic leukemia (APL), ClinicalTrials.gov ID Tamibaroten NCT01337154 for ongoing trial in combo w/ paclitaxel and e (oral carboplatin for advanced nonsynthetic retinoid anti- small-cell lung cancer (NSCLC) w/ results expected Phase 2 Clinical cancer 2H12 Trials agent)

8/1/11

CytRx

CYTR

$0.36

$53

In APR 2011, began open label P1B trial (ClinicalTrials.gov ID NCT01337505 w/ results expected 4Q11) in up to 24 pts w/ primarily soft tissue INNO-206 sarcomas that failed standard (tumortreatments and expects a P2B Phase 1b targeting pro- trial for soft tissue sarcomas in Clinical Trial, drug of 2011, FDA Orphan drug Pending Phase chemo drug status for pancreatic cancer 12/31/11 2b Clinical Trial doxorubicin) and sarcoma

8/9/11

CytRx

CYTR

$0.36

$53

On 6/13/11, reported prelim P2 results for B-cell chronic lymphocytic leukemia (B-CLL) pts (16) w/ evidence of clinical Bafetinib activity and low incidence of (formerly adverse events and will enroll INNO-406) more pts, ClinicalTrials.gov (an orally NCT01144260 w/ results available, expected during 1H12, dual Bcr-Abl ClinicalTrials.gov ID and Lyn NCT01215799 w/ results Phase 2 Clinical kinase expected 4Q11 for P2 prostate 12/31/11 Trials cancer trial 6/13/11 inhibitor) In JUN 2011, reported positive safety results in P1A trial and expects to report results of DB959 (dual ongoing P1B trial during PPAR delta / 3Q11, being developed as oral drug for treatment of type gamma 2 diabetes 6/28/11 agonist)

DARA BioSciences DARA

$1.96

$10

9/30/11

Phase 1b Clinical Trial

DARA BioSciences DARA

$1.96

$10

Pending Phase 12/31/11 2 Clinical Trial

KRN5500 (novel spicamycin derivative, IV formulation)

Expects to begin second P2 trial for during 2H11, in AUG 2011 received FDA Fast Track status for treatment of chemoinducted neuropathic (nerve) pain in pts w/ cancer 8/18/11

Delcath Systems

DCTH

$3.69

$177

Expects to re-file 505(b)(2) NDA by year-end 2011 in response to FEB 2011 refusal to file letter from FDA requesting addtl manufacturing and safety data, seeking approval for the Delcath local delivery of melphalan in Percutaneou patients w/ metastatic s Hepatic melanoma in the liver, on FDA New Filing Perfusion 9/1/11 reported P2 colon (NDA), Phase 2 (PHP) cancer spread to liver trial 12/31/11 Clinical Trial System failed had no sig responses

9/1/11

DepoMed

DEPO

$5.78

$320

In MAR 2011, completed enrlmt in pivotal P3 trial for the non-hormonal treatment of menopausal hot flashes w/ results expected during 4Q11 (mid-late OCT 2011 estimate), same drug approved by FDA Pivotal Phase 3 SERADA as GRALISE for post-herpetic (BREEZE-3) (extended neuralgia (nerve pain that Clinical Trial release persists after shingles 10/31/11 under SPA gabapentin) infection) in JAN 2011

8/1/11

Derma Sciences

DSCI

$8.09

$85

6/30/12

In MAY 2011, reported P2 trial data for diabetic foot ulcer pts DSC127 (an w/ a 27% wound healing Angiotensin improvement vs. placebo, analog, a expects to conduct end of P2 Pending Pivotal naturally mtg w/ FDA during 4Q11 and Phase 3 Clinical occurring begin pivotal P3 trial during Trial peptide) 1H12 8/16/11 On 7/29/11, announced plans to file for FDA approval during 4Q11 and EU approval during 1H12 for disposable delivery device for pts on ventilator support to receive aerosolized medications 7/29/11

Discovery Labs

DSCO

$2.08

$50

AFECTAIR (disposable delivery device for aerosolized 12/31/11 FDA New Filing medicine)

Discovery Labs

DSCO

$2.08

$50

9/16/11

FDA Reply to Accept NDA Resubmission and Issue PDUFA Decision Date

On 9/2/11 submitted complete response to CRL issued by FDA in 2009, seeking approval for the prevention of respiratory distress syndrome SURFAXIN (RDS) in premature infants, (lucinactant) expected FDA reply in two (synthetic, weeks (9/16/11) to accept peptideNDA and issue PDUFA containing decision goal date w/ a sixlung month Class 2 review period surfactant) expected

9/6/11

Durect Corp. DRRX

$1.37

$120

On 9/6/11, announced dosing of last pt in ongoing pivotal P3 trial for novel long-acting (3day) formulation of approved POSIDUR drug bupivacain for post(Saber surgical pain relief w/ top-line Bupivdata expected during 4Q11 to acaine) Post- support planned NDA filing Pivotal Phase 3 Operative 1H12, ClinicalTrials.gov ID (BESST) Pain Relief NCT01052012, US partner is 12/31/11 Clinical Trial Depot HSP, EU partner is Nycomed

9/6/11

Dyax

DYAX

$1.47

$145

In AUG 2011, began treating pts in ongoing P2 trial for acute treatment of angiotensin converting enzyme (ACE) inhibitor-induced angioedema KALBITOR (severe allergic reaction), FDA (ecallantide) approved as KALBITOR for (reversible treatment of acute attacks of inhibitor of hereditary angioedema, Phase 2 Clinical plasma expects to report results 12/31/12 Trial kallikrein) during 2H12

8/5/11

Dynavax

DVAX

$2.24

$276

DV1179 Phase I Clinical (TLR7&9 12/31/11 Trial inhibitor)

On 4/20/11, began dosing in Phase I trial expected to enroll 24 healthy subjects divided into three dose groups, partnered w/ GSK and will receive $6M milestone pmt for starting the trial, being developed for treatment of lupus, expects to report data later this year (2H11 estimate) 4/20/11 On 7/28/11, announced FDA agreed manufacturing consistency demonstrated in P3 trial that concluded in JUL 2011, plans to file BLA by yearend 2011 w/ ongoing P3 trial in chronic kidney disease pts w/ results expected in early 2012 (1Q12 estimate) 7/28/11

Dynavax

DVAX

$2.24

$276

FDA New Filing (BLA) (4Q11), HEPLISAV Phase 3 Clinical (hepatitis B 12/31/11 Trial (1Q12) vaccine)

Echo Therapeutic s ECTE

$3.84

$132

9/30/11

FDA Decision 510(k) Medical Device

Prelude SkinPrep and 4% Lidocaine Cream

On 2/8/11, announced expected 510(k) marketing clearance during 3Q11 based on FDA feedback to partner Ferndale Pharma (private), seeking approval as fasteracting local anesthetic (skin numbing agent prior to needle sticks), will receive $750,000 milestone pmt upon FDA approval plus double-digit royalties

2/8/11

Elan

ELN

$10.00

$5,867

6/30/12

Experimental treatment for mild to moderate Alzheimer's disease (AD), PFE and JNJ also have stakes in the development of this compound while Elan has retained approx. 25% stake, ClinicalTrials.gov IDs NCT00574132 with results Bapineuzum expected during 3Q12 and Phase 3 Clinical ab (AABNCT00575055 w/ results Trial 001) expected 2Q12

8/17/11

Endo Pharma

ENDP

$30.34

$3,537

FDA Decision 12/13/11 (NDA)

OPANA ER (new formulation of extendedrelease oxymorphon e)

On 6/23/11, announced FDA accepted its complete response to JAN 2011 CRL seeking approval for new formulation of pain drug designed to deter abuse, PDUFA decision goal date of 12/13/11

6/24/11

Endocyte

ECYT

$10.92

$388

6/30/13

Expects to file MAA during 1Q12 seeking EMA / EU EC145 approval for treatment of pts (folate w/ folate-receptor positive receptor platinum-resistant ovarian targeted anti- cancer, in MAY 2011 began cancer enrolling pts in pivotal P3 trial agent) and w/ companion diagnostic EC20 (EC20) to identify folate overPivotal Phase 3 (companion expression, ClinicalTrials.gov (PROCEED) imaging ID NCT01170650 w/ results Clinical Trial diagnostic) expected mid-2013

8/12/11

EnteroMedic s ETRM

$2.40

$67

3/31/13

Maestro RC2 System (VBLOB Pivotal Phase 3 Vagal Nerve Blocking (ReCharge) Device) Clinical Trial

Expects to complete pt enrlmt by yr-end 2011 for ongoing pivotal P3 trial in obese pts, ClinicalTrials.gov ID NCT01327976 w/ results expected late 2012-early 2013 8/17/11

Enzon Pharma

ENZN

$8.21

$400

On 5/19/11, announced decision to discontinue program for metastatic colon cancer after ongoing P2 trial PEG-SN38 completed w/ (PEGylated ClinicalTrials.gov ID form of the NCT00931840 and results active expected 4Q11, metabolite of ClinicalTrials.gov ID the cancer NCT01036113 for P2 trial in pro-drug pts w/ previously treated Phase 2 Clinical Camptosar / metastatic breast cancer w/ 12/31/11 Trials irinotecan) results expected 2H11

5/19/11

EpiCept

EPCT

$0.38

$27

Phase I / II 12/31/12 Clinical Trial

Crolibulin (EPC2407) (vascular disruption anti-cancer agent)

In DEC 2010, NCI / NIH began P1/2 trial in combo w/ cisplatin for pts w/ solid tumors (focusing on anaplastic thyroid cancer), ClinicalTrials.gov ID NCT01240590 w/ results expected during 2H12 8/15/11 Expects to submit pivotal P3 trial protocol w/ SPA request to FDA during 2H11 for treatment of chemo-induced neuropathic pain, seeking partner to fund P3 trial 8/15/11

EpiCept

EPCT

$0.38

$27

Pending Pivotal Phase 3 Clinical Trial w/ SPA 12/31/11 Request

AmiKet (topical analgesic cream)

EpiCept

EPCT

$0.38

$27

Pending Confirmatory Phase 3 Clinical Trial w/ SPA Request, PostMarketing (Europe) 12/31/11 Clinical Trial

CEPLENE (histamine dihydrochloride)

Expects to meet w/ FDA during 3Q11 to discuss proposed confirmatory P3 trial w/ SPA request for treatment of acute myeloid leukemia (AML) in first remission, ongoing post-approval study in Europe w/ initial data from 75 pts expected in early 2012 (1Q12 estimate) 8/15/11

EXACT Sciences

EXAS

$7.44

$392

9/30/12

Cologuard (stool DNA Pivotal (DeeP- based C) Clinical Trial molecular (Medical Device diagnostic / Diagnostic) test)

In JUL 2011, announced start of pivotal trial for diagnostic screening test for early detection of colorectal cancer and pre-cancers (CRC), expects to enroll 10-12,000 subjects over approx. 12 months at cost of $20M, ClinicalTrials.gov ID NCT01397747 w/ results expected during 3Q12 to support planned PMA filing in 2012

8/3/11

Exelixis

EXEL

$6.69

$863

9/30/11

Expects to report top-line data in pivotal P3 trial for medullary Cabozantini thyroid cancer around end of 3Q11 to support planned Pivotal Phase 3 b (XL184) rolling NDA filing during 4Q11 (EXAM) Clinical (MET, Trial under SPA, VEGFR2, (1Q12 estimate to complete), Pending Pivotal and RET expects to begin pivotal P3 Phase 3 Clinical inhibitor anti- trial under SPA by yr-end Trial w/ SPA cancer 2011 for castration-resistant Request agent) prostate cancer (CRPC)

8/5/11

Forest Labs FRX

$33.08

$9,082

On 7/18/11, reported positive stat sig P3 results for treatment of depression in Levomilnaci adults, expects to report pran (1S,2R- results from two addtl P3 milnacipran) results by year-end 2011 and (active spring 2012 as the isolated enantiomer active compound found in Phase 3 Clinical of marketed depression drug 12/31/11 Trials LEXAPRO) LEXAPRO Aclidinium Bromide (long-acting inhaled antimuscarinic agent) On 6/30/11 announced NDA submission seeking approval for treatment of lung condition (COPD), expected FDA decision by 4/30/12 under a standard 10-month review period

7/18/11

Forest Labs FRX

$33.08

$9,082

4/30/12

FDA Decision (NDA)

6/30/11

Furiex Pharma

FURX

$13.64

$135

1/25/12

On 7/25/11, partner Takeda announced two NDA resubmissions based on interim cardiovascular safety results seeking approval for new type of drug for type 2 Alogliptin diabetes both alone and in and combo w/ marketed diabetes Alogliptin / drug ACTOS w/ expected sixPioglitazone month FDA rvw and decision FDA Decisions (ACTOS) by 1/25/12, FURX due to (Two NDA Fixed-Dose receive $25M on approval and Resubmissions) Combo royalties 7/26/11 JNJ32729463 (novel, broadspectrum fluoroPhase 2 Clinical quinolone Trial antibiotic) Partnered with JNJ, ClinicalTrials.gov ID NCT01198626 with results expected mid-2012 (2-3Q12) for treatment of patients requiring hospitalization for community-acquired bacterial pneumonia

Furiex Pharma

FURX

$13.64

$135

9/30/12

8/4/11

Furiex Pharma

FURX

$13.64

$135

9/30/11

JNJ27018966 (Mu Delta) (mu opioid receptor agonist, Phase 2 Clinical delta Trial antagonist)

Last pt completed P2 trial for pts w/ diarrhea-predominant irritable bowel syndrome in JUL 2011, ClinicalTrials.gov ID NCT01130272 w/ results expected during 3Q11, FDA Fast Track status announced in JAN 2011, partnered w/ JNJ

8/4/11

Generex Biotech

GNBT

$0.10

$30

9/30/11

ClinicalTrials.gov ID NCT00668850 for 26-week open-label randomized P3 (084) trial that will be closed in AUG 2011 w/ results expected during 3Q11, evaluating oral insulin spray w/ regular human insulin in type 1 Generex diabetics, plans to conduct Oral-lyn addtl P3 trials that are (buccal Phase 3 Clinical insulin spray expected to be completed product) during 2013 Trial

8/2/11

Gen-Probe

GPRO

$57.53

$2,772

3/31/12

FDA Advisory Panel Meeting, FDA Decision (PMA)

On 8/29/11, SEC 8-K filing indicated FDA Advisory Panel mtg delayed until 1Q12 to provide more time to rvw addtl info submitted in support of PMA originally submitted in SEP 2010, developed as molecular diagnostic test (urine samples) to help determine need for repeat PROGENSA biopsies in men suspected of PCA3 Assay having prostate cancer 8/29/11

Gen-Probe

GPRO

$57.53

$2,772

3/31/12

FDA Decision (PMA)

In NOV 2010, submitted PMA seeking marketing clearance for molecular diagnostic test to detect high-risk HPV infections associated w/ cervical cancer and preAPTIMA cancerous lesions in women, HPV estimated FDA reply in late (human 2011-early 2012 but no formal papilloma- decision deadlines for medical virus) Assay devices / diagnostics 8/29/11

Gen-Probe

GPRO

$57.53

$2,772

3/31/12

FDA Decision 510(k)

PANTHER System

In MAY 2010 announced FDA 510(k) submission seeking marketing clearance for fully automated molecular diagnostic testing system to run tests such as APTIMA Combo 2 (chlamydia and gonorrhea test), received CE Mark (Europe) in DEC 2010, estimated FDA reply early-mid 2012 but no formal decision deadline for med devices 8/29/11 Expects to report ongoing P1 trial results in pts w/ advanced solid tumors during 4Q11 to support start of P2 trial for castrate-resistant prostate cancer during 4Q11 7/21/11

GenSpera

GNSZ

$1.83

$41

G-202 Phase I Clinical (thapsigargi Trial, Pending n pro-drug Phase 2 Clinical anti-cancer 12/31/11 Trial agent)

Gentium

GENT

$6.36

$95

11/1/11

MAA / EMA (Europe) Decision

Defibrotide

On 6/1/11, announced MAA seeking approval for prevention and treatment of hepatic veno-occlusive disease (VOD) of the liver following stem cell transplant was accepted for accelerated review (150 days) for expected EMA decision by 11/1/11, in AUG 2011 withdrew NDA citing issues related to data and conduct of trials 8/18/11

GeoVax Labs

GOVX

$0.85

$13

6/30/12

Phase 2a (HVTN 205) (HIV Vaccine Trials Network Sponsored) Clinical Trial

On 12/9/10, reported early results in ongoing blinded study indicating no safety concerns and favorable immune (T cell) responses in HIV (Human 180 pts to date, study initiated ImmunoJAN 2009 w/ HVTN and NIH, deficiency expects to complete pt enrlmt Virus) in 2011 w/ full study results Preventative expected in 2012 (1H12 Vaccine estimate)

6/21/11

GeoVax Labs

GOVX

$0.85

$13

3/31/12

Phase I / II Clinical Trial

In MAY 2010, the AIDS Research Consortium of Atlanta received approval to begin enrollment of 10-12 pts, HIV (Human expects P1/2 trial to begin Immunogenerating vaccine safety and deficiency performance data late 2011Virus) early 2012 (1Q12 estimate), Therapeutic added third clinical site for trial Vaccine in JUN 2011 6/23/11

Geron

GERN

$2.58

$333

6/30/12

Ongoing Phase 2 studies include ClinicalTrials.gov ID NCT01137968 (results expected mid-2012 for lung cancer), NCT01256762 GRN163L (results expected 1Q13 for (imetelstat breast cancer), NCT01243073 sodium) (results expected 1Q13 for (telomerase essential thrombocythemia), inhibitor anti- NCT01242930 (results Phase 2 Clinical cancer stem expected 1Q13 for multiple Trials cell agent) myeloma) 6/20/11

Geron

GERN

$2.58

$333

In JUN 2011, presented data on first two spinal cord injury pts w/ no safety concerns, GRNOPC1 ClinicalTrials.gov ID (a human NCT01217008 with results embryonic expected during 4Q12, stem cell or received FDA clearance to hESC expand eligibility criteria and Phase I Clinical product shorten time lag to 10 days 12/31/12 Trial candidate) between enrlmt of new pts

7/29/11

Gilead Sciences

GILD

38.57

$29,755

9/30/11

QUAD single-tablet HIV regimen of elvitegravir, cobicistat and TRUVADA (emtricitabin Pivotal Phase 3 e and Clinical Trial tenofovir)

On 8/15/11, announced first of two pivotal P3 trials (Study 102) met primary endpt of noninferiority to ATRIPLA for treatment of HIV-1 infection, second P3 trial (Study 103) w/ results expected during 3Q11 to support planned NDA filing in early 2012 8/15/11

Given Imaging

GIVN

$14.31

$434

6/30/12

Pivotal Clinical Trial to Support FDA 510(k) Submission

PillCam COLON 2 video capsule endoscopy

In JUN 2011, began enrolling pts in ongoing pivotal study for product , designed to visualize the colon in average risk population unwilling to undergo colonoscopy as less invasive alternative test, received CE Mark (Europe) in SEP 2009, ClinicalTrials.gov ID NCT01372878 w/ results expected mid-2012 8/26/11

GTx, Inc.

GTXI

$3.29

$206

Phase 2b 12/31/11 Clinical Trial

CAPESARIS (GTx-758) (oral selective estrogen receptor alpha agonist)

In JUN 2011, began openlabel P2b trial compared to Lupron Depot for first-line treatment advanced prostate cancer, expects to report primary efficacy results by yrend 2011, expects to begin two addtl P2 trials during 2H11

8/26/11

GTx, Inc.

GTXI

$3.29

$206

3/31/13

In JUL 2011 began two ongoing pivotal P3 trials for prevention and treatment of muscle wasting in patients OSTARINE with non-small cell lung (GTx-024) cancer (NSCLC), (selective ClinicalTrials.gov IDs androgen NCT01355484 and Pivotal Phase 3 receptor NCT01355497 w/ results Clinical Trials modulator) expected 1Q13

8/26/11

Guided Therapeutic s GTHP

$0.90

$44

On 8/10/11, announced start of human testing for lightbased detection of Barretts Esophagus (esophageal cancer precursor condition), Biophotonic being developed w/ Konica Disease Minolta, expects to enroll 40 Detection subjects and complete testing 12/31/11 Feasibility Study Platform by yr-end 2011 FDA Advisory Panel Meeting (1Q12 est) to Review PMA Filing, CE Mark (Europe) Decision (2H11 estimate)

8/10/11

Guided Therapeutic s GTHP

$0.90

$44

3/31/12

LuViva Advanced Cervical Scan and Guide

On 9/1/11, announced that it provided requested info to FDA in support of PMA submission , FDA may request more info or schedule advisory panel mtg during 1Q12

9/1/11

Halozyme Therapeutic s HALO

$6.28

$651

4/30/12

FDA Decision (BLA)

In JUL 2011, licensee BAX reported positive P3 results for novel formulation of IG (dosed once every 3-4 weeks) used in HyQ (subcutaneo pts w/ primary us immune immunodeficiency in support globulin / IG of a BLA filing which has formulation expected FDA decision date of 4/30/12 under a standard 10with rHuPH20 / month review period, HALO hyaluronidas due to receive milestone pmts e enzyme) and royalties under 2007 agmt 7/11/11

Halozyme Therapeutic s HALO

$6.28

$651

9/30/11

Ultrafast PH20Phase 2 Clinical Insulin Trials Analogs

In SEP 2010, began two P2 trials w/ one in Type 1 diabetics (Clinical Trials.gov ID NCT01194245) and one in Type 2 diabetics (ClinicalTrials.gov ID NCT01194258) w/ pt enrlmt completed in JAN 2011 and results expected 3Q11

6/21/11

Hansen Medical

HNSN

$3.82

$210

FDA Decision 510(k) Medical 12/31/11 Device

Magellan Robotic System

On 7/25/11, announced CE Mark received for system to assist physicians for peripheral vascular disease device placements (e.g. stents), expects full market launch in Europe during 1H12, announced FDA 510(k) submission in APR 2011 w/ estimated FDA decision during 4Q11 but no formal decision deadline

7/25/11

HeartWare

HTWR

$59.86

$834

HeartWare FDA Decision Ventricular (PMA) (Medical Assist 12/31/11 Device) System

On 3/16/11, FDA accepted PMA submission for full review, seeking marketing clearance as a bridge to heart transplantation for patients with end-stage heart failure, official filing date is 12/28/10 w/ estimated FDA decision during 4Q11 but no formal decision deadlines for medical devices 3/17/11

Horizon Pharma

HZNP

$8.16

$156

9/30/11

Expects to file NDA during 3Q11 seeking approval for novel formulation of approved LODOTRA steroid drug for reduction in (NP01) morning stiffness associated (programme with rheumatoid arthritis (RA), d-release approved in Europe, IPO on FDA New Filing low-dose 7/28/11 for 5.5M shares (NDA) prednisone) priced @$9

7/29/11

Idenix Pharma

IDIX

$5.43

$522

IDX184 (hepatitis C virus, HCV Pending Phase nucleotide 12/31/11 2b Clinical Trial pro-drug)

On 2/9/11, announced FDA removed full clinical hold (due to elevated liver function tests) and placed on partial clinical hold, expects to begin a P2B trial during 2H11 in combo w/ pegylated interferon and ribavirin for hepatitis C virus (HCV) infection 6/21/11

Idera Pharma

IDRA

$1.65

$46

Pending Phase 12/31/11 2 Clinical Trial

IMO-2125 (TLR9 Agonist) ICT-107 autologous (patientderived) dendritic cell (DC) therapeutic cancer vaccine

In APR 2011, announced delay to planned start of 12week P2 trial in combo w/ ribavirin for chronic hepatitis C virus (HCV) infection pending chronic non-clinical toxicology study data that is expected 2H11 In FEB 2011, first pt enrolled in trial for treatment of brain cancer (GBM), expects to enroll up to 200 pts by mid2012 and complete P2B trial by late 2013 w/ interim results expected during 2H12, ClinicalTrials.gov ID NCT01280552

8/5/11

ImmunoCellular Therapeutic s IMUC

$1.55

$44

Phase 2b 12/31/12 Clinical Trial

7/22/11

Immunomedics

IMMU

$3.83

$289

3/31/14

Epratuzuma b (monoclonal antibody targeting CD22 receptors on Pivotal Phase 3 B(EMBODY 1 & lymphocytes 2) Clinical Trials )

Licensed to UCB for all autoimmune indications, began enrolling pts in two pivotal trials in DEC 2010 for moderate to severe lupus (SLE) to enroll 780 pts each and last max of 54 weeks, ClinicalTrials.gov IDs NCT01262365 & NCT01261793 w/ results expected 1Q14

6/27/11

ImmunoGen IMGN

$10.40

$794

6/30/12

Partner Roche expects to report P3 (EMILIA) trial data mid-2012 to support FDA and EMA approval filings soon after for second-line treatment of HER2+ metastatic breast cancer (MBC), ongoing P3 Phase 2 Clinical (MARIANNE) study for firstTrial, Pivotal Trastuzuma line treatment of MBC to Phase 3 (EMILIA) Clinical b DM1 (Tsupport planned approval Trial DM1) filings in 2014 8/17/11 On 8/15/11, announced third pivotal P3 trial for pts w/ advanced Parkinsons disease (PD) to improve motor symptoms met primary endpt, plans to file NDA during 4Q11 w/ partner GSK expected to file MAA for EU approval in 2012 8/15/11

Impax Labs IPXL

$18.33

$1,205

IPX066 (extendedrelease carbidopa FDA New Filing plus 12/31/11 (NDA) levodopa)

Incyte

INCY

$14.50

$1,830

3/31/12

Phase 2b Clinical Trial

On 10/20/10, earned $19M milestone payment from partner LLY, which initiated Phase 2b study for treatment of rheumatoid arthritis (RA), LY3009104 expects to complete pt enrlmt (an oral during 2H11 and complete JAK1/JAK2 three-month double-blind, inhibitor) placebo-controlled phase of (formerly the trial in early 2012 (1Q12 INCB28050) estimate)

7/28/11

Incyte

INCY

$14.50

$1,830

6/30/13

On 7/28/11, announced enrlmt behind schedule and plans to work w/ FDA to amend study protocol to accelerate pt Pivotal Phase 3 recrmt, ClinicalTrials.gov ID (RESPONSE) Ruxolitinib NCT01243944 w/ results Clinical Trial (INCB18424 expected mid-2013, partnered under SPA ) w/ NVS 7/28/11

Incyte

INCY

$14.50

$1,830

12/3/11

FDA Decision (NDA), MAA / EMA (Europe) Decision

On 8/3/11, announced FDA accepted NDA w/ PDUFA decision goal date of 12/3/11 under six-month priority rvw seeking approval for treatment of myelofibrosis, ex-US partner NVS submitted MAA in Ruxolitinib JUN 2011 w/ estimated EU (INCB18424 approval decision by late 2011early 2012 8/3/11 )

Infinity Pharma

INFI

$7.00

$186

3/31/12

In FEB 2011 began P2 portion of P1b/2 trial in combo w/ GEMZAR for pancreatic cancer and expects to complete pt enrlmt by yearend 2011, ClinicalTrials.gov ID NCT01130142 w/ results IPI-926 expected 1Q12, P2 sarcoma (Hedgehog trial w/ ClinicalTrials.gov ID Pathway NCT01310816 and results Inhibitor anti- expected 4Q12, expects to Phase 2 Clinical cancer begin P2 trial for myelofibrosis Trials agent) during 3Q11 6/23/11

Inhibitex

INHX

$3.07

$240

3/31/12

INX-189 (oral, oncedaily NS5b Phase 2 Clinical nucleotide Trials inhibitor)

On 8/8/11, reported plans to begin P2 trial next week for treatment of chronic hepatitis C virus (HCV) infection in combo w/ pegylated interferon and ribavirin in genotype (GT) 2 and 3 treatment nave HCV pts w/ interim data expected 1Q12, expects to begin P2 trial in GT1 treatment nave HCV pts during 4Q11

8/8/11

Inovio Pharma

INO

$0.67

$85

Pennvax Phase I Clinical HIV DNA 12/31/11 Trials Vaccines

Expects to final immune response and safety data from two P1 trials in HIV-positive volunteers by yr-end 2011

8/8/11

Inovio Pharma

INO

$0.67

$85

On 7/14/11, reported significant immune responses SynCon generated in P1 trial of avian Universal flu vaccine, launched second Flu Vaccine P1 trial to evaluate minimally (VGX-3510) invasive skin delivery w/ data (H1N1 expected 4Q11, subjects seasonal + being screened for a P1 trial of Phase I Clinical H5N1 avian universal flu vaccine w/ interim 12/31/11 Trials influenza) data expected 1Q12 7/14/11

Inovio Pharma

INO

$0.67

$85

VGX-3100 (cervical cancer DNA vaccine delivered via Cellectra electroPhase 2 Clinical poration 12/31/13 Trial device)

In MAR 2011, began trial for cervical dysplasia (CIN 2/3 or CIN 3 pre-cancerous condition) caused by HPV, expects to enroll 148 pts at 25 global sites, ClinicalTrials.gov ID NCT01304524 w/ results expected during 2H13

8/8/11

InSite Vision INSV

$0.53

$50

AZASITE (Azithromycin Phase 2 Clinical Ophthalmic 12/31/11 Trial Solution) DexaSite (ISV-305) (dexamethaosone ), AzaSite Plus (ISV502) (dexaPending Pivotal methasone Phase 3 Clinical & azithro12/31/11 Trial under SPA mycin)

In DEC 2010, partner Inspire Pharma (acquired by MRK in APR 2011) began trial in up to 300 pts w/ blepharitis (eyelid inflammation) at 25 US sites, expects to report data during 2H11, INSV receives AZASITE royalties

4/6/11

InSite Vision INSV

$0.53

$50

On 5/25/11, announced SPA agmt w/ FDA for P3 trial of AzaSite Plus and DexaSite in pts w/ blepharitis (chronic eyelid inflammation), expects to enroll 900 pts in four arms, estimate to begin trial during 2H11

5/25/11

InSite Vision INSV

$0.53

$50

Pending Phase 12/31/11 3 Clinical Trial

On 3/22/11, reported Phase 1 / 2 trial top-line results met ISV-303 (low- primary endpt to reduce pain dose and inflammation associated bromfenac with eye surgery, plans to delivered discuss design of pivotal with Phase 3 program w/ FDA after DuraSite final study analysis (2H11 technology) estimate for Phase 3 trial) 3/22/11

Insmed

INSM

$4.10

$102

On 8/2/11, announced FDA placed clinical hold on planned P3 trials for treatment of cystic fibrosis (CF) pts w/ Pseudomonas lung infections and pts w/ non-tuberculous mycobacterial lung disease Pending Pivotal ARIKACE based on concerns over longPhase 3 Clinical (liposomal term rat cancer study, expects Trials -- FDA amikacin for to reply w/in 30 days for 2H11 12/31/11 Clinical Hold inhalation) estimate for FDA reply

8/2/11

Insulet

PODD

$16.85

$797

FDA Decision 510(k) Medical 12/31/11 Device

OmniPod Insulin Managemen t System (nextgeneration insulin pump)

In MAY 2011 submitted 510(k) seeking FDA marketing clearance for next-generation insulin pump (33% smaller, 25% lighter) w/ estimated FDA decision by yr-end 2011, received CE Mark clearance (Europe) in late JUL 2011

8/3/11

INSYS Therapeutic s (planned IPO as INRX) NEOL

$9.05

$4

ClinicalTrials.gov ID NCT01190982 w/ results expected during 4Q11 for an open-label study being conducted in India for pts w/ LEP-ETU metastatic breast cancer, (novel novel formulation designed to formulation increase solubility, decrease of antiinfusion-related side effects, cancer drug and allow for administration of Phase 2 Clinical paclitaxel or higher doses of the active 12/31/11 Trial TAXOL) drug Expected PDUFA decision goal date of 1/4/12 under standard 10-month review, seeking FDA approval for treatment of breakthrough Fentanyl Sublingual cancer pain episodes as a single-unit dose device that is Spray (Fentanyl SL designed for rapid absorption Spray) and pain relief

6/28/11

INSYS Therapeutic s (planned IPO as INRX) NEOL

$9.05

$4

1/4/12

FDA Decision (NDA)

5/20/11

IntelGenx

IGXT

$0.69

$32

FDA Decision 11/13/11 505(b)(2) NDA

On 8/2/11, announced Pillar5 Pharma passed pre-approval manufacturing inspection w/ no outstanding issues CPI-300 reported by FDA (Form 483), (450mg PDUFA decision goal date of bupropion) 11/13/11 under six-month (novel, high- Class 2 NDA resubmission in strength response to FEB 2010 CRL formulation) issued by FDA

8/2/11

InterMune

ITMN

$25.26

$1,535

3/31/13

On 7/7/11, announced start of pt enrlmt in pivotal P3 trial for treatment of idiopathic pulmonary fibrosis (IPF) (lung disease), expects to complete enrlmt during 1H12 and report results mid-2013 to support potential NDA resubmission to CRL during 2H13, Pivotal Phase 3 ClinicalTrials.gov ID (ASCEND) ESBRIET NCT01366209, received EU Clinical Trial (pirfenidone) approval in MAR 2011

7/8/11

IRIS International IRIS

$7.78

$139

FDA Decision 510(k) Medical 12/31/11 Device

NADiA ProsVue (a prostate cancer prognostic test)

During 2Q11 submitted all requested info and software validation data in support of FDA 510(k) submission seeking marketing clearance to identify men at low risk of prostate cancer recurrence after surgical removal w/ estimate for FDA decision by late 2011-early 2012

8/4/11

Ironwood Pharma

IRWD

$11.39

$1,143

6/9/12

FDA Decision (NDA)

Linaclotide (orally administere d, once-daily medication that increases fluid in the intestinal tract)

On 8/9/11, announced NDA filing w/ partner FRX seeking approval for irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC), expected FDA decision by 6/9/12 under standard 10-month review period, European partner Almirall expects to submit MAA during 2H11

8/10/11

Isis Pharma ISIS

$7.01

$699

6/30/12

On 7/28/11, announced MAA filing seeking EMA approval for treatment of two genetic disorders (HoFH & HeFH) KYNAMRO resulting in very high (mipomerse cholesterol levels w/ estimated FDA New Filing, n) (RNAdecision by mid-2012, expects MAA / EMA based ApoB to file for FDA approval later (Europe) this year (2H11 estimate), synthesis Decision partnered w/ SNY 7/28/11 inhibitor)

ISTA Pharma

ISTA

$3.88

$130

In MAY 2011, began P3 trials for low-dose BROMDAY (0.09% once-daily dose approved by FDA in OCT BROMDAY 2010 for post-op inflammation Lower and pain for cataract eye Phase 3 Clinical Concentratio surgery), expects to report 12/31/11 Trials n results during 4Q11

7/29/11

ISTA Pharma

ISTA

$3.88

$130

REMURA (bromfenac ophthalmic Phase 3 Clinical solution for 12/31/11 Trial under SPA dry eye)

On 7/28/11, announced first of two P3 trials under SPA failed to meet co-primary endpts for treatment of dry eye, expects to report top-line results from second P3 trial during 4Q11 7/29/11

Keryx Biopharma

KERX

$3.80

$265

6/30/12

ZERENEX (ferric citrate) (an iron-based Pivotal Phase 3 phosphate Clinical Trials binder to (US and EU) treat under SPA (and elevated equivalent EMA phosphorus designation for in dialysis Europe) patients)

In NOV 2010, reported shortterm efficacy study met all primary and secondary endpts, long-term safety study (58-week study in approx. 300 patients) initiated SEP 2010 and expects to complete during 2Q12 to support potential NDA filing 3Q12, Japan partner JT Torii began Phase 3 program APR 2011

7/8/11

Keryx Biopharma

KERX

$3.80

$265

On 8/31/11, announced indpt data safety monitrg bd completed interim analysis and recmd trial continue as planned in pivotal P3 trial for Perifosine metastatic colorectal cancer, (KRX-0401) North American rights to (PI3K/Akt perifosine in-licensed from Pivotal Phase 3 pathway AEZS, FDA Fast Track status, (X-PECT) inhibitor anti- ClinicalTrials.gov ID Clinical Trial cancer NCT01097018 w/ results 12/31/11 under SPA agent) expected late 2011-early 2012 8/31/11

Keryx Biopharma

KERX

$3.80

$265

In DEC 2009, began relapsed / refractory multiple myeloma (MM) pivotal trial, Perifosine ClinicalTrials.gov ID (KRX-0401) NCT01002248 w/ results (PI3K/Akt expected during 4Q12, FDA pathway Orphan Drug / Fast Track Pivotal Phase 3 inhibitor anti- status, North American rts to Clinical Trial cancer perifosine in-licensed from 12/31/12 under SPA agent) AEZS

7/8/11

Lexicon Pharma

LXRX

$1.18

$398

6/30/12

Phase 2b Clinical Trial

LX4211 (once-daily oral selective SGLT2 inhibitor)

In JUN 2011, began enrolling pts w/ type 2 diabetes in P2B trial expected to enroll 285 adults not adequately controlled on metformin over 12 weeks to evaluate several doses, ClinicalTrials.gov ID NCT01376557 w/ results expected during 2Q12

8/9/11

Ligand Pharma

LGND

$13.89

$273

On 7/26/11, partner GSK reported positive results in first of two P3 trials w/ full results expected during 2H11 to support potential sNDA filing during 2Q12 to expand approval to include treatment PROMACTA of pts w/ hepatitis C related Phase 3 (ENABLE-1 and (eltrombopa thrombocytopenia (low platelets) 7/26/11 12/31/11 2) Clinical Trials g)

Ligand Pharma

LGND

$13.89

$273

Phase 2 Clinical Trial (4Q11), Pending Pivotal CaptisolPhase 3 Clinical enabled 12/31/11 Trial (1Q12) melphalan

Expects to report full results of ongoing P2 trial during 4Q11 w/ planned start of pivotal P3 trial in early 2012 (1Q12 estimate) that is designed to enroll 60 pts and support 505(b)(2) NDA filing by mid2013 contingent upon trial data, being developed as improved formulation of marketed drug for use in multiple myeloma pts as pretransplant chemotherapy 6/22/11

Lpath

LPTN

$0.96

$58

6/30/12

Phase 1b Clinical Trial

iSONEP (S1P inhibitor antibody)

In DEC 2010, entered deal w/ PFE to develop treatment for wet age-related macular degeneration (wet AMD) and other eye disorders w/ upfront payment of $14M and costsharing agmt, ClinicalTrials.gov ID NCT01334255 for P1b trial for treatment of wet AMD complication (PED) w/ results expected mid-2012 6/14/11 In OCT 2010, first patient dosed to evaluate safety / tolerability and immune / clinical response for advanced melanoma (skin cancer), ClinicalTrials.gov ID NCT01026051 w/ results expected during 3Q12

MannKind

MNKD

$3.14

$411

9/30/12

MKC1106MT (therapeutic cancer vaccine, Phase 2 Clinical immunoTrial therapy)

6/2/11

MannKind

MNKD

$3.14

$411

Pivotal Phase 3 Clinical Trials (Study 171 and 174) to Support NDA 12/31/12 Resubmission

AFREZZA (insulin human [rDNA origin]) Inhalation Powder

In AUG 2011 met w/ FDA to confirm design of two pivotal P3 trials to address JAN 2011 CRL, seeking approval for inhaled insulin for treatment of adults w/ type 1 & 2 diabetes, estimate to complete trials by FDA by late 2012-early 2013 to support planned NDA resubmission 8/12/11

MAP Pharma

MAPP

$12.70

$386

3/26/12

FDA Decision (NDA)

On 8/2/11, announced NDA accepted for filing by FDA w/ PDUFA decision goal date of 3/26/12 under a standard 10month review, seeking approval for orally inhaled LEVADEX drug for treatment of acute (dihydromigraine headaches as a new ergotamine inhaled formulation of or DHE oral approved drug DHE, inhaler) partnered w/ AGN

8/2/11

Medgenics

MDGN

$3.57

$36

Phase I / II 12/31/11 Clinical Trial

EPODURE bio-pump (six-month erythropoieti n / EPO delivery)

Expects to report full results during 4Q11 from ongoing P1/2 dose-ranging trial for treatment of anemia in pts w/ chronic kidney disease (CKD), ClinicalTrials.gov ID NCT00542568 8/23/11

Medicines Company

MDCO

$13.81

$746

In NOV 2010, announced SPA agmt w/ FDA for pivotal trials in pts w/ acute bacterial skin and skin structure infection (ABSSSI) to compare single dose of oritavancin vs. Oritavancin multiple doses of vancomycin, Pivotal Phase 3 (glycoClinicalTrials.gov IDs Clinical Trials peptide intra- NCT01252719 and (SOLO-1 and 2) venous NCT01252732 w/ results 12/31/12 under SPA expected during 4Q12 6/16/11 antibiotic)

MediciNova MNOV

$2.24

$34

Phase 2 (MN221-CL-007) 12/31/11 Clinical Trial

In MAY 2011 reported 1Q11 results and provided guidance to report results of ongoing P2 trial by year-end 2011, MN-221 ClinicalTrials.gov ID (highly NCT00838591 for intravenous selective 2- (IV) administration as add-on adrenergic to standard therapy in adults w/ acute asthma receptor agonist) exacerbations 7/11/11

Medivation

MDVN

$17.48

$610

6/30/12

In APR 2011, reported P3 trial for Huntington disease failed to meet co-primary endpts, ongoing P3 CONCERT trial for mild-moderate Alzheimers disease in combo w/ Aricept top-line data expected during 1H12, ClinicalTrials.gov ID Phase 3 Clinical Dimebon NCT00829374, partnered w/ Trial (latrepirdine) PFE 8/10/11 Co-developed w/ Astellas, expects to report interim results for P3 AFFIRM trial w/ ClinicalTrials.gov ID NCT00974311 by yr-end 2011 and top-line results in 2012, PREVAIL P3 study began SEP 2010, began Phase 2 TERRAIN study for advanced prostate cancer MAR 2011 and open-label trial for first-line treatment in MAY 2011 8/10/11

Medivation

MDVN

$17.48

$610

Phase 3 (AFFIRM and PREVAIL) Clinical Trials, Phase 2 Clinical 12/31/11 Trials

MDV3100 (oral androgen receptor antagonist)

MELA Sciences

MELA

$2.26

$57

FDA Decision (PMA) Medical Device / Diagnostic, CE Mark (Europe) 12/31/11 Decision

MelaFind (computer vision system for early melanoma detection)

In FEB 2011 filed amended PMA to limit proposed use to dermatologists based on NOV 2010 advisory panel feedback, on 5/12/11 submitted second amendmt to PMA w/ training program, has requested mtg w/ FDA, 2H11 estimate for FDA reply or update on PMA status along w/ pending CE Mark (Europe) submission

8/9/11

Micromet

MITI

$4.35

$400

3/31/13

In SEP 2010, began pivotal EU trial in pts w/ minimal residual disease B-precursor acute lymphoblastic leukemia Blinat(ALL), ClinicalTrials.gov ID umomab NCT01207388 w/ results Pivotal (MT103) (a expected during 1Q13, in JUN European Phase lymphoma- 2011 reported P2 interim trial 2 (BLAST) directed, data in adults w/ relapsed ALL Clinical Trial recombinant w/ 75% of pts achieving (4Q12) antibody) complete remission (CR) 6/10/11

Myrexis (formerly Myriad Pharma)

MYRX

$2.77

$72

6/30/13

Phase 2a and Phase 2b Clinical Trials

In JUN 2011, presented P2a brain cancer (GBM) trial data w/ median overall survival of 9.9 month, began P2b trial in DEC 2010 for front-line treatment of GBM in combo w/ standard of care to enroll up to 120 GBM pts, AZIXA (MPC- ClinicalTrials.gov ID 6827) NCT01285414 w/ results (verubulin) expected during 1H13

6/6/11

Nabi Biopharma

NABI

$1.84

$79

NicVAX Pivotal Phase 3 (Nicotine Clinical Trial Conjugate 12/31/11 under SPA Vaccine)

In JUL 2011, announced first pivotal P3 trial did not meet primary endpt w/ 11% quit smoking rate that was similar to placebo, was well tolerated w/ no safety concerns, second pivotal P3 trial ongoing, ClinicalTrials.gov ID NCT01102114 w/ results expected late 2011-early 2012, partnered w/ GSK

8/4/11

Nektar Therapeutic s NKTR

$5.28

$604

9/30/12

In MAR 2011, partner AZN announced enrlmt of first pt in NKTR-118 trial for treatment of opioidinduced constipation (OIC), (oral peripherally- ClinicalTrials.gov ID Pivotal Phase 3 acting opioid NCT01309841 w/ results antagonist) expected 3Q12 Clinical Trials

7/19/11

Nektar Therapeutic s NKTR

$5.28

$604

3/31/12

ClinicalTrials.gov ID NCT00806156 w/ results expected during 1Q12 for open-label P2 trial in pts w/ NKTR-102 metastatic platinum-resistant (topoovarian cancer, plans to begin isomerase I P3 trial in 2011, also plans to Phase 2 Clinical inhibitor, begin P3 trial for metastatic Trials, Pending long-acting breast cancer w/ P2 trial Phase 3 Clinical polymer results to be presented on 9Trial conjugate ) Sept

8/5/11

Neoprobe

NEOP

$2.79

$248

6/30/12

Pending Pivotal Phase 3 Clinical Trial w/ SPA Request

RIGScan CR (tumorspecific targeting agent)

On 3/7/11, completed pre-IND mtg w/ FDA including SPA request as part of amended IND filing as radiopharmaceutical product for detection of colorectal cancer tumors, expects to finalize P3 trial protocol during 2H11 and begin manufacturing to support start of trial during 1H12 5/27/11

Neoprobe

NEOP

$2.79

$248

ClinicalTrials.gov ID NCT00911326 w/ results expected during 4Q12 for ongoing P3 trial in pts w/ head and neck cancer, being Phase 3 Clinical evaluated as a sentinel lymph 12/31/12 Trial Lymphoseek node tracing agent 7/28/11

Neoprobe

NEOP

$2.79

$248

On 8/10/11, announced NDA filing seeking approval for use in Intraoperative Lymphatic Mapping for breast cancer and FDA Reply to melanoma, expected FDA Accept NDA reply within 60 days Filing and Issue (10/10/11) to accept NDA for PDUFA review and issue PDUFA 10/10/11 Decision Date Lymphoseek decision goal date 8/11/11 AMR-001 (autologous or patientderived bone marrow based regenerative cell therapy) Expects to begin P2 trial during 4Q11 for treatment of heart attack (acute myocardial infarction or AMI) and P1 trial for heart failure in 2012, expects to complete enrlmt in P2 trial w/in 12 months and report top-line data by mid2013 8/24/11

NeoStem

NBS

$0.65

$64

Pending Phase 12/31/11 2 Clinical Trial

Nephros

NEPH

$2.07

$21

3/31/12

FDA Decision 510(k)

Hemodiafiltration (HDF) System

On 8/11/11, announced FDA 510(k) submission seeking marketing clearance for dialysis filtration system (OLpur MD220 diafilter and OLpur H2H Hemodiafiltration module) for pts w/ end-stage renal (kidney) disease, estimate for FDA reply during 1Q12 but no formal decision deadlines

8/12/11

Neptune

NEPT

$3.31

$169

9/30/12

CaPre (Neptune Krill Oil derived Phase 2 Clinical omega-3 Trial fatty acid)

On 6/30/11, received Health Canada clearance to conduct P2 randomized, double-blind, placebo-controlled trial in approx. 430 pts w/ moderately to very high triglycerides, estimate to complete trial by mid-2012 (2-3Q12 estimate) 7/29/11

Neuralstem CUR

$1.25

$61

Phase 1a 10/31/11 Clinical Trial

NSI-189 (neuron growth stimulator)

In JUN 2011, was cleared to dose final cohort of pts in ongoing P1A trial (ClinicalTrials.gov ID NCT01310881) to test safety of experimental drug for major depression, expects to complete the trial in summer to support planned start of P1B trial by early fall (OCT 2011 estimate) 8/11/11

Neuralstem CUR

$1.25

$61

6/30/12

On 6/14/11, updated status of ongoing P1 trial for treatment of ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease), safety monitoring board reviewed data from first NSI12 pts and approved 566RSC continuation of trial, next three (human pts due to receive injections spinal cord pending FDA approval (3Q11 estimate), ClinicalTrials.gov ID derived Phase I Clinical neural stem NCT01348451 (mid-2012 results) 6/14/11 Trial cells) Expects to begin P2 trial in SEP 2011 for treating the symptoms of tardive dyskinesia (TD) in 32 pts over two-week dosing period, expects to report three-month toxicology results during 4Q11, plans to conduct P2B trial in early 2012 Expects to begin P3 trial for uterine fibroids during 3Q11 and begin P3 trial for endometriosis during 4Q11, partnered w/ ABT

Neurocrine Biosciences NBIX

$5.76

$318

9/30/11

Pending Phase 2 Clinical Trial

NBI-98854 (VMAT2 Inhibitor) ELAGOLIX (orally active non-peptide GnRH antagonist)

7/29/11

Neurocrine Biosciences NBIX

$5.76

$318

9/30/11

Pending Phase 3 Clinical Trials

7/29/11

Nile Therapeutic s NLTX

$0.65

$23

As of 8/15/11, all subjects enrolled in low-dose cohort in Part B of ongoing P1 trial for heart failure pts (utilizing partner Medtronics insulin pump technology), expects to complete enrlmt during 4Q11, Cenderitide ClinicalTrials.gov ID Phase I Clinical (natriuretic NCT01316432 w/ results 12/31/11 Trial peptide) expected during 4Q12 DCVaxBrain (patientderived, dendritic cell Phase 2 Clinical immune Trial therapy)

8/15/11

Northwest Biotherapeut ics NWBO

$0.46

$43

6/30/12

In MAY 2011, announced 4 US sites actively enrolling new pts in ongoing P2 trial for treatment of brain cancer (GBM), ClinicalTrials.gov ID NCT00045968 w/ results expected mid-2012 8/26/11

NovaBay Pharma

NBY

$0.85

$24

Phase 2b 12/31/12 Clinical Trial

NVC-422 (Aganocide antimicrobial compound)

Partner Galderma will manage P2B trial for treatment of for impetigo (skin infection) w/ results expected during 2H12 8/17/11

NovaBay Pharma

NBY

$0.85

$24

NVC-422 (Aganocide antiPhase 2 Clinical microbial 12/31/11 Trial compound) Seasonal and Pandemic Influenza VLP (VirusPending Phase Like 1 and 2 Clinical Particle) 12/31/11 Trials Vaccines

Expects to report prelim results from ongoing P2 trial for prevention of urinary catheter blockage and encrustation during 4Q11 to support start of pivotal trial in 2012, being developed as medical device (PMA) for maintenance of catheter patency

8/17/11

Novavax

NVAX

$1.73

$199

Awarded HHS BARDA contract in FEB 2011 including $97M for 36-month base period, expects to begin seasonal flu vaccine P2 trials during 4Q11 and pandemic flu vaccine P1 trial in early 2012 8/15/11

Novavax

NVAX

$1.73

$199

9/30/11

During 2Q11, completed enrlmt of 150 subjects in ongoing P1 trial to assess Respiratory safety and immune response Syncytial in adults for experimental RSV Virus Fusion vaccine w/ interim top-line Protein data expected during 3Q11, Phase I Clinical (RSV-F) ClinicalTrials.gov ID Trial Vaccine NCT01290419 8/15/11

NPS Pharma

NPSP

$6.85

$589

In MAR 2011, announced randomization of last pt (135) in pivotal trial for bioengineered formulation of PTH for hormone replacement therapy to treat hypoparathyroidism, expects to NPSP558 report top-line data during (human 4Q11, will present data from Pivotal Phase 3 parathyroid two investigator-initiated (REPLACE) hormone or studies in SEP 2011 at 12/31/11 Clinical Trial PTH) medical mtg

8/3/11

NPS Pharma

NPSP

$6.85

$589

On 8/18/11, submitted initial CMC section of NDA seeking approval as once-daily subcutaneous treatment for Gattex (US short bowel syndrome (SBS), expects to complete NDA filing brand name), 4Q11, EU partner Nycomed FDA New Filing Revestive submitted MAA for EU (NDA), EMA / (EU brand approval in MAR 2011 MAA (Europe) name) seeking approval w/ estimated 12/31/11 Decision (teduglutide) decision during 4Q11 8/18/11

Nymox Pharma

NYMX

$7.67

$251

NX-1207 (administere d by urologist at office in a few minutes for benign prostatic Pivotal Phase 3 hyperplasia 12/31/12 Clinical Trials or BPH)

ClinicalTrials.gov IDs NCT00918983 & NCT00945490 w/ results expected from both pivotal P3 trials during 2H12, in APR 2011 reported new 39-45 month follow-up data w/ no safety concerns and 11.5 point improvement in BPH (enlarged prostate) symptoms

8/17/11

Omeros

OMER

$3.75

$83

6/30/12

Phase 3 clinical program will evaluate safety and efficacy in improving post-operative joint OMS103HP function and reducing pain (novel following arthroscopic partial formulation meniscectomy (knee) surgery of w/ two P3 trials and first trial ketoprofen, (North America) data expected amytriptyline during 1H12, plans to begin , and second trial in Europe during Phase 3 Clinical oxymetazoli 4Q11, a novel formulation of Trials ne) approved drugs 6/13/11

Omeros

OMER

$3.75

$83

6/30/12

OMS302 (novel formulation of antiinflammatory and pupil dilation / Phase 3 Clinical mydriasis drugs) Trials

Phase 3 program will evaluate the safety and efficacy in patients undergoing intraocular (eye) lens replacement surgery, first trial (North America) w/ data expected during 1H12 and second trial in Europe will begin following discussions to validate pivotal study design and endpoints 6/13/11

Omthera Pharma (PRIVATE)

N/A

N/A

N/A

ClinicalTrials.gov ID NCT01242527 w/ results expected 4Q11 (plans to file NDA based on these results) EPANOVA for P3 (EVOLVE) study for (novel treatment of very high formulation triglycerides (TGs) (over 500), of EPA and ClinicalTrials.gov ID Pivotal Phase 3 DHA omega- NCT01408303 w/ results (EVOLVE and 3 fatty acids expected 3Q12 for P3 ESPRIT) to improve (ESPRIT) study as add-on to Clinical Trials biostatin drugs for TGs of 20012/31/11 under SPA availability) 500 to expand use

8/16/11

OncoGenex Pharma OGXI

$10.50

$102

Phase 3 (SATURN and SYNERGY) 12/31/13 Clinical Trials

Phase 3 SATURN trial for castrate-resistant prostate cancer (CRPC) pts w/ disease progression, ClinicalTrials.gov ID NCT01083615 w/ results expected during 4Q13, Phase 3 SYNERGY trial ClinicalTrials.gov ID Custirsen NCT01188187 w/ results Sodium expected during 4Q13 for first(OGX-011 / line treatment CRPC, TV-1011) partnered w/ TEVA

8/5/11

Oncolytics Biotech

ONCY

$3.58

$255

Pivotal Phase 3 Clinical Trial under SPA (mid2012), Phase 2 Clinical Trials REOLYSIN 12/31/11 (2H11) (Reovirus)

In MAY 2010, began pivotal P3 trial in combo w/ paclitaxel and carboplatin for platinumrefractory head and neck cancer, ClinicalTrials.gov ID NCT01166542 w/ final results expected mid-2012, multiple ongoing P2 trials including pancreatic cancer (NCT00998322 4Q11), head / neck cancer (NCT00753038 2H11), lung cancer (NCT00861627 2H11)

7/15/11

Oncothyreon ONTY

$7.17

$301

6/30/12

In DEC 2010, indpt data monitoring cmte (DMC) gave ok to continue study in pts w/ non-small cell lung cancer (NSCLC) w/ second interim STIMUVAX analysis expected 2H11 and (BLP25 top-line data expected by midPivotal Phase 3 liposome 2012 for pivotal P3 trial in (START) therapeutic 1476 pts, partnered w/ Merck Clinical Trial cancer KGaA, ClinicalTrials.gov ID under SPA vaccine) NCT00409188 6/22/11

Oncothyreon ONTY

$7.17

$301

3/31/13

Three ongoing P2 trials for solid tumors, metastatic colorectal or head / neck cancer, and brain cancer PX-866 (PI- (GBM) w/ initial data expected 3-kinase / during 2H11 and final data PTEN / AKT expected during 2H12, pathway ClinicalTrials.gov IDs include inhibitor anti- NCT01204099, Phase 2 Clinical cancer NCT01252628, and Trials agent) NCT01259869 6/22/11

Onyx Pharma

ONXX

$31.42

$1,997

On 3/29/11, announced plans to expand (from 84 to 300 pts) FDA New Filing pivotal European FOCUS trial (NDA) (3Q11), Carfilzomib for relapsed / refractory Pivotal Phase 3 (selective multiple myeloma (MM), Combo proteasome expects to complete NDA filing (ASPIRE) inhibitor anti- during 3Q11 seeking Clinical Trial cancer accelerated approval in US for 12/31/11 (4Q11) agent) MM w/ FDA Fast Track status

7/1/11

Opko Health OPK

$3.93

$1,132

Ongoing validation study in 580 pts w/ positive initial results reported from 140 samples, final results Alzheimers expected by late 2011 (4Q11 Disease estimate), non-exclusive (AD) collaboration agmt w/ BMY for Antibodylead AD test w/ lung and Validation Study Based pancreatic markers (Molecular Diagnostic undergoing validation w/ 12/31/11 Diagnostic Test) Blood Test expected completion by 4Q12 7/14/11

OraSure

OSUR

$6.87

$323

OraQuick FDA New Filing HIV OTC 12/31/11 (PMA) Test Prochymal (remestemc el-L) (adult bone marrow derived stem Phase 2 Clinical cells for IV infusion) 12/31/11 Trial

Expects to complete ongoing clinical testing during 3Q11 for over-the-counter version of HIV diagnostic test via oral fluids w/ enrlmt closed on 8/9/11, expects to file PMA in three modules w/ first expected in AUG 2011 and expected completion of PMA filing by yr-end 2011 In MAR 2011, completed enrlmt for patients experiencing first heart attack (acute myocardial infarction), ClinicalTrials.gov ID NCT00877903 w/ results expected during late 2011early 2012

8/9/11

Osiris Therapeutic s OSIR

$5.04

$165

8/12/11

Osiris Therapeutic s OSIR

$5.04

$165

Prochymal (remestemc el-L) (adult bone marrow derived stem Phase 3 Clinical cells for IV infusion) 12/31/12 Trial

ClinicalTrials.gov ID NCT01233960 w/ results expected during 4Q12 for ongoing open-label P3 trial for treatment-refractory moderate to severe Crohns disease, resumed enrlmt of pts in this trial MAY 2010 8/12/11

OXiGENE

OXGN

$1.11

$16

6/30/12

In MAY 2011, began P1 trial for treatment of acute myelogenous leukemia (AML) OXi4503 or myelodysplastic syndrome (combretast (MDS), expects to report data atin A1 during 1H12, Phase I Clinical diphosphate ClinicalTrials.gov ID Trial or CA1P) NCT01085656

8/26/11

Pacira Pharma

PCRX

$7.71

$133

FDA Decision 10/28/11 (NDA)

EXPAREL (bupivacaine extendedrelease liposome injection) (300mg / 20mL)

On 6/14/11, announced threemonth delay due to addtl info submitted at FDA request, new PDUFA decision goal date is 10/28/11, seeking approval for post-surgical pain relief by local administration for a novel, long-acting formulation of approved drug bupivacaine 6/14/11

Palatin

PTN

$0.72

$25

ClinicalTrials.gov ID NCT01332214 w/ results expected during 4Q11 for ongoing P1 trial, being AZD2820 developed as single-agent (melanocorti therapy for obesity that is n receptor given via subcutaneous Phase I Clinical partial administration, developed in 12/31/11 Trial agonist) collaboration w/ AZN In JUN 2011, began enrolling pts in P2B trial for treatment of female sexual dysfunction Bremelanoti (FSD), expects to enroll 400 de pts at 40 sites w/ 16 wks of (previously treatment, expects to report PT-141) results during 2H12, (melanocorti ClinicalTrials.gov ID n agonist) NCT01382719 COTARA (targeted, anti-cancer monoclonal antibody, radioisotope combo)

8/5/11

Palatin

PTN

$0.72

$25

Phase 2b 12/31/12 Clinical Trial

8/5/11

Peregrine Pharma

PPHM

$1.23

$87

Pending Phase 12/31/11 3 Clinical Trial

In JUN 2011 presented P2 open-label trial data for brain cancer (recurrent GBM) w/ interim median overall survival of 8.8 months in 41 pts, plans to meet w/ FDA during 4Q11 to discuss pivotal development pathway 7/14/11

Peregrine Pharma

PPHM

$1.23

$87

Expects P2 front-line lung cancer (NSCLC) interim data by yr-end 2011, P2 secondline NSCLC data 1H12, P2 Bavituximab pancreatic cancer trial (monoclonal (ClinicalTrials.gov ID antibody that NCT01272791 results midtargets cell 2012), P2 hepatitis C virus membrane trial (NCT01273948) results component 1Q12, on 8/24/11 reported phosphatidyl- 20.7 median overall survival Phase 2 Clinical serine or (P2 single-arm breast cancer 12/31/11 Trials PS) trial)

8/24/11

Pharmacycli cs PCYC

$11.32

$682

Phase 1 and 2 12/31/11 Clinical Trials

Plans to begin P3 trials mid2012 for two types of lymphoma (CLL/SLL and MCL), expects to report PCI-32765 interim P2 data for MCL, (Btk inhibitor combo safety data for CLL and anti-cancer pilot data for DLBCL during agent) 2H11 8/17/11

Pharmacycli cs PCYC

$11.32

$682

Phase I / II 12/31/12 Clinical Trial

Being evaluated in ongoing P1/2 trial in pts w/ locally PCI-27483 advanced or metastatic (Factor 7a or pancreatic cancer with P1 FVIIa portion completed and expects inhibitor, to complete enrollment of P2 small portion by yr-end 2011, molecule ClinicalTrials.gov ID anti-cancer NCT01020006 w/ results agent) expected during 2H12 8/17/11

Pharmacycli cs PCYC

$11.32

$682

Phase I / II 12/31/11 Clinical Trial

PCI-24781 (HDAC inhibitor anticancer agent)

Ongoing P2 portion of trial in pts w/ follicular and mantle cell lymphoma w/ data expected by yr-end 2011 8/17/11

Pharmasset VRUS

$70.11

$5,287

9/30/11

On 8/24/11 received FDA Fast Track status for treatment of PSI-938 chronic hepatitis C virus (nucleotide (HCV) infection, expects to Pending Phase analog HCV begin interferon-free combo 2b (QUANTUM) polymerase P2 (QUANTUM) trial w/ PSIClinical Trial inhibitor) 7977 during 3Q11 8/24/11

Pharmasset VRUS

$70.11

$5,287

Phase 2b (ELECTRON) 12/31/11 Clinical Trial

On 9/6/11, reported sustained virologic response (SVR) results from P2B PROTON study in previously untreated pts w/ hepatitis C virus (HCV) genotype 1 infection 2/ 98% of PSI-7977 pts achieving SVR12 (12 (nucleotide wks), expects to begin combo analog HCV trial 3Q11 w/ PSI-938 and polymerase report results of P2B inhibitor) ELECTRON trial 2H11

9/6/11

Pharmasset VRUS

$70.11

$5,287

Phase 2b Clinical Trials, Pending Phase 12/31/11 3 Clinical Trial

Mericitabine (RG7128, MCB) (nucleoside analog HCV polymerase inhibitor)

Partnered with Roche, expects to begin Phase 2 trial for hepatitis C virus (HCV) genotype 2 / 3 pts during 1H11 and begin Phase 3 program during 2011 to support potential regulatory approval filings in 2013, PROPEL / JUMP-C trial final data expected during 4Q11 6/13/11

PolyMedix

PYMX

$0.60

$64

3/31/12

In FEB 2011, began P2 trial for reversal of heparin blood thinning effects in pts PMX-60056 undergoing Percutaneous (a synthetic, Coronary Intervention (PCI) procedures, will enroll up to 40 small pts in the US, molecule ClinicalTrials.gov ID blood NCT01312935 w/ results thinner / Phase 2 Clinical heparin expected late 2011-early 2012 Trial 6/21/11 antagonist) (1Q12 estimate) In SEP 2010, began P2 trial at multiple sites in Canada and Europe for treatment of acute PMX-30063 bacterial skin and skin (novel once- structure infections caused by daily Staph aureus, intravenous ClinicalTrials.gov ID or IV NCT01211470 w/ results antibiotic) expected during 4Q11 6/21/11

PolyMedix

PYMX

$0.60

$64

Phase I and II 12/31/11 Clinical Trials

PositiveID

PSID

$0.20

$9

3/31/12

FDA Decision 510(k)

iglucose

On 7/11/11, announced FDA 510(k) submission seeking marketing clearance for wireless communication system to facilitate diabetes mgmt by creating electronic journals of blood glucose readings and aid in insurance reimbsmt, estimated FDA reply during 1Q12 but no formal decision deadlines for medical devices

7/11/11

Pozen

POZN

$2.71

$81

3/31/12

ClinicalTrials.gov IDs NCT00960869 and NCT00961350 for ongoing sixmonth pivotal P3 efficacy trials w/ enrlmt completed and results expected 1Q12, ClinicalTrials.gov ID PA32540 NCT00995410 for open-label non-randomized 12-month (325mg enteric safety study which is coated completed w/ data analysis Pivotal Phase 3 aspirin plus ongoing to provide long-term Clinical Trials 40mg data for planned NDA filing under SPA omeprazole) 3Q12 8/29/11

Progenics

PGNX

$5.48

$185

In JUL 2011 completed pt enrlmt in ongoing P3 trial for treatment of opioid-induced RELISTOR constipation (OIC) in chronic Oral Tablets non-cancer pain pts w/ topPhase 3 Clinical (methylnaltr line results expected late 2011early 2012 8/9/11 12/31/11 Trial exone)

Progenics

PGNX

$5.48

$185

4/27/12

FDA Decision (sNDA)

On 8/30/11 announced FDA accepted sNDA, seeking expanded FDA approval for treatment of opioid-induced constipation (OIC) in pts w/ RELISTOR chronic non-cancer pain, Subcutaneo PDUFA decision goal date of us Injection 4/27/12 under standard 10(methylnaltr month rvw period, partnered exone) w/ SLXP

8/30/11

PROLOR Biotech

PBTH

$4.46

$159

6/30/12

Pending Phase 3 Clinical Trial

hGH-CTP (bio-better formulation of human growth hormone)

On 8/4/11, reported positive P2 trial results for long-acting once-weekly human growth hormone (hGH) formulation for treatment of GH deficiency in adults, expects to begin P3 trial in 2012 (1H12 estimate)

8/4/11

Protalix BioTherape utics PLX

$4.51

$386

2/1/12

FDA Decision (NDA)

On 8/17/11, announced FDA accepted NDA for review as six-month Class 2 UPLYSO resubmission in response to (taligluceras FEB 2011 CRL, seeking e alfa) (a approval for enzyme-based plant-cell treatment of Gaucher disease expressed w/ PDUFA decision goal date form of the of 2/1/12, submitted MAA for enzyme, EU aprvl in NOV 2010 w/ late glucocerebr 2011-early 2012 estimate for osidase) decision, partnered w/ PFE

8/17/11

pSivida

PSDV

$4.44

$92

ILUVIEN (fluocinolone FDA Decision intravitreal (NDA) (Class 2 insert) Resubmission), (sustained MAA / MHRA eye drug Decision delivery 11/12/11 (Europe) system)

In MAY 2011, licensee ALIM announced NDA resubmission to DEC 2010 CRL, seeking approval for diabetic macular edema w/ PDUFA decision goal date of 11/12/11 under a six-month Class 2 review w/ no advisory panel mtg to be held, MAA filed for EU approval in JUL 2010 w/ MHRA and expected decision during 1Q12, PSDV due to receive $25M on FDA approval 8/31/11

Qiagen

QGEN

$14.41

$3,371

6/30/12

FDA Decision (PMA)

On 8/5/11, announced second PMA submission seeking FDA marketing clearance as companion diagnostic for detection of KRAS mutations for use w/ two drugs for treatment of metastatic therascreen colorectal cancer, estimated KRAS RGQ FDA decision mid-2012 but no formal decision deadlines PCR Kit

8/5/11

QLT Inc.

QLTI

$7.07

$353

Phase 1b 12/31/11 Clinical Trial

QLT091001 (oral synthetic retinoid replacement therapy for 11-cisretinal)

Has completed enrlmt in Leber Congenital Amaurosis 14-pt cohort and expects to complete enrlmt in 14-pt Retinitis Pigmentosa cohort by yr-end 2011, ClinicalTrials.gov ID NCT01014052 w/ results expected during 1Q12 8/11/11

QLT Inc.

QLTI

$7.07

$353

9/30/11

Expects to report 4-week treatment results for reducing L-PPDS intraocular (eye) pressure in (latanoprost pts w/ glaucoma during 3Q11 punctal plug for novel delivery system of eye drug approved drug XALATAN eye Phase 2 Clinical delivery drops, ClinicalTrials.gov ID Trial system) NCT01229982

8/11/11

QRxPharma (QRX.AX) QRXPY

$7.01

$202

On 8/25/11, completed NDA filing w/ six-month priority review request following initial MoxDuo IR submission in JUL 2011, (immediate seeking FDA approval for FDA Reply to release 3:2 treatment of moderate to Accept NDA fixed-dose severe acute pain, expected Filing and Issue ratio combo FDA reply w/in two months PDUFA of morphine (10/25/11) to accept NDA Decision Goal and filing and issue PDUFA 10/25/11 Date oxycodone) decision goal date

8/25/11

Raptor Pharma

RPTP

$4.18

$145

DR Cysteamine Gelatin Capsules (delayedPhase 3 Open- release, Label Safety entericExtension coated Study, FDA New microbead 12/31/11 Filing (NDA) formulation)

On 7/25/11, reported pivotal P3 trial met primary endpt w/ no safety concerns vs. approved treatment (Cystagon) for metabolic disorder (cystinosis), expects to report six-month open-label extension trial data during 4Q11 to support planned early 2012 (1Q12 estimate) NDA filing 7/25/11

Regeneron Pharma

REGN

$68.37

$6,265

On 8/16/11, reported 3-month delay to 11/18/11 for BLA decision seeking approval for treatment of wet age-related macular degeneration, in JUN 2011 FDA Advisory Panel EYLEA voted 10-0 in favor of FDA Decision (aflibercept approval, co-developed w/ (BLA) ophthalmic Bayer (ex-US), expects to file (11/18/11), FDA solution) BLA 2H11 for treatment of New Filing (VEGF Trap- macular edema due to central 11/18/11 (BLA) (2H11) Eye) retinal vein occlusion

8/16/11

Regeneron Pharma

REGN

$68.37

$6,265

In APR 2011, reported P3 VELOUR trial met primary survival endpt for metastatic colon cancer, plans to file for FDA & EMA approval during 2H11, expects to report P2 AFFIRM final results (first-line colon cancer) 2H11 and P3 FDA New Filing VENICE (prostate cancer) final (BLA) (2H11), results in 2012 after JUL 2011 Phase 2 & 3 ZALTRAP Clinical Trials (aflibercept) interim analysis, co-developed 7/7/11 12/31/11 (2H11 to 2012) (VEGF Trap) with SNY

Regeneron Pharma

REGN

$68.37

$6,265

9/30/13

Phase 2b / 3 (MOBILITY) Clinical Trial

In JUL 2011, reported positive P2B trial results along w/ partner SNY for the treatment of rheumatoid arthritis (RA) in Sarilumab combo w/ methotrexate, will (REGN88) select dose(s) to be evaluated (SAR15319 in P3 portion of the trial, 1) (IL-6R ClinicalTrials.gov ID targeted NCT01061736 w/ results antibody) expected during 3Q13 7/13/11

Regeneron Pharma

REGN

$68.37

$6,265

9/30/11

ARCALYST (rilonacept) Subcutaneo us Injection (fusion protein that blocks cytokine FDA New Filing interleukin-1 (sBLA) or IL-1)

On 2/28/11, announced second Phase 3 trial for prevention of gout flares in pts receiving uric acid lowering therapy met all primary and secondary endpts, expects to file a sBLA mid-2011 (23Q11) to expand use of drug which is currently approved for inherited, auto-inflammatory conditions known as CAPS 6/28/11 On 8/24/11 completed enrlmt of 72 pts in ongoing P2 trial for dry eye syndrome, expects to complete treatment of all pts by 9/23/11 and report prelim data in OCT 2011, ClinicalTrials.gov ID NCT01387347 8/24/11

RegeneRx Biopharma

RGRX

$0.26

$21

RGN-259 (T4 Phase 2 Clinical ophthalmic 10/31/11 Trial solution)

Repligen

RGEN

$3.29

$101

3/31/12

Pilot Clinical Trial

SecreFlo (RG1068) for Pancreatic Imaging

On 7/21/11, announced first pt enrolled in pilot study to evaluate ability of RG1068 to improve pancreatic cancer detection in combo w/ MRI and CT scans, expects to enroll 40 pts, ClinicalTrias.gov ID NCT01371240 w/ results expected during 1Q12 7/21/11

Repligen

RGEN

$3.29

$101

SecreFlo (RG1068) for FDA New Filing Pancreatic 12/31/11 (NDA) Imaging

In MAR 2011 reported P3 trial met co-primary endpoints to improve magnetic resonance imaging (MRI) of the pancreas and in JUN 2011 announced conclusion of pre-NDA mtg w/ FDA, plans to submit NDA along w/ regulatory approval filings in Europe and Canada later this year (2H11 estimate) 7/27/11 In MAY 2011, provided update w/ 66 men w/ Type 2 diabetes randomized in trial, expects to report interim results and be fully enrolled (120-150 pts) in SEP 2011 and report top-line results for full study around year-end 2011, will present update on 9/12/11

Repros Therapeutic s RPRX

$4.76

$59

9/12/11

Androxal Phase 2 Clinical (enclomTrial iphene)

9/1/11

Repros Therapeutic s RPRX

$4.76

$59

9/12/11

Proellex (oral selective progestLow-Dose erone (Safety) Proellex receptor Clinical Trial modulator)

In JUN 2011, began enrolling subjects in 9mg cohort following safety rvw after 8 wks of dosing at 6mg w/ no signals of liver toxicity reported, enrolling 12 subjects per dosing group w/ 12mg as last in this study that is expected to be completed during 4Q11, will present update on 9/12/11 at R&R conf

9/1/11

Rexahn Pharma

RNN

$0.95

$90

Phase 2b 12/31/11 Clinical Trial

SERDAXIN (extended release clavulanic acid formulation)

In JUN 2010 completed pt enrlmt for treatment of major depressive disorder (MDD) w/ results expected during 4Q11 ClinicalTrials.gov ID NCT01028495 w/ pt enrlmt expected to continue thru 2011, being evaluated in combo with GEMZAR (gemcitabine) in patients w/ metastatic pancreatic cancer

8/17/11

Rexahn Pharma

RNN

$0.95

$90

ARCHEXIN (RX0201) (protein kinase Akt Phase 2a Open- inhibitor antiLabel Clinical cancer 12/31/11 Trial agent)

8/17/11

Rigel Pharma

RIGL

$7.07

$504

In SEP 2010, partner AZN began three pivotal P3 trials for rheumatoid arthritis (RA) pts taking methotrexate w/o responding, expects to report Fostamatinib initial data during 2H12 to support planned regulatory Pivotal Phase 3 disodium (OSKIRA-1,2,3) (oral agent aprvl filings in US and EU in for 2013, during 1Q11 began Clinical Trials, rheumatoid P2B mono-therapy trial in RA Phase 2b arthritis) pts w/ results expected 4Q12 12/31/12 Clinical Trial

8/2/11

Rockwell Medical

RMTI

$8.25

$149

6/30/12

Soluble Ferric Pyrophosph ate (SFP) (dialysate iron) (continuous Phase 2 iron (PRIME) Clinical replacement Trial therapy)

In FEB 2011, began enrolling pts to evaluate potential reduction in the need for erythropoietin stimulating agents (ESA) in dialysis patients receiving SFP, expects to complete enrlmt by yr-end 2011 and report results mid-2012, ClinicalTrials.gov ID NCT01286012 7/27/11

Rockwell Medical

RMTI

$8.25

$149

In MAR 2011, began enrolling pts (300 each) in pivotal trialsl to evaluate mean change in Soluble hemoglobin levels between Ferric SFP and placebo, expects to Pyrophosph complete enrlmt by yr-end ate (SFP) 2011 w/ results expected late (dialysate 2012 (4Q12 estimate) to iron) support planned NDA filing (continuous late 2012-early 2013, Pivotal Phase 3 iron ClinicalTrials.gov IDs (CRUISE-I & II) replacement NCT01320202 and 12/31/12 Clinical Trials therapy) NCT01322347

7/27/11

RXi Pharma RXII

$1.00

$42

6/30/12

NeuVax (peptidebased Pending Pivotal immunoPhase 3 therapy for (PRESENT) HER2+ Clinical Trial breast under SPA cancer)

In JUL 2011, acquired patent rts for use in combo w/ Herceptin and in low-tointmdte HER2+ breast cancer pts not eligible to receive Herceptin, expects to begin pivotal P3 trial (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression) under SPA during 1H12 7/13/11

Sangamo BioSciences SGMO

$5.06

$265

6/30/12

Phase I and Phase I / II Clinical Trials

SB-728-T (PatientDerived Tcells Genetically Modified at CCR5 Gene by Zinc Finger Nucleases or ZFNs)

ClinicalTrials.gov ID NCT01252641 w/ final results expected during 2H12 for P1/2 trial in HIV infected subjects not receiving HAART treatment, reported positive prelim data from Phase I trial on 2/28/11 in HIV infected pts receiving treatment w/ HAART, ClinicalTrials.gov ID NCT01044654 w/ final results expected mid-2012

7/28/11

Sangamo BioSciences SGMO

$5.06

$265

Phase 2b (SB509-901) 12/31/11 Clinical Trial

In JAN 2011, completed pt enrlmt in P2B trial for SB-509 Zinc moderately severe diabetic Finger neuropathy and expects to Therapeutic report results during 4Q11, for Gene ClinicalTrials.gov ID Regulation NCT01079325

7/28/11

SanofiAventis

SNY

$34.63

$92,959

Alemtuzuma b (humanized monoclonal antibody Pivotal Phase 3 targeting (CARE-MS II) CD52 on T 12/31/11 Clinical Trial & B cells)

On 7/11/11, reported first of two pivotal P3 trials (CAREMS I) met one of two primary endpts w/ second P3 trial results expected during 4Q11 and regulatory approval filings in US and EU expected during early 2012for pts w/ multiple sclerosis (MS) 7/11/11

Santarus

SNTS

$3.05

$184

Held pre-NDA mtg w/ FDA in late MAY 2011 and plans to Budesonide submit NDA by yr-end 2011, MMX (local- seeking approval for the acting, oral induction of remission of mild FDA New Filing tablet or moderate active ulcerative 12/31/11 (NDA) formulation) colitis

8/4/11

Santarus

SNTS

$3.05

$184

9/30/12

Pivotal Phase 3b Clinical Trial to Support FDA New Filing (BLA) under SPA

RHUCIN (human C1 esterase inhibitor)

In FEB 2011 received refusal to file letter from FDA for BLA seeking approval for treatment of acute attacks of hereditary angioedema, approved in Europe OCT 2010, began Phase 3b study FEB 2011 and expects to complete by 3Q12 to support potential new BLA filing w/ SPA agmt announced in AUG 2011 Being evaluated for treatment of travelers diarrhea in two P3 trials, ClinicalTrials.gov ID NCT01142089 w/ results expected 2H11, ClinicalTrials.gov ID NCT01208922 w/ results expected 4Q11

8/4/11

Santarus

SNTS

$3.05

$184

Phase 3 Clinical Rifamycin 12/31/11 Trials SV MMX

8/4/11

Sanuwave Health

SNWV

$3.10

$65

6/30/12

FDA Decision (PMA)

On 7/6/11, announced PMA submission to FDA, seeking marketing clearance for noninvasive medical device for the treatment of diabetic foot ulcers based on 24-week pivotal trial results in 206 pts, estimated FDA decision mid2012 but no formal decision dermaPACE deadlines for PMA filings In JAN 2011, enrolled first pt in P2b trial for prevention of oral mucositis (OM) (a common side effect of chemo and radiation treatments for head and neck cancer) ClinicalTrials.gov ID NCT01247246 w/ results expected mid-2012

7/6/11

SciClone Pharma

SCLN

$4.23

$247

6/30/12

Phase 2b Clinical Trial

SCV-07 (gamma-Dglutamyl-Ltryptophan)

6/20/11

Sequenom

SQNM

$5.47

$543

Validation Clinical Trial for Trisomy 21 (T21) (Down Syndrome) Laboratory DevelopedTest 12/31/11 (LDT)

MaterniT21 (noninvasive trisomy 21 labdeveloped test)

Expected submission (3Q11) and publication (4Q11) of LDT clinical validation study results to support expected launch during 4Q11-1Q12 for noninvasive blood test to detect chromosome 21 (associated w/ fetal Down syndrome), also developing in-vitro diagnostic (IVD) device w/ expected FDA new filing (PMA) during 4Q121Q13 On 6/28/11, announced start of P2 trial for HFMD vaccine candidate, expects to complete study in six months (1Q12 estimate for results) to support start of P3 trial in spring 2012 during HFMD outbreak season

8/5/11

Sinovac Biotech

SVA

$2.53

$138

3/31/12

EV71 (Enterovirus 71) Vaccine (Hand, Foot and Mouth Phase 2 Clinical Disease or Trial HFMD)

6/29/11

Soligenix

SNGX

$0.26

$57

3/31/12

Phase 1b Clinical Trial

In NOV 2010, completed pt enrlmt w/ prelim results indicating no safety concerns, will assess immune response duration one year after vaccination, ClinicalTrials.gov ID NCT00812071 w/ results RiVax (ricin expected during 1Q12, toxin subreceived FDA Orphan Drug unit vaccine) Status in JAN 2011

6/20/11

Soligenix

SNGX

$0.26

$57

Pivotal Confirmatory Phase 3 (SUPPORTS) Clinical Trial 12/31/11 under SPA

On 7/28/11, announced expanded ptnshp w/ SigmaorBec (oral Tau into Europe w/ $5M beclomethas upfront and $11M potential one milestone pmts plus 40% dipropionate royalty / manufacturing supply or BDP) (a agmt, expects to complete steroid ongoing confirmatory pivotal formulated P3 trial during 2H11 for for local treatment of acute effect in the gastrointestinal (GI) graft vs. GI tract) host disease

7/28/11

Spectranetic s SPNC

$5.52

$185

3/31/13

In JUN 2011, announced first pt enrolled in trial to compare excimer laser atherectomy in conjunction with balloon angioplasty vs. balloon angioplasty alone in the Turbo Elite treatment of above-knee Laser and peripheral artery in-stent Turbo restenosis, ClinicalTrials.gov Tandem ID NCT01330628 w/ results Pivotal Phase II / Laser Guide expected 1Q13 to support potential FDA 510(k) III (EXCITE-ISR) Catheters Clinical Trial submission

7/19/11

Spectrum Pharma

SPPI

$8.13

$432

FDA Decision (Prior Approval 11/20/11 Supplement)

On 3/22/11, announced FDA accepted prior approval supplement w/ expected decision by 11/20/11 to ZEVALIN remove bio-scan (ibritumoma requirement as part of b tiuxetan) treatment regimen for nonInjection Hodgkins lymphoma (NHL)

3/22/11

Spectrum Pharma

SPPI

$8.13

$432

On 3/28/11, passed interim safety and futility analysis (45 Belinostat pts dosed) for pivotal P2 trial (PXD101) (a for Peripheral T-Cell novel Lymphoma (PTCL), expects to histone complete enrlmt of 100 pts in deacetylase 2011 and file NDA in 2012, in or HDAC DEC 2010 completed enrlmt inhibitor anti- in Phase 2 trial for carcinoma Phase 2 Clinical cancer of unknown primary origin w/ 12/31/11 Trials agent) results expected during 2H11 For the treatment of nonmuscle invasive bladder cancer, licensed to AGN, Phase 3 top-line data expected in 2012 (1H12 estimate) to support potential NDA filing in 2012, ClinicalTrials.gov IDs Pivotal Phase 3 EOquin (apa- NCT00598806 & ziquone) NCT00461591 Clinical Trials In MAR 2011, began trial in Switzerland for pts w/ chronic spinal cord injury, expects to enroll and dose first group of pts in 2011, ClinicalTrials.gov ID NCT01321333

5/4/11

Spectrum Pharma

SPPI

$8.13

$432

6/30/12

4/28/11

StemCells

STEM

$2.29

$32

Phase I / II 12/31/11 Clinical Trial

HuCNS-SC (purified human neural stem cells)

7/29/11

StemCells

STEM

$2.29

$32

6/30/12

In FEB 2011, completed pt enrlmt and dosed final (fourth) HuCNS-SC pt for treatment of nerve (purified myelination disorder (PMD) in human children, ClinicalTrials.gov ID Phase I Clinical neural stem NCT01005004 w/ results Trial cells) expected during 1H12 7/29/11

Sucampo Pharma

SCMP

$3.13

$131

6/30/12

Europe and Japan New Drug Approval Decisions

In SEP 2010 submitted NDA for approval in Japan w/ estimated decision during 2H11, in AUG 2011 submitted MAA to MHRA seeking UK approval for treatment of chronic idiopathic constipation AMITIZA (CIC) w/ estimated decision (lubiproston w/in one year (3Q12 estimate), already FDA approved 8/5/11 e)

Sucampo Pharma

SCMP

$3.13

$131

Has completed enrlmt in ongoing P3 trial for opioid induced bowel dysfunction (OBD) w/ top-line results AMITIZA expected by yr-end 2011 to Pivotal Phase 3 (lubiproston support potential NDA filing 12/31/11 Clinical Trial e) during 1H12

8/5/11

Sunesis Pharma

SNSS

$1.36

$64

6/30/12

In DEC 2010, first pt dosed in pivotal P3 trial in combo w/ cytarabine for pts w/ first relapsed or refractory acute Vosaroxin myeloid leukemia (AML), (formerly expects interim analysis by data safety monitrg board in voreloxin) Pivotal Phase 3 (anti-cancer mid-2012, ClinicalTrials.gov (VALOR) quinolone ID NCT01191801 w/ final Clinical Trial derivative) results expected during 1H13

7/20/11

Synta Pharma

SNTA

$3.88

$192

6/30/12

Elesclomol (programmed cell Phase I and II death / Clinical Trials, apoptosis Pending Phase anti-cancer 2b Clinical Trial agent) Ganetespib (formerly STA-9090) (Hsp90 inhibitor anticancer agent)

In FEB 2011, first pt treated in single-agent P1 trial for acute myeloid leukemia (AML) w/ ClinicalTrials.gov ID NCT01280786, ClinicalTrials.gov ID NCT00888615 for P2 ovarian cancer trial in combo w/ paclitaxel w/ results expected during 1H12 for both trials, expects to begin P2B trial for lung cancer in 2011 On 7/20/11, treated first pt in P2B/3 trial in combo w/ docetaxel for non-small cell lung cancer (NSCLC) and expects to report interim results in early 2012 (1Q12 estimate)

7/20/11

Synta Pharma

SNTA

$3.88

$192

3/31/12

Phase 2b / 3 (GALAXY) Clinical Trial

7/20/11

Talon Therapeutic s (formerly Hana Biosciences) TLON

$0.97

$21

9/19/11

On 8/29/11, reached SPA agmt w/ FDA for planned P3 trial by yr-end 2011 in pts w/ FDA Reply to acute lymphoblastic leukemia Accept NDA (ALL), on 7/18/11 announced Filing and Issue MARQIBO NDA filing seeking PDUFA (Optisome accelerated FDA approval for Decision Date, encapsulate treatment of adults w/ Pending d Philadelphia Chromosome Confirmatory formulation Negative ALL w/ expected Phase 3 of approved FDA reply by 9/19/11 to (HALLMARQ) cancer drug accept NDA filing and issue Clinical Trial vincristine) decision date

8/29/11

Targacept

TRGT

$15.60

$521

TC-5214 (a nicotinic Pivotal Phase 3 channel 12/31/11 Clinical Trials blocker)

Partnered with AZN for add-on depression treatment for nonresponders to first-line therapy, ClinicalTrials.gov IDs NCT01180400, NCT01153347, NCT01157078, and NCT01197508 w/ results expected during 4Q11-1Q12, began P2b trial as switch mono-therapy for nonresponders, planned NDA filing during 2H12 6/21/11

Tekmira Pharma

TKMR

$2.01

$23

In DEC 2010, began dosing patients for lead anti-cancer RNA interference (RNAi) candidate, expects to enroll up to 52 pts w/ advanced solid TKM-PLK1 tumors, ClinicalTrials.gov ID (cell cycle NCT01262235 w/ final results protein anti- expected during 3Q12, expects to report interim Phase I Clinical cancer 12/31/11 Trial agent) results by yr-end 2011

8/9/11

Tekmira Pharma

TKMR

$2.01

$23

In AUG 2011 partner ALNY announced plans to present ALN-TTR01 data at scientific mtg Nov. 20(systemic 22 in Japan from ongoing P1 RNA trial in up to 28 pts w/ interference amyloidosis (condition that or RNAi damages peripheral nerves therapeutic and heart), TKMR developed Phase I Clinical for RNAi drug delivery tech for 11/20/11 Trial amyloidosis) this compound

8/2/11

Tengion

TNGN

$0.80

$19

As of AUG 2011, has enrolled and implanted 3 pts in ongoing P1 trial designed to regenerate bladder tissue in pts w/ bladder cancer, Neo-Urinary proposed surgical Conduit modifications to FDA w/ (patientinterim update on trial status derived cells expected during 4Q11, w/ bioClinicalTrials.gov ID Phase I Clinical absorbable NCT01087697 w/ results 12/31/11 Trial scaffold) expected during 1H13

8/29/11

Theravance THRX

$17.43

$1,477

9/30/12

GSK573719 / Vilanterol ('719 / VI) (Dual Pivotal Phase 3 Bronchodilat Clinical Trials or Inhaler)

Expects to enroll over 5,000 pts w/ the lung condition chronic obstructive pulmonary disease (COPD) in seven P3 trials w/ results expected mid2012 (2-3Q12 estimate), partnered w/ GSK

7/29/11

Theravance THRX

$17.43

$1,477

RELOVAIR (fluticasone and vilanterol) (once-daily inhaled steroid + long-acting Pivotal Phase 3 beta 12/31/11 Clinical Trials agonist)

Ongoing pivotal P3 trials for chronic obstructive pulmonary disease (COPD) and asthma fully enrolled (11,000 pts) w/ results expected by late 2011early 2012, partnered w/ GSK 7/29/11 Partner Fenwal continues to advance the registration process for these cord blood processing & storage products in China w/ expected approvals in China (SFDA) during 2H11

ThermoGenesis

KOOL

$1.58

$26

SFDA (China) 12/31/11 Decisions

BioArchive System & AXP Platform

5/6/11

Threshold Pharma

THLD

$1.53

$75

9/30/11

In FEB 2011 announced SPA agmt w/ FDA for design of TH-302 (a pivotal P3 trial for pts w/ advanced / metastatic unhypoxiaactivated pro- removable soft tissue sarcoma Pending Pivotal drug or HAP in combo w/ doxorubicin that Phase 3 Clinical anti-cancer is expected to begin during Trial under SPA agent) 3Q11 7/25/11

Threshold Pharma

THLD

$1.53

$75

Phase I and II 12/31/11 Clinical Trials

On 7/25/11, announced start of trial in combo w/ AVASTIN for pts w/ recurrent brain cancer (glioma), in JUN 2011 began P1/2 trial in combo w/ SUTENT for variety of cancers w/ ClinicalTrials.gov ID NCT01381822 (results TH-302 (a expected mid-2013), P1 hypoxiaactivated pro- leukemia (NCT01149915) and drug or HAP P2 pancreatic cancer anti-cancer (NCT01144455) trial results agent) expected 2H11 7/25/11

Titan Pharma

TTNP

$1.50

$89

Probuphine (subcutaneo us, Phase 3 Open implantable Label Safety delivery of Clinical Trial, buprenFDA New Filing orphine over 12/31/11 505(b)(2) NDA six months)

Pre-NDA mtg w/ FDA planned for 10/25/11 to discuss 505(b)(2) NDA filing based on confirmatory P3 trial that met primary endpt for treatment of pts w/ opiate addiction, expects to report open-label safety study results by yr-end 2011 8/31/11

Transcept Pharma

TSPT

$2.75

$37

TO-2061 (low-dose ondansetron formulation) (ondansetro n (0.5mg Phase 2 Clinical and 0.75mg 12/31/12 Trial doses)

On 3/14/11, began trial for treatment of obsessive compulsive disorder (OCD) pts w/ inadequate response to first-line treatments, expects to enroll approx. 150 pts, ClinicalTrials.gov ID NCT01275248 w/ results expected during 3-4Q12 7/13/11

Tranzyme Pharma

TZYM

$3.13

$74

6/30/12

In FEB & MAR 2011, began two pivotal P3 trials for postoperative ileus (a temporary halt of normal bowel motility after surgery) in hospital and Ulimorelin acute care settings, expects to Pivotal Phase 3 (intravenous complete both studies during (ULISES 007 GI pro1H12, ClinicalTrials.gov IDs and 008) motility NCT01285570 & Clinical Trials agent) NCT01296620 8/12/11

Trius Therapeutic s TSRX

$6.11

$174

3/31/12

Pivotal Phase 3 Torezolid Clinical Trials Phosphate under SPA (TR-701)

On 8/5/11, announced SPA agmt for second planned P3 trial (expects to begin 4Q11) for IV and oral dosage forms for treatment of acute bacterial skin and skin structure infections (ABSSSI), ClinicalTrials.gov ID NCT01170221 for ongoing P3 trial expected to complete enrlmt yr-end 2011 w/ results expected early 2012 (1Q12 estimate)

8/5/11

Unigene

UGNE

$0.90

$84

In APR 2011, completed pt enrlmt in ongoing P2 trial for oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women, expects to report top-line results by year-end 2011, ClinicalTrials.gov ID NCT01321723, in AUG 2011 announced up to $2.2M Oral PTH Phase 2 Clinical (para-thyroid milestone pmts from partner hormone) GSK as part of supply agmt 12/31/11 Trial

8/8/11

Unigene

UGNE

$0.90

$84

FDA New Filing (NDA) (4Q11), Phase 2 Clinical Oral 12/31/11 Trial (1Q12) Calcitonin

Licensed to Tarsa Therapeutics (private) for novel oral formulation of calcitonin (currently marketed as nasal spray) for postmenopausal osteoporosis, reported positive results in pivotal trial w/ SPA agmt in MAR 2011 and plans to submit NDA by late 2011, in JUL 2011 completed enrlmt in P2 trial w/ interim data expected in early 2012 (1Q12 estimate)

7/12/11

United Therapeutic s UTHR

$42.80

$2,496

6/30/12

On 8/24/11, reported second of two pivotal P3 trials did not meet endpt for treatment of pulmonary arterial hypertension (PAH) but plans Oral to file NDA during 1H12 based Treprostinil on results in previous P3 trial (injected in treatment-nave pts plus version drug is already FDA approved FDA New Filing approved as for PAH by IV, inhaled and (NDA) Remodulin) subcutaneous routes 8/24/11 Expects to begin trial in pts w/ Major Depressive Disorder Tasimelteon (MDD) during 2H11 compared (VEC-162) to placebo w/ an 8-week (melatonin treatment and optional openagonist) label extension period 3/31/11

Vanda Pharma

VNDA

$5.61

$158

Pending Phase 2b / 3 Clinical 12/31/11 Trial

Vanda Pharma

VNDA

$5.61

$158

6/30/12

In AUG 2010, began study for treatment of circadian rhythm sleep disorders, received Orphan Drug status Jan. 2010 for Non-24-Hour Sleep/Wake Tasimelteon Disorder (N24SWD) in blind (VEC-162) individuals, ClinicalTrials.gov Pivotal Phase 3 (melatonin ID NCT01163032 w/ top-line Clinical Trial agonist) results expected during 1H12

6/2/11

Ventrus Biosciences VTUS

$9.40

$117

6/30/12

Ongoing P3 trial in Europe by licensing partner SLA Pharma w/ results expected during 2Q12, expects to complete formulation program by 2Q12 and conduct either one addtl P3 trial in US w/ existing formulation being studied in Diltiazem Europe or two P3 trials in US Topical Cream (VEN w/ the new formulation to support planned NDA filing in Pivotal Phase 3 307) 2013 Clinical Trial In AUG 2011, opened enrlmt for first of two planned pivotal P3 trials for treatment of symptomatic hemorrhoids, expects to report top-line data during 1Q12, ClinicalTrials.gov ID NCT01355874

8/16/11

Ventrus Biosciences VTUS

$9.40

$117

3/31/12

Pending Pivotal Phase 3 Clinical Trial w/ SPA Request

Iferanserin Topical Ointment (VEN 309)

8/16/11

Vermillion

VRML

$2.40

$36

9/30/11

On 8/1/11, announced noticed of allowance for patent VASCLIR covering biomarkers for PAD, Intended-Use Peripheral expects to report top-line data Population Artery during 3Q11 to provide a Clinical Trial Disease finalized biomarker algorithm (Diagnostic Test (PAD) Blood for blood diagnostic test to Evaluation) Test stratify risk of developing PAD

8/1/11

Vertex Pharma

VRTX

$45.52

$9,472

In MAY 2011, received FDA approval for treatment of genotype 1 chronic hepatitis C virus (HCV) infection, has MAA / EMA completed enrlmt in ongoing (Europe) P3B trial to evaluate twicedaily dosing w/ results Decision, Pivotal INCIVEK Phase 3b (Telaprevir) expected as early as 2H12 to (OPTIMIZE) (VX-950 or support potential sNDA filing Clinical Trial to TVR) (HCV by year-end 2012, positive Support sNDA protease opinion adopted by EMA w/ 12/31/12 New Filing inhibitor) expected EU approval 3Q11 7/29/11

Vertex Pharma

VRTX

$45.52

$9,472

6/30/12

On 7/26/11, announced interim results in combo w/ VX222 (experimental polymerase inhibitor) for treatment of HCV and expects to report data from all-oral treatment arms Phase 2 INCIVEK during 1H12, expects to begin (ZENITH) (Telaprevir) P3 trial during 2H11 in combo Clinical Trial, (VX-950 or w/ pegylated-interferon and Pending Pivotal TVR) (HCV ribavirin in people co-infected Phase 3 Clinical protease with HCV and HIV to support Trial inhibitor) sNDA filing 7/26/11

Vertex Pharma

VRTX

$45.52

$9,472

VX-770 (Cystic Fibrosis Transmembrane FDA and MAA / ConductEMA New ance 10/31/11 Filings Regulator)

In MAR 2011, reported positive results for oral treatment for cystic fibrosis (CF) from 24-week analysis of P3 ENVISION trial and in JUN 2011 positive P3 final STRIVE trial results to support planned regulatory approval filings in US and Europe in OCT 2011 7/29/11

Vical

VICL

$3.41

$245

6/30/12

Pending Phase 3 Clinical Trial

On 7/14/11, announced exclusive license agmt w/ Astellas Pharma, includes $130M upfront plus milestone pmts (w/ $35M due near-term) and double-digit royalties, expects to begin pivotal P3 trial for immune compromised stem cell transplant pts and TransVax P2 trial for solid organ CMV transplant pts for Therapeutic Cytomegalovirus (CMV) Vaccine infection during 1H12 7/15/11

Vical

VICL

$3.41

$245

Pending Phase 12/31/11 3 Clinical Trial

Collategene (gene-based blood vessel growth factor)

Partner AnGes expected to begin P3 trial by yr-end 2011 for the treatment of advanced peripheral artery disease (PAD)

6/22/11

Vical

VICL

$3.41

$245

6/30/12

Expects to complete treatment and follow-up in ongoing pivotal P3 trial for pts w/ Allovectin-7 metastatic melanoma in FEB Pivotal Phase 3 (gene-based 2012 w/ top-line results Clinical Trial therapeutic expected during 2Q12, (AIMM) under cancer ClinicalTrials.gov ID SPA vaccine) NCT00395070

8/3/11

Vivus

VVUS

$8.17

$670

Observational (FORTRESS) Study to Support FDA Resubmission (NDA), MAA / 12/31/11 EMA Decision

QNEXA (phentermin e plus topiramate) (controlledrelease, once-daily capsules) Avanafil (an oral phosphodiesterase type 5 or PDE5 inhibitor)

Expects to report retrospective fetal outcomes study following topiramate exposure to assess birth defect risk during 4Q11 to support planned NDA resubmission and response to MAA / EMA (EU approval) 120day questions during 4Q11 8/2/11 On 9/1/11, announced FDA accepted NDA for standard 10month review w/ PDUFA decision goal date of 4/29/12, seeking approval for treatment of erectile dysfunction (ED) 9/1/11

Vivus

VVUS

$8.17

$670

4/29/12

FDA Decision (NDA)

XenoPort

XNPT

$6.68

$237

In APR 2011 received FDA approval along w/ US partner GSK for Restless Legs Syndrome in adults, expected PMDA decision during 2H11 w/ partner Astellas Pharma, HORIZANT sNDA filed on 8/9/11 by GSK (gabapentin seeking approval for treatment PMDA Decision enacarbil) of post-herpetic neuralgia w/ (Japan) (2H11), Extendedexpected decision by 6/9/12 FDA Decision Release under standard 10-month 12/31/11 (sNDA) (6/9/12) Tablets review period 8/10/11 XP21279 (novel formulation converted into L-Dopa / dopamine) ClinicalTrials.gov ID NCT01171313 for ongoing P2B trial in combo w/ levodopa in pts w/ Parkinsons disease, expects to report topline results by yr-end 2011

XenoPort

XNPT

$6.68

$237

Phase 2b 12/31/11 Clinical Trial

8/4/11

XenoPort

XNPT

$6.68

$237

9/30/12

Arbaclofen Pivotal Phase 3 Placarbil Clinical Trial (AP) under SPA (XP19986)

ClinicalTrials.gov ID NCT01359566 w/ results expected during 3Q12 for pivotal P3 trial for treatment of spasticity in multiple sclerosis (MS) pts to support potential NDA 505(b)(2) filing as a new formulation of approved muscle relaxant drug baclofen

8/4/11

22nd Century

XXII

$1.20

$33

Phase 2b 11/30/11 Clinical Trial

On 8/8/11, first pts enrolled in P2B trial for smoking cessation aid product X-22 (very candidate, expects FDA low nicotine decision on Fast Track status / VLN by SEP 2011, expects to cigarettes report results from trial in late smoking NOV 2011 (four wks of cessation continuous smoking cessation aid) after program)

8/9/11

YM BioSciences YMI

$1.87

$206

Phase 2 and 3 12/31/11 Clinical Trials

Japan licensee Daiichi Sankyo has submitted to present lung Nimotuzuma cancer data during 2H11, P2 trial for treatment of brain b (humanized cancer in children (glioma) has completed enrlmt w/ epidermal results expected 2H11, EU growth partner Oncoscience enrolling factor, pts for P2b/3 pancreatic EGFRcancer trial (ClinicalTrials.gov targeting monoclonal ID NCT00561990) w/ results expected mid-2012 8/24/11 antibody)

YM BioSciences YMI

$1.87

$206

Phase I / II Clinical Trial, Pending Phase 12/10/11 2 Clinical Trial

On 6/3/11 reported interim data w/ 46% spleen response and 50% anemia response, completed enrlmt in MAY 2011 w/ full data expected during 4Q11 at ASH mtg Dec. 10-13 for treatment of myelofibrosis, expects to CYT387 (a begin 60-pt P2 twice-daily JAK1 / JAK2 dosing (BID) trial during 3Q11 Kinase to support start of pivotal P3 Inhibitor) trial in 1H12

8/1/11

YM BioSciences YMI

$1.87

$206

Phase Ib / II 12/31/11 Clinical Trial

CYT997 (a small molecule vascular disrupting agent or VDA)

Expects to report preliminary data from ongoing trial in brain cancer (glioma) pts in combo w/ carboplatin during 2H11, ClinicalTrials.gov ID NCT00650949, pt enrlmt has closed for this trial 5/12/11

Zalicus (formerly CombinatoRx) ZLCS

$1.43

$142

Phase 2b (SYNERGY) 12/31/12 Clinical Trial

On 6/29/11, announced start of P2B trial in pts w/ rheumatoid arthritis w/ top-line SYNAVIVE results expected during 2H12, novel formulation of two (Z-102) (Dipyridamol marketed drugs w/ patent e and protection thru 2028 being prednisolon compared to placebo (primary e once-daily, objective) and the two drugs modifiedgiven independently release (secondary objective), combo ClinicalTrials.gov ID capsule) NCT01369745 6/29/11

Ziopharm Oncology

ZIOP

$5.06

$346

Expects to begin two-stage potential pivotal trial in late ZINAPAR 2011 (4Q11) for treatment of (Darinarelapsed peripheral T-cell parsin or lymphoma (PTCL), oral ZIO-101) formulation being studied in (organic P1 trial for solid tumors, arsenic anti- ClinicalTrials.gov ID Phase I Clinical cancer NCT01139346 w/ results 12/31/11 Trial agent) expected during 2H11 Indibulin (ZybulinTM or ZIO-301) (oral tubulin binding anticancer agent)

6/10/11

Ziopharm Oncology

ZIOP

$5.06

$346

Phase I / II 12/31/11 Clinical Trial

Being evaluated in patients w/ metastatic breast cancer w/ ClinicalTrials.gov ID NCT01113970 and results expected during 4Q11

6/10/11

Ziopharm Oncology

ZIOP

$5.06

$346

On 7/19/10, announced initiation of pivotal study for front-line metastatic soft tissue sarcoma w/ ClinicalTrials.gov ZYMAFOS ID NCT01168791 and results Pivotal Phase 3 (Palifosexpected during 2H12, began (PICASSO III) famide) (ZIO- Phase I study for small cell 12/31/12 Clinical Trial 201) lung cancer in DEC 2010 6/10/11

Zogenix

ZGNX

$3.28

$112

3/31/12

ZOHYDRO (hydrocodon e extendedrelease capsules) FDA New Filing (previously (NDA) ZX002)

On 8/17/11 reported pivotal P3 trial for treatment of moderate to severe pain met primary and secondary enpts to support planned NDA filing early 2012 (1Q12 estimate), expects to finish long-term safety study during 3Q11

8/17/11