PharmaServ

Consulting

&

Business Services

March 2015
Confidential
Solutions to Pharmaceutical Industry
 INDEX
•Healthcare Spectrum covered

•Services offered

•Expertise

•Case Studies

•Background of PharmaServ

•Management Team Profiles

•Clients worked with

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Healthcare Spectrum covered

•Pharmaceutical intermediates

•Bulk Pharmaceutical & Chemicals/Drug Substances

•Drug products Development for Europe, USA, India and ROW Markets

•Drug Substances & Drug product registrations

•Contract Research & Manufacturing business area

•Clinical Services, Bio-Availability & Bio-Equivalence studies

•Drug Distribution in USA, Canada, Europe & Australia and selected ROW markets

•Talent evaluation in Healthcare space

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Services Offered

•Business Due Diligence

•Evaluation of Business Model
•Validity of projections
•Product detailing
•Industry information
•Technology status and industry comparison
•Cost dynamics
•Market demand and supply potential, pricing dynamics and information
•Compete information
•Peak Potential, Risks
•Advices on de-risking

•Risks associated with the business internal & external

•Product position and scalability and future
•Competitor environment
•Market dynamics

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Services Offered

•Business Assistance
•Assist in product selection based on infrastructure
•Market feasibility studies
•Business strategy
•Relationship guidance with partners/customers
•Establishing international business across markets

•Product acquisition strategies

•API technologies
•Generic products
•Partially developed products
•Product up-gradation
•Site Transfer of products from EU & USA in to India and commercial supplies

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Services Offered

•Product sourcing
•Assistance in identifying suitable GMP suppliers
•Establish cost competitiveness
•GMP history etc
•Provide information about long-term competitiveness based on chemistry
handled at the site, intermediate, starting raw material etc
•Evaluate specifications before source recommendations, ICH compliance etc
•Regular & periodic assistance till product is filed with US FDA/regulatory
bodies and commercial supplies
•Product sourcing from India & China

•Dosage Form development & sourcing for Regulated & ROW Markets
•Partnered with a leading CRO to provide exclusive Drug Development Services
•Exclusive tie-up with a US FDA source for supply of API’s and tailor developed
API’s

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Services Offered

•Product sourcing for Indian companies for Co-Marketing

• Sourced products from EU for Arthritis, Rosehip and Rosehip+Collagen
products into India
• In advanced dialogue with a Danish Company for in-licensing Lite Cast
products for Orthopedic clinics and practices
• In-licensing in final stages for a innovative wound management product
from Germany based on Bovine Serum and clinical trials conducted in EU
• Transaction closed with a South Korean company for a Anti-Arthritis cream
based on Sea minerals

•Dosage Form development & sourcing for Regulated & ROW Markets
•Partnered with a leading CRO to provide exclusive Drug Development Services
•Exclusive tie-up with a US FDA source for supply of API’s and tailor developed
API’s

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Kinedex Health Care Ltd

•Co-Owner of a Indian Branded Dosage Company

•Key areas are Ortho, Gyneacology and Gastroentorology.

•Has access to more than 2500 Doctors and practices
•Has a field force of 120 people
•Launched in 6 states and plans on for All Indian launch by mid 2014
•Current size US$3.1Mil and growth rate of more than 100% year on year
•Exclusive marketing out-fit
•Products in category of life styles and innovative products
•1st time product launches in these 3 categories
•Rosiflex No 1 brand in its category
•Laxovel – No 2 in its category

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Expertise

•Advised several companies ranging from API manufacturers to US generic players

•On board with several companies in assisting in strategic selections, product

acquisitions & rationalization of resources

•Strategic and operational advises offer by PharmServ enabled companies increase

their current businesses by several million dollars

•Servicing API sourcing needs for companies across the world in USA, EU and ROW
markets.

•Excellent relationship with all leading API & dosage manufacturers in India

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Case Studies

•Represented a client in front of US$ 4Billlion Fund and closed a investment

transaction of US$50 Mil in 2007

•Assisted a US generic company in acquiring assets in USA, business value US$65Mil

•Assisted a US generic company in acquiring majority stake in a Indian API company,

transaction value US$5 Mil

•Working on a assignment to set-up a Joint Venture in Parental products space

between a European and Indian company

•Assisted a US corporation is acquiring majority stake in a Biotech, Dermatology and

technology companies

•Niche Products identified, developed an successfully licensed 4 ANDA’s to a Mid-

tier US Generic Company

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PharmaServ Background

•Is set-up by 3 Industry professionals with more than 20 Years of experience in

Health care space in India and Globally

•In existence from year 2004

•Handled consulting assignments for US, EU generic companies and Indian

companies.

•The type of companies include Branded dosage form companies in ROW Markets,
EU & US generic companies, EU API companies, Indian API companies and Indian
CRAMS companies

•Dosage form in-licensing from EU and USA in to India and co-marketing in India

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Management Team profiles

Sameer A Paigankar, has 20 years of experience in Indian Pharmaceutical industry

and has to his credit setting-up a drug discovery center from grass root level (1
molecule already licensed) , set-up a Greenfield API facility (current size US$45Mil),
formulation business. Set-up a niche API and drug development center as his last
assignment before stepping in to PharmaServ. Last position held at Glenmark as
Member of Board.

SVK Murali, has 20 years of experience in the Business development focusing on

generic space. He has been consulting and providing strategic inputs to several
companies in Europe, USA and India for expanding their businesses. Assisted
companies in several investment opportunities in India and US. Last position was at
Zydus Cadila as API Marketing Head

Darshak Shah, has 23 years of experience in global sourcing and has excellent
relationships in China, Europe & USA. Currently looks after the commercial activities
and sourcing needs of the group and also handles the consulting for ROW
companies. Last position held was head Sourcing at Glenmark
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List of Organizations associated for Consulting assignments & other Services
Xellia Pharmaceuticals, Denmark Amneal Pharmaceuticals, USA

Codexis, USA Lab Stein, Central America

Unimark Remedies, India Glochem Industries, India

Sai Life Sciences, India BenVenue Laboratories, USA

X-Gen Pharmaceuticals, USA Akorn Inc, USA

Generic Partners, Australia Ingenus Pharmaceuticals, USA

STADA, Germany PrimegeN, UK

Perinx Pharmaceuticals USA Sterling Labs, USA

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 Details of assignments handled
Organization
• Amneal Pharma, USA
• Codexis, USA
• Xellia, Denmark (NOVo Group)
• Generic Partners, AUS
Nature of Assignment Period
Consultant for product selection, 2006-2013
business strategy, acquisition for
facilities and technologies, was
associated from a size of US$4 Mil
to US$740Mil
Applying enzymatic technologies 2005-2009
in API synthesis and selection of
CMO’s for tecnology transfers etc
Assisted in developing ANDA’s for 2006-2013
First to File P IV’s for US from
CRO’s & CMO’s
Registering products in India
Overall development startegy
Identification of products and 2010 till date
markets and out-licensing ANDA’s
for USA and in-licensing for AUS
and EU Markets
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Organization
• X-Gen Pharma, USA
• SAI Life Sciences, India
• Unimark Remedies, India
• Bedford Pharma, USA
Nature of Assignment Period
Identifying and transferring 2011-2012
technology for injectable products
to India from USA
Set-up niche API business, from 2004- till date
zero level, built a business in
excess of US$10MIl.
Successfully got 4 ANDA’s
developed and licensed out to a
Mid-tier generic company in USA
Assisted in getting API sites US 2004-2013
FDA approved and commenced
API business in USA and EU,
valued at US$35 Mil.
Started ANDA program
In re-structuring the 2008-2013
manufacturing operations, WRT
GMP and product selection
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Organization Nature of Assignment Period

• Ingenus Pharma, USA Assisted in setting up entire R&D 22010-2015

back-up in India for development,
manufacturing, acquisition of site
in Switzerland (Oncology),
product pipeline management
• PrimegeN UK Identification of products for EU 2004- till date
and USA and managing entire
product development and
business startegy

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 Contact

PharmaServ Solutions Ltd

408 - 409, Mahavir Icon,
B- Wing, Plot No. 89- 90,
Sector 15, CBD Belapur
Navi Mumbai-400614, India
Tel: ++91 22 61720000
Fax:+91 22 27573391
Mob: +91 9867160521
Mail:svkmurali@pharmaserv.in

Solutions to Pharmaceutical Industry