SCIENCE,

PEOPLE,
AFFORDABLE
MEDICINES

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

SYNTHON.COM
2

SYNTHON IS A
COMPANY COMMITTED
TO DELIVERING
AFFORDABLE MEDICINES
THROUGH INNOVATIVE
SCIENCE.

SCIENCE-DRIVEN
INNOVATION
Good health and a happy life is something we all rightly aspire
to. We believe everyone on the planet deserves access to
quality healthcare. Finding affordable solutions to todays

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

healthcare challenges demands cutting-edge science, highly

talented and motivated people and - above all - an ability to
innovate.
Innovation and continuous improvement are the heart beat of
our company. Our mission is to make healthcare more
affordable, increasing access to important medicines through
the provision of high-quality small molecule generics, biosimilars
and new molecular entities. To make this happen, we hold
ourselves to the highest standards of scientific and operational
excellence in everything we do from the discovery phase in
R&D through production and to delivery of our products to our

SYNTHON.COM

customers - across every technological platform.

A GROWING,
GLOBAL OPERATION
Our products are currently approved by regulatory agencies
in over 80 countries. We have globally-oriented API or drug
product manufacturing facilities in the Czech Republic,

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

Argentina and Spain. Our U.S. facility is dedicated to GMP

biological manufacturing and our facilities in Mexico and
Chile manufacture and package products for the local markets.
In Chile, our recently opened multi-purpose drug product site
is compliant with local and European GMP standards and
contains highly advanced facilities varying from development
to large-scale production of tablets, capsules and pre-filled
syringes. With our state-of-the-art biopharmaceutical
laboratories and GMP manufacturing facility for production of
antibody-drug conjugates (ADCs) up to Phase III clinical trials
and early launches in our main campus in the Netherlands,
our worldwide infrastructure is fully rigged up, positioning us

SYNTHON.COM

to deliver on our ambitions.

We continue to invest and expand globally and are continually
looking to find partners for our products in all major markets.
Synthons strategy from its inception included development of
a vertically integrated organization. Today, we control every
facet of the development chain beginning with the production
of raw materials through to the manufacture and sale of our
products. This is, and has always been, one of our greatest
strengths in enabling us to deliver high-quality medicines to

the people most in need of them.

SYNTHON.COM

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

OUR
STRATEGY
Synthons ambition is to become a recognized
leader in specialty pharmaceuticals,
focusing on oncology and autoimmune/
neurodegenerative diseases particularly
multiple sclerosis (MS). The vertically
integrated model we developed for small
molecule generics is expanding as we
continuously strive to improve our R&D
capabilities, global regulatory and IP expertise,
and world-class manufacturing and supply
chain operations. And we extended this model
to our newer biosimilar and new biological and
new chemical entity technological platforms.
Our innovative R&D and proven ability to
manufacture and distribute high quality
pharmaceuticals positions us well for our
future in specialty pharmaceuticals.

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

8

SYNTHON.COM

GROWING
R&D CAPABILITIES
Research and development remain vital to the
overall value chain and are essential to our
company. We invest heavily in basic and
applied research and we are focusing our
efforts in the specified core therapeutic areas.
In addition to chemical and (bio)pharmaceutical
R&D, we carry out analytical and clinical
research worldwide. We have our own fully
functional clinical drug development unit which
is well equipped to take our development
phase compounds into clinical trials up to
and including phase III.

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

SYNTHON.COM
10

Small molecule generics continue to form the

backbone of our product portfolio. Our generic
pipeline is rich with research projects and
pending regulatory applications. In the past
year, as in other years, we launched several
products in major markets. In multiple
European countries we brought ibandronate
tablets and injectables for the treatment of
bone cancer and osteoporosis to the market.
We also launched memantine in Germany, with
our customer being the first generic company
to enter the German market. This is a
tremendous achievement and the opportunities
are huge as this is the second largest market
in Europe. Memantine is indicated for the
treatment of patients with moderately severe
to severe Alzheimers disease. Additional
launches include tamsulosin capsules, for the
treatment of benign prostatic hyperplasia;

DISTINCTIVE IN
GENERICS

montelukast, for the treatment of asthma and

allergies; and pramipexole, for patients with
Parkinsons disease - all in the Ukraine.
Further, we hold Certificates of Suitability to
the European Pharmacopoeia (CEP) for our
drug substances pramipexole; zolpidem,
against insomnia; tamsulosin; and letrozole,
for the treatment of breast cancer.
In the United States, we gained tentative
approval for tadalafil (pulmonary arterial
hypertension) and launched pioglitazone
(diabetes). For tadalafil, Synthon is the Single
First Filer and is entitled to 180 days of
Hatch-Waxman exclusivity upon the first
commercial marketing of the generic drug
product. The key highlight in Latin America is
the market approval obtained for our MS
product glatiramer in Argentina.

12

SYNTHON.COM

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

PROMISING
BIOPHARMACEUTICAL
PIPELINE
Synthon started its biopharmaceutical
franchise (the development of biopharmaceutical medicines based on therapeutic
proteins) in 2007. The franchise focuses on
new biological entity development and also
includes biosimilar antibody development.
This highly-innovative business covers a
wide spectrum of technologies, including
complex small molecule chemistries, cell line
development and fermentation, protein
purification, analytics, formulation, and
development of highly innovative biologics.
Our two principal technology platforms are
antibody-drug conjugate (ADC) technology,
comprising a unique linker-drug platform
to generate novel next generation ADC
candidates, and SYNLEXTM, a

plant-based protein expression and production

platform for difficult to express proteins and
engineered antibodies that have functional
advantages over those produced in
conventional platforms.
Our biopharmaceuticals project portfolio is
well positioned to encompass multiple
clinical-stage programs in the coming years
with our first ADC drug candidate entering
the clinic in 2014. We are determined to be
best-in-class with these innovative products.
Our portfolio reflects our focus and
commitment to make medicines for treating
medically complex and serious conditions
(e.g., cancer and multiple sclerosis) more
accessible.

14

SYNTHON.COM

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

We believe in a collaborative model based

upon strong partnerships with leading
scientists, research institutions and partner
companies. Our strategy of developing
robust business-to-business partnerships
enables us to share knowledge with and
draw upon the specialist skills of partner
companies to manage costs, deliver short
product development cycle times and bring
much-needed products to market. Such has
been the success of our efforts that since
2005, the number of partner companies has
jumped from around 60 to almost 200 today.
In terms of partnering our (pre)clinical
biopharmaceutical programs, we are in a
position to choose the optimum commercial
path for each program. We look to partner
a technology or product candidate at an
appropriate pre-market stage or value
inflection point.

STRENGTH THROUGH
COLLABORATIVE
PARTNERSHIPS

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

16

SYNTHON.COM

INTELLECTUAL
PROPERTY
Intellectual property rights will remain a
crucial factor in the pharmaceutical industry.
We actively promote and defend our
interests worldwide, particularly with regard
to patent and regulatory issues. To this end,
we have access to high quality legal
representation and patent attorneys.
By having the right legal expertise at hand,
we can proactively ensure that our interests
are fully protected and a seamless and
effective business operation is maintained.

18

SYNTHON.COM

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

REGULATORY
AFFAIRS
We provide our customers with a complete
product, including all components necessary
for trouble-free registration, wherever in the
world. In practical terms, this means that our
experts are familiar down to the smallest
detail with increasingly stringent and
ever-changing regulatory regimes in more
than 80 countries. We compile registration
files, compliant with the chemical,
pharmaceutical and clinical requirements of
regulatory authorities, such as the EMA, FDA
and TGA. In cases where we out-license a
biopharmaceutical before regulatory
submission, our counterparts can count on
detailed documentation and support that
can eventually be used to build a dossier
for submission.

OUR PRODUCTS

SYNTHON.COM

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

Our products are all high-quality, efficacious

and affordable medicines, often supported
by our own strong patents, guaranteeing a
long product lifespan.

20

* Please note that the reference date for

this Product list is September, 2013.
Our portfolio of approved products differs
from country to country. In addition to the
commercial products mentioned on the
facing page, Synthon owns a rich pipeline
of research projects and pending regulatory
applications for multiple products.

Our global commercial generic portfolio includes*

Allergy
Levocetirizine
Montelukast

Urticaria / allergic rhinitis

Asthma / allergy

tab 5 mg
chewable 4/5 mg; tab 10 mg

Anti-infective
Aciclovir

Anti-viral

tab 200/400/800 mg; lyo 250/500 mg

Cardiovascular
Bisoprolol
Bisoprolol
Dobutamine
Doxazosin
Eplerenone

Simvastatin

Hypertension
HCT Hypertension
Heart Failure
Hypertension / BPH
Heart failure /
left ventricular dysfunction
Hypercholesterolemia

tab 5/10 mg
tab 5+12.5/10+25 mg
inj 12.5 mg/ml - 20 ml
tab 1/2/4/8 mg
tab 25/50 mg
tab 5/10/20/40/80 mg

Central Nervous System

Clozapine
Donepezil
Escitalopram
Flumazenil
Fluvoxamine
Levetiracetam
Memantine
Midazolam
Olanzapine
Paroxetine
Pramipexole
Propofol
Zolpidem
Zopiclone

Schizophrenia
Alzheimer
Depression
Sedation
Depression
Epilepsy
Alzheimer
Anesthetic / Insomnia
Schizophrenia
Depression
Parkinson / RLS
Anesthetic / Sedation
Insomnia
Insomnia

tab 25/50/100 mg
tab 5/10 mg
tab 10/15/20 mg
inj 0.1 mg/ml - 5/10 ml
tab 25/50/100 mg
tab 250/500/750/1000 mg; sol 100mg/ml 150 ml, 300 ml
tab 5/10/15/20 mg
inj 1 mg/ml - 5ml; inj 5 mg/ml - 1/3/10ml
tab 2.5/5/7.5/10 mg
tab 20 mg/drops 20mg/20 drops 20ml flask
tab 0.125/0.25/0.5/1.0/1.5 mg
inj 1%: 20/50/100 ml, 2%: 50ml
tab 5/10 mg
tab 3.75/5/7.5 mg

Oncology
Anastrozole
Bicalutamide
Exemestane
Ibandronate

Letrozole
Ondansetron
Zoledronic acid

Breast cancer
Prostate cancer
Breast cancer
Skeletal events related to
bone metastases
Breast cancer
Nausea after chemotherapy
Skeletal events related
to bone metastases

tab 1 mg
tab 50/150 mg
tab 25 mg

conc.sol 4mg/5ml

Skeletal
Ibandronate
Zoledronic acid
Raloxifen

Osteoporosis
Osteoporosis
Osteoporosis

tab 150 mg, pfs 3mg/3ml

sol 5mg/100ml
tab 60 mg

Urology
Doxazosin
Oxybutynin
Tamsulosin

Hypertension / BPH
Overactive bladder
BPH

tab 1/2/4/8 mg
tab 2.5/5 mg
mr cap 0.4 mg, mr tab 0.4 mg

tab 50 mg, vial 2mg/2ml, 6mg/6ml

tab 2.5 mg
amp 2mg/ml (2ml and 4ml)

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

1991

1993

1994

Founded in The Netherlands

Launched first product:

generic dobutamine

Opened R&D facility in Prague,

the Czech Republic

1997

1998

2000

Opened office in
North Carolina, USA

Acquired drug product

manufacturing facility in Spain

Acquired API production

facility in Blansko,
the Czech Republic

2001

2003

2006

Acquired API production

facility in Argentina

Introduced simvastatin

Introduced tamsulosin

2007

2009

2010

Acquired Laboratorios Rider

in Chile

Opened new R&D and

production unit in the
Czech Republic

Acquired Laboratorios Nafar in

Mexico

_
SYNTHON.COM

Launched biopharmaceuticals
business

2011

_
Opening new biopharmaceutical
lab in Nijmegen,
The Netherlands

Acquired Syntarga in
The Netherlands

Opened office in Moscow,

Russia

Opened office in South Korea

2012

_
Acquisition of LEX System, a biologics manufacturing platform
_
Licensed biosimilar trastuzumab to Amgen/Watson
_
Multi-purpose GMP product manufacturing facility in Chile operational
_
Inauguration of R&D pilot plant in Argentina

22

LEADERSHIP BY
EXAMPLE
Synthon was founded in 1991, and within
two years its creative vision and passion for
making healthcare more affordable led to the
development of dobutamine, a sympathomimetic drug used in the treatment of heart
failure and cardiogenic shock. The success
of this first product out of the blocks led to
rapid international growth. Synthon grew
over the course of its first decade from a
small Nijmegen-based outfit employing less
than a hundred people into a fully-fledged
specialty pharma company with laboratories,
offices and production plants all around the
world.

A headcount of more than 1,400 highly

educated people around the world, strong
profits and a sound financial foundation are
the core ingredients to successfully delivering
what we do best: affordable medicines to
those in need. This would not have been
possible without the right combination of
technical expertise, business discipline and
entrepreneurial capability at every level of
management.

24

SYNTHON.COM

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

A CORE OF
TALENTED PEOPLE
Our success stands or falls with the quality
of our people. Our company is our people.
We arent just content to bring together a
group of talented scientists. We openly seek
people who share the same values and are
both entrepreneurial in attitude and able to
work selflessly as part of a team for the good
of the company and its ambitious goals.
People with the drive to contribute to the
creation of new and effective medicines.
Modern R&D work is multidisciplinary. We want
our scientists and researchers to be able to
see the bigger picture and think outside their
own field of expertise. In a nutshell, we require
people who are willing to share knowledge
with other disciplines, who are prepared to
work hard to produce commercially viable
products, and who are team players. Its a
tall order, but we are well on our way to
creating a sustainable platform for success.

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

GLOBAL PRESENCE

Nijmegen, The Netherlands

Synthon Headquarters
Barcelona, Spain
Synthon Hispania
Blansko and Prague, Czech Republic
Synthon s.r.o.
Research Triangle Park, USA
Synthon Pharmaceuticals, Inc.
San Lorenzo, Argentina
Synthon Argentina S.A.
Santiago, Chile
Laboratorios Rider Ltda
Guadalajara, Mexico
Laboratorios Nafar
Moscow, Russia
Synthon LLC

26

SYNTHON.COM

Seoul, South Korea

Synthon Korea Co. Ltd.

CONTACT
Would you like to learn more about Synthon?
Please visit www.synthon.com
If you are interested in our product portfolio,
please feel free to contact us.

SCIENCE, PEOPLE, AFFORDABLE MEDICINES

Business Development Generics

Businessdevelopment@synthon.com
(+31) 24 37 27 700
Business Development Biopharmaceuticals
Biobusdev@synthon.com
(+31) 24 37 27 700
If you would like to know more about job
opportunities, please visit www.synthon.com
and click on Careers.

Editorial coordination
Synthon Holding BV
Corporate Communications
Nijmegen, The Netherlands

SYNTHON.COM

Design
Zuiderlicht
Maastricht, The Netherlands
Printing
Drukkerij Tesink
Zutphen, The Netherlands
September 2013
Synthon Holding BV

28

www.synthon.com

Disclaimer
Copyright 2013 Synthon Holding BV.
All rights reserved. Reproduction of the
content in other publications is permitted.
However, credit to Synthon would be
appreciated.
This brochure contains information on
pharmaceutical products and has been
composed for healthcare professionals.
It has been composed with the greatest
possible care. It may however contain
inconsistencies and for that reason it
cannot be relied upon. Synthon is not
liable for any consequences as a result
of the reliance on any information
contained in this brochure.