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8/9/2019 Synthon Brochure
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SCIENCE,
PEOPLE,
AFFORDABLEMEDICINES
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SYNTHON IS A
COMPANY COMMITTED
TO DELIVERINGAFFORDABLE MEDICINES
THROUGH INNOVATIVE
SCIENCE.
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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
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 ofour 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
customers - across every technological platform.
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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,
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 andcontains 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
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.
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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 qualitypharmaceuticals positions us well for our
future in specialty pharmaceuticals.
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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.
GROWING
R&D CAPABILITIES
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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;
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.
DISTINCTIVE INGENERICS
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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
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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.
INTELLECTUAL
PROPERTY
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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 ourexperts 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.
REGULATORY
AFFAIRS
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Our global commercial generic portfolio includes*
Allergy
Levocetirizi ne Urticaria / allergic rhinitis tab 5 mg
Montelukast Asthma / allergy chewable 4/5 mg; tab 10 mg
Anti-infective
Aciclovir Anti-viral tab 200/400/800 mg; lyo 250/500 mg
Cardiovascular
Bisoprolol Hypertension tab 5/10 mg
Bisoprolol HCT Hypertension tab 5+12.5/10+25 mg
Dobutamine Heart Failure inj 12.5 mg/ml - 20 ml
Doxazosin Hypertension / BPH tab 1/2/4/8 mg
Eplerenone Heart failure /
left ventricular dysfunction tab 25/50 mg
Simvastatin Hypercholesterolem ia tab 5/10/20/ 40/80 mg
Central Nervous SystemClozapine Schizophrenia tab 25/50/100 mg
Donepezil Alzheimer tab 5/10 mg
Escitalopram Depression tab 10/15/20 mg
Flumazenil Sedation inj 0.1 mg/ml - 5/10 ml
Fluvoxamine Depression tab 25/50/100 mg
Levetiracetam Epilepsy tab 250/500/750/1000 mg; sol 100mg/ml 150 ml, 300 ml
Memantine Alzheimer tab 5/10/15/20 mg
Midazolam Anesthetic / Insomnia inj 1 mg/ml - 5ml; inj 5 mg/ml - 1/3/10ml
Olanzapine Schizophrenia tab 2.5/5/7.5/10 mg
Paroxetine Depression tab 20 mg/drops 20mg/20 drops 20ml flask
Pramipexole Parkinson / RLS tab 0.125/0.25/0.5/1.0/1.5 mg
Propofol Anesthetic / Sedation inj 1%: 20/50/100 ml, 2%: 50ml
Zolpidem Insomnia tab 5/10 mg
Zopiclone Insomnia tab 3.75/5/7.5 mg
Oncology
Anastrozole Breast cancer tab 1 mg
Bicalutamide Prostate cancer tab 50/150 mg
Exemestane Breast cancer tab 25 mg
Ibandronate Skeletal events related to
bone metastases tab 50 mg, vial 2mg/2ml, 6mg/6ml
Letrozole Breast cancer tab 2.5 mg
Ondansetron Nausea after chemotherapy amp 2mg/ml (2ml and 4ml)
Zoledronic acid Skeletal events related
to bone metastases conc.sol 4mg/5ml
Skeletal
Ibandronate Osteoporosis tab 150 mg, pfs 3mg/3ml
Zoledronic acid Osteoporosis sol 5mg/100ml
Raloxifen Osteoporosis tab 60 mg
Urology
Doxazosin Hypertension / BPH tab 1/2/4/8 mg
Oxybutynin Overactive bladder tab 2.5/5 mg
Tamsulosin BPH mr cap 0.4 mg, mr tab 0.4 mg
OUR PRODUCTS
Our products are all high-quality, efficacious
and affordable medicines, often supported
by our own strong patents, guaranteeing a
long product lifespan.
* 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.
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1991_Founded in The Netherlands
1997_Opened office in
North Carolina, USA
2001_Acquired API production
facility in Argentina
2007_Acquired Laboratorios Rider
in Chile_Launched biopharmaceuticals
business
2011_Opening new biopharmaceuticallab in Nijmegen,
The Netherlands_Acquired Syntarga in
The Netherlands
1993_Launched first product:
generic dobutamine
1998_Acquired drug product
manufacturing facility in Spain
2003_Introduced simvastatin
2009_Opened new R&D and
production unit in the
Czech Republic_Opened office in Moscow,
Russia
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
1994_Opened R&D facility in Prague,
the Czech Republic
2000_Acquired API production
facility in Blansko,
the Czech Republic
2006_Introduced tamsulosin
2010_
Acquired Laboratorios Nafar in
Mexico_Opened office in South Korea
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 sympatho-
mimetic 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.
LEADERSHIP BY
EXAMPLE
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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 knowledgewith 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.
A CORE OF
TALENTED PEOPLE
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Editorial coordination
Synthon Holding BV
Corporate Communications
Nijmegen, The Netherlands
Design
Zuiderlicht
Maastricht, The Netherlands
Printing
Drukkerij Tesink
Zutphen, The Netherlands
September 2013
Synthon Holding BV
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.
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.
Business Development Generics
(+31) 24 37 27 700
Business Development Biopharmaceuticals
(+31) 24 37 27 700
If you would like to know more about job
opportunities, please visit www.synthon.com
and click on Careers.
CONTACT
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