Synthon Brochure

8/9/2019 Synthon Brochure

1/17

SCIENCE,

PEOPLE,

AFFORDABLEMEDICINES


2/17

SYNTHON IS A

COMPANY COMMITTED

TO DELIVERINGAFFORDABLE MEDICINES

THROUGH INNOVATIVE

SCIENCE.


3/17

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.


4/17

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.


5/17

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.


6/17

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


7/17

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


8/17


9/17

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


10/17

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


11/17

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


12/17

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.


13/17

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


14/17

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


15/17


16/17

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

[email protected]

(+31) 24 37 27 700

Business Development Biopharmaceuticals

[email protected]

(+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


17/17

Synthon Brochure

Documents

Transcript of Synthon Brochure