Regulatory Approval In Europe Granted For Synthon’s Glatiramer Acetate 40 Mg/Ml

Published: Oct 05, 2017

NIJMEGEN, the Netherlands--(BUSINESS WIRE)--Synthon today announced that it has successfully concluded the decentralized procedures for glatiramer acetate 40 mg/ml pre-filled syringe for the treatment of relapsing forms of multiple sclerosis and received regulatory approval in Europe. Synthon’s three-times-a-week glatiramer acetate is a therapeutically equivalent version of the originator medicine Copaxone®* 40mg.

Synthon received regulatory clearance in all 27 EU/EEA member states involved in the procedures. Granting of national marketing authorizations will follow in the near future.

Synthon’s 20 mg/ml glatiramer acetate product has already received marketing authorizations in these European countries. As of the end of 2016, Synthon's partners have introduced glatiramer acetate 20 mg/ml in the majority of these countries.

“We are very pleased with this approval,” commented Synthon’s chief executive officer Jacques Lemmens. “It allows us to make an affordable version of the 40 mg/ml dosage strength of glatiramer acetate available to MS patients in Europe.”

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About Synthon

Synthon, with headquarters in Nijmegen, the Netherlands, is an international pharmaceutical company and a leader in the field of generic medicines. The company started its biopharmaceutical franchise in 2007 and is building a promising portfolio of next generation medicines. Synthon is developing rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of oncology and auto-immune diseases. Synthon products are currently approved by regulatory agencies in over 90 countries worldwide and marketed through strategic partnerships and – in dedicated areas – through direct sales. Synthon employs about 1,900 staff worldwide, and in 2016 it recorded a turnover of EUR 258 million. For more information, go to www.synthon.com.

About Multiple Sclerosis

Multiple sclerosis (MS) is an unpredictable, often disabling disease of the central nervous system which interrupts the flow of information within the brain, and between the brain and body. Signs and symptoms vary widely, depending upon the amount of damage and which nerves are affected. Symptoms range from numbness and tingling to blindness and paralysis. These problems may come and go or persist and worsen over time. Relapsing remitting multiple sclerosis (RRMS) is the most common form of MS characterized by clear episodes of inflammatory activity known as relapses, followed by remission. RRMS affects approximately 85 percent of newly diagnosed patients.

* Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.

Instinctif Partners
Melanie Toyne Sewell / Gemma Harris
T: +44 207 866 7860
synthon@instinctif.com

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