Biopartners Receives EU Marketing Authorization for Ribavirin Biopartners 200mg Film-Coated Tablets for Chronic Hepatitis C

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Biopartners Receives EU Marketing Authorization for Ribavirin Biopartners 200mg

Film-Coated Tablets for Chronic Hepatitis C

From the PharmaLive.com News Archive - Apr. 08, 2010

BAAR, Switzerland--(BUSINESS WIRE)--Apr 8, 2010 - Biopartners GmbH has announced

that it has received EU marketing authorization from the European Commission for

Ribavirin Biopartners 200mg film-coated tablets. The product is intended for the

treatment of chronic hepatitis C infection as part of a combination regimen with

peginterferon alfa-2b or interferon alfa-2b.

Commenting on the news, Dr Conrad Savoy, Biopartners' CEO said: “We are very

satisfied indeed to have received European marketing authorization for Ribavirin

Biopartners. This approval marks an important milestone, both for Biopartners

and also for European healthcare providers, as it ushers in a new era of lower

cost therapy.” Dr Savoy continued: “The granting of the EU marketing

authorization completes a very efficient and successful review procedure, with

Ribavirin Biopartners receiving a positive opinion from the CHMP in only 8

months. We believe this fast review and approval process underlines the strength

of the data presented.”

The studies submitted in the application dossier demonstrated the appropriate

quality of Ribavirin Biopartners 200mg film-coated tablets and its

bioequivalence with the reference product - Rebetol®.

About Biopartners GmbH

Headquartered in Baar, Switzerland, with an affiliate in Germany, Biopartners is

a global biopharmaceuticals company and a leader in the emerging field of

multi-source biopharmaceuticals. Biopartners' mission is to develop optimized

first generation biopharmaceuticals and second generation innovative

formulations, such as long-acting forms that may improve patient compliance.

Biopartners is developing a range of biopharmaceutical products that may offer

clinically relevant therapeutic benefits across several therapeutic areas.

Biopartners is owned by Bioton Group S.A.

About the Bioton Group S.A.

Headquartered in Warsaw, Poland, a Warsaw Stock Exchange listed company, Bioton

S.A. is among the first four companies worldwide being able to produce

recombinant human insulin. This product is already registered on the most

attractive markets. Bioton is able to pursue its strategic objectives of

protecting Patients' health and improving the quality of their lives by

participating in research and development projects and promoting the expansion

of its product portfolio to deliver to the market most innovative pharmaceutical

products. Bioton Group developed its global position by targeting the most

attractive insulin markets – among them Poland, Russia, Ukraine, China, India

and other Asia Pacific countries. Bioton's aim is to build strong, international

operations focused on sales of insulin and other biotech products, development

of new clinically important drugs and strategic alliances with world's leading

pharmaceutical companies.

Contact: Biopartners

Dr Conrad Savoy, CEO

conrad@...

Phone: +41 (0)41 766 20 80