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Biopartners Withdrew the Application for Marketing Authorisation for Biferonex® - The European Medicines Agency has been formally notified by BioPartners GmbH of its decision to withdraw the application for a centralised marketing authorisation for Biferonex
Biopartners Withdrew the Application for Marketing Authorisation for Biferonex®

 

NewswireToday - /newswire/ - Baar, Switzerland, 2009/06/01 - The European Medicines Agency has been formally notified by BioPartners GmbH of its decision to withdraw the application for a centralised marketing authorisation for Biferonex.

   
 
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The European Medicines Agency has been formally notified by BioPartners GmbH of its decision to withdraw the application for a centralised marketing authorisation for Biferonex (interferon beta 1a), 6MIU, solution for injection in prefilled syringes.

Biferonex is developed to treat adults with relapsing-remitting multiple sclerosis.

The application for the marketing authorisation for Biferonex was submitted to the Agency in July 2007. On 19 February 2009, the Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the non-granting of the marketing authorisation. Following this, the company requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal.
This decision was taken because the CHMP considered the benefit not to be sufficiently established by the submitted data.

In the view of Biopartners, the data in place are substantial and the body of evidence is strong in support of the products safety and efficacy. A positive risk/benefit profile is adequately established and it is very much comparable to the one known from the other interferon beta products approved in the EU for treatment of relapsing-remitting multiple sclerosis.

Biopartners reserve the right to make further submissions at a future date in this or other therapeutic indication(s).

For further information on Biopartners please contact:
Marie-Joëlle Gaufrès, Head of Commercial Operations
E: marie-joelle[.]Biopartners.ch
P: +41 (0)41 766 20 80

About Biopartners GmbH
Headquartered in Baar, Switzerland, with an affiliate in Germany, Biopartners (biopartners.ch) 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 comprehensive range of biopharmaceutical products that may offer clinically relevant therapeutic benefits across several therapeutic areas.

About the Bioton Group S.A.
Bioton S.A. has a portfolio of 32 products – among them the key product: Recombinant Human Insulin. The company’s intention is to systematically increase the share of medicinal products based on the substances produced via biosynthesis. The introduction of recombinant human insulin enabled Bioton S.A. to join the small group of companies in the world that manufacture this substance. Bioton S.A. aims to continuously develop an attractive portfolio that will include high-margin products of a high therapeutic efficacy.

 
 
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Biopartners Withdrew the Application for Marketing Authorisation for Biferonex®

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