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).