Biopartners to appeal the CHMP’s negative opinion on its novel interferon beta-1a

Baar, Switzerland 19 February 2009: Biopartners GmbH has announced that it will request a re-assessment from the EMEA in support of its novel interferon beta-1a, Biferonex^®, after receiving a negative opinion from the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP). According to EMEA procedures Biopartners will continue their work to accomplish the registration of Biferonex.

“We are convinced about the strength of our data based on the results of a Phase III trial. This shows that Biferonex demonstrated safety and efficacy profiles comparable to established interferon beta-1a products already on the market”, said Biopartners’ CEO, Jean-Noël Treilles. “We will therefore be working closely with the EMEA to support the newly-appointed rapporteur and co-rapporteur with any additional data that they need during the re-examination of the dossier. We believe that this is a very unique case as Biferonex is a novel formulation of an Interferon beta-1a that has already been approved in 1996 and 1997 in the US and EU”.

Commenting on the decision, Professor O. R. Hommes, Chairman of the European Charcot Foundation which coordinates MS research in Europe said “I look forward to the re-evaluation with interest. Having seen the results of the Phase III trial at key points throughout its development I would welcome Biopartners’ interferon beta-1a as a new alternative therapy in the treatment of multiple sclerosis”.

The re-examination will last approximately 3-4 months.

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