Biopartners To Appeal The CHMP's Negative Opinion On Its Novel Interferon Beta-1a

Main Category: Multiple Sclerosis
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 22 Feb 2009 - 1:00 PDT

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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.

About Biferonex

Biferonex is an innovative pH neutral and human serum albumin (HSA) free formulation at physiological osmolarity providing an alternative interferon beta treatment solution for patients suffering from relapsing remitting multiple sclerosis (RRMS).

About the MS market

The World Health Organization estimates that multiple sclerosis affects 2.5 million people worldwide and is one of the most common neurological disorders and causes of disability of young adults, especially in Europe and North America. According to the Datamonitor, the global MS market continues to grow at a steady rate and was estimated to be worth over $5.3 billion in 2007.

Biferonex

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