Biogen Idec (BIIB) recently received EU approval for Avonex Pen, which is a single-use intramuscular auto-injector. Approval has been granted for the use of Avonex Pen in patients with relapsing multiple sclerosis (MS) and patients who have had a single demyelinating event.
The approval doesn’t come as a surprise as in April, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending the approval of Avonex Pen.
Avonex Pen has been designed to improve convenience of administration of once-weekly Avonex (interferon beta-1a). Data show that Avonex Pen reduces injection pain and injection anxiety compared to manual injection. Avonex Pen’s convenience of administration could improve patient independence and reduce injection anxiety.
Results from a phase IIIb open-label multi-center study showed that the overall success rate for MS patients using Avonex Pen was 89% with 94% of the patients in the study expressing their preference for Avonex Pen (compared to the Avonex Prefilled Syringe).
Avonex Pen should be available across several European countries in the coming weeks. It is also approved in Canada. As far as US approval is concerned, Biogen has submitted additional information as requested by the Food and Drug Administration (FDA). The company expects approval in the first half of 2012.
Avonex and Tysabri are the leading products in Biogen’s multiple sclerosis franchise. However, competition in the multiple sclerosis market has intensified with the entry of Novartis’ (NVS) Gilenya. We remain concerned that being the first oral treatment to have gained US approval for the treatment of MS, Gilenya could take share from Biogen’s MS products.
Neutral on Biogen
We currently have a Neutral recommendation on Biogen, which carries a Zacks #3 Rank (short-term Hold rating). Key products, Avonex and Tysabri, should continue contributing significantly to sales.
Meanwhile, the company’s restructuring initiative should help drive the bottom-line. We are also pleased with the company’s intention to streamline its pipeline development and focus on candidates that represent higher potential.
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