Zacks_Analysts' Blog : Conditional EU Approval for Fampyra - Analyst Blog

Biogen Idec’s (BIIB) Fampyra (prolonged-release fampridine tablets) recently received conditional approval from the European Commission. Fampyra gained conditional approval for improving walking in adult patients with multiple sclerosis (MS) who have walking disability (Expanded Disability Status Scale 4-7).

Fampyra has shown efficacy in people with all types of MS and can be used alone or in combination with disease modifying therapies, including immunomodulatory drugs.

Conditional approval was expected as in May, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) had issued a positive opinion regarding the conditional approval of Fampyra.

As part of the conditional approval, which is renewable annually, Biogen will have to provide additional data on the long-term safety and benefits of Fampyra, especially on Fampyra’s benefits beyond an improvement in walking speed.

Agreement with Acorda

Fampyra is already available in the US, under the trade name Ampyra, where it is being marketed by Acorda Therapeutics (ACOR). Acorda received US Food and Drug Administration approval, in late January 2010, for Ampyra for improving walking speed in patients suffering from MS. Ampyra sales came in at $133.1 million in 2010 and are expected to increase to $205 - $230 million in 2011.

Biogen has a collaboration and license agreement with Acorda for the development and commercialization of products containing fampridine in ex-US markets. Fampyra is approved in Australia for the symptomatic improvement of walking ability in adult multiple sclerosis patients who have shown improvement after eight weeks of treatment. Biogen intends to launch Fampyra across Europe, starting with Germany, from Sep 2011.

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 Biogen’s intention to streamline its pipeline development and focus on candidates that represent higher potential.