The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) recently issued a positive opinion regarding the conditional approval of Biogen Idec’s Fampyra. Biogen is seeking approval for the use of Fampyra (fampridine) for improving walking ability in adult patients with multiple sclerosis.
The CHMP’s positive opinion comes as a surprise as earlier this year the committee had recommended against the approval of Fampyra. Biogen had subsequently filed a request asking for a re-examination of the decision.
A final decision from the EU regulatory authorities regarding the conditional approval of Fampyra should be out in 67 days. 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 . Acorda received US Food and Drug Administration approval, in late January 2010, for the marketing of Ampyra in the US for improving walking speed in patients suffering from MS.
Ampyra sales came in at $133.1 million in 2010. Acorda expects Ampyra sales to increase to $205 - $230 million in 2011.
Biogen has a collaboration and license agreement with Acorda (signed in 2009) for the development and commercialization of products containing fampridine in ex-US markets.
Last week, Fampyra gained approval in Australia for the symptomatic improvement of walking ability in adult multiple sclerosis patients who have shown improvement after eight weeks of treatment. European approval will trigger a $25 million milestone payment to Acorda.
Neutral on Biogen
We currently have a Neutral recommendation on Biogen, supported by 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.