Biogen Idec (BIIB) announced that Fampyra (fampridine) recently gained approval from the Australian Therapeutic Goods Administration (TGA) for the symptomatic improvement of walking ability in adult multiple sclerosis (MS) patients who have shown improvement after eight weeks of treatment.
Fampyra has shown efficacy in people with all four major types of multiple sclerosis – relapsing remitting, secondary progressive, progressive relapsing and primary progressive. Fampyra has been shown to increase walking speed by 25%, irrespective of the type of multiple sclerosis.
Biogen is currently working on obtaining Pharmaceutical Benefit Scheme (PBS) reimbursement approval for Fampyra. The product will be available from October 2011.
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 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 ex-US development and commercialization of products containing fampridine.
Biogen has previously faced setbacks in gaining approval for Fampyra in ex-US territories. In January 2011, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended against the approval of Fampyra. Biogen has filed a request asking for a re-examination of the decision. Biogen also received a “Notice of Deficiency” from Health Canada for its regulatory application for Fampyra.
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.
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