Biogen Idec (BIIB) recently announced the launch of Fampyra in Canada. Fampyra gained approval in Canada in February 2012 for the symptomatic improvement of walking ability in adult multiple sclerosis (MS) patients.
Biogen has a licensing deal with Acorda Therapeutics, Inc. (ACOR) for the development and commercialization of Fampyra in ex-US markets. Biogen is currently working on launching Fampyra in additional markets in the EU, where it gained conditional approval in July 2011.
Fampyra, which was launched in Australia, Denmark, Germany, Norway and the UK in 2011, posted sales of $13.6 million in 2011. Sales should increase in 2012 as Biogen launches the product in additional countries.
Fampyra is available in the US, under the trade name Ampyra, where it is being marketed by Acorda. Acorda received FDA approval in late January 2010, for the marketing of Ampyra in the US for improving walking speed in patients suffering from multiple sclerosis. Ampyra sales increased 58.2% to $210.5 million in 2011. Acorda expects Ampyra sales to increase to $255 – $275 million in 2012.
Neutral on Biogen
We currently have a Neutral recommendation on Biogen. The company is the market leader in therapies for the treatment of multiple sclerosis. We believe Biogen will continue to retain a leading position in the multiple sclerosis market. The company has been working on consolidating its position in the multiple sclerosis market and has an impressive late-stage pipeline of multiple sclerosis drugs including BG-12 (new drug application filed in the US in Feb 2012).
Besides BG-12, Biogen is developing other multiple sclerosis candidates like daclizumab, in partnership with Abbott Labs (ABT), and PEGylated interferon. Biogen recently signed an exclusive, worldwide option and collaboration agreement with privately held MAKScientific, LLC for the development and commercialization of drug candidates for the treatment of multiple sclerosis and other neurodegenerative diseases.
However, Biogen’s multiple sclerosis products face significant competition from products like Teva’s (TEVA) Copaxone, Pfizer/Serono’s (PFE) Rebif, Bayer’s (BAYRY) Betaseron and Novartis’ (NVS) Gilenya. Additional competition could come in the form of Sanofi’s (SNY) teriflunomide and Lemtrada.
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