Biogen Idec is asking regulators in Europe to approve a prolonged-release version of fampridine as a treatment to improve walking in multiple sclerosis patients.

The company has announced the submission of a marketing authorisation application to the European Medicines Agency for fampridine PR tablets, and made a similar filing to Health Canada. The files are based on two Phase III trials, whereby “a significantly greater portion“ of fampridine-PR-treated patients had a consistent improvement in walking speed when compared to placebo (34.8% versus 8.3% and 42.9% vs 9.3% respectively). Subjects who had consistent improvement in the two studies experienced an average increase in walking speed of 25.2% and 24.7% compared to 4.7% and 7.7% for the entire placebo group.

Biogen has the licence for fampridine-PR outside the USA. The drug was developed by Acorda Therapeutics which received a recommendation for approval from a US Food and Drug Administration advisory panel in October. The agency is scheduled to give its final decision on fampridine-SR (as it is known in the USA) on January 22.

Biogen also announced that it has teamed up with Trillium Therapeutics, a Canadian biopharmaceutical company developing “innovative immune-based biologics” to get exclusive worldwide rights to one of latter's development programmes.

Under the terms of the agreement, financial details for which were not disclosed, Trillium will receive an upfront fee and milestone payments, plus royalties. Biogen will be responsible for clinical development, regulatory approvals, manufacturing and commercialisation.

Tysabri surpasses $1 billion mark
Meantime Biogen has given a business update to investors which reveals that sales of its MS drug Tysabri (natalizumab), partnered with Elan Corp, exceeded $1 billion in 2009. Speaking at the JP Morgan Healthcare Conference in San Francisco, chief executive James Mullen noted that the number of patients on the therapy climbed 30% compared with the prior year and as of December 31, 48,800 patients were receiving the drug commercially and clinically worldwide.

Mr Mullen said the company will continue to focus on accelerating the growth of Tysabri, while “actively pursuing lifecycle management initiatives” for its two other blockbusters, the older MS treatment Avonex (interferon beta-1a) and Rituxan (rituximab) for rheumatoid arthritis and non-Hodgkin's lymphoma. He added that Biogen will advance its “broad and deep pipeline of more than 20 programmes in Phase II and beyond” and “maintain disciplined use of cash through a combination of strategic investments and returning cash to shareholders”.