Biogen's MS pipeline has been in the spotlight this week due to negative Phase II data for CDP323 and the company's announcement of an agreement to develop and commercialize Fampridine SR outside the US. While the CDP323 results have led to the drug being shelved, Biogen's continuing activity in broadening its strong MS pipeline shows its resolve in maintaining its leading position in this market.
Biogen has entered into a $510 million collaboration with Acorda Therapeutics for Fampridine SR, an MS pipeline drug which is currently under review by the FDA. An upfront fee of $110 million and additional payments totaling $400 million will give Biogen the rights to commercialize Fampridine SR worldwide (apart from the US). This agreement was announced after the shelving of its mid-stage drug, CDP323, an orally active alpha 4 integrin inhibitor, after it failed to demonstrate any clinical benefit compared to placebo in a Phase II trial.
MS is an autoimmune disease in which the central nervous system is attacked by the body's immune response resulting in the steady deterioration of neurological function, affecting approximately two million people worldwide. At present, Biogen has two leading drugs used in the treatment of MS: Avonex and Tysabri. Negative news of a 10th case linking Tysabri to progressive multifocal leukoencephalopathy (PML) was also announced recently. However, Datamonitor maintains its opinion that Tysabri's superior efficacy against relapsing MS outweighs the slight risk of developing PML, forecasting the drug to generate peak annual sales of over $1.3 billion in 2013.
Fampridine SR, a potassium channel blocker, represents a potential novel and important therapeutic option for people with MS who have a walking impairment. Difficulties with walking are among the most pervasive and debilitating problems faced by people with MS, and with no current therapies indicated to improve walking impairments in MS sufferers, clinicians are limited in their ability to address this aspect of the disease. The FDA has assigned Fampridine SR priority review and a Prescription Drug User Fee Act date of October 22, 2009. More recently, Acorda announced that the European Medicines Agency has confirmed that Fampridine SR is eligible to be submitted for a Marketing Authorization Application via the agency's centralized procedure.
Beyond CDP323, Biogen has four other late-stage disease-modifying MS projects in development: BIIB017, Panaclar (BG-12), ocrelizumab and Zenapax (daclizumab). Despite CDP323's failure, the addition of the potential symptomatic-relieving Fampridine SR complements Biogen's late-stage MS pipeline and will help maintain the company's leading position in the MS market.