Biogen Idec (NASDAQ: [[ticker:BIIB]]), one of the world’s biggest makers of multiple sclerosis drugs, has some catching up to do in bringing an oral MS treatment to market. Swiss drug giant Novartis said today it has won FDA approval of an MS pill, which some see as more convenient than the injected treatments for the disease that Weston, MA-based Biogen and others sell.
Novartis’s once-daily pill fingolimod (Gilenya) is the first oral drug for relapsing forms of multiple sclerosis to hit the U.S. market, according to the company. Biogen, which is in late-stage development of its own MS pill called BG-12, was quick to issue a statement this morning to acknowledge Novartis’s drug approval. Yet the Biogen statement noted that the “long-term safety profile of Gilenya has yet to be established.”
Biogen is expecting to have data from a Phase III trial of its own oral multiple sclerosis drug in the middle of next year. The company now sells the injected MS treatments interferon beta (Avonex) and natalizumab (Tysabri), and those drugs accounted for 70 percent of the firm’s $1.2 billion in revenue for the second quarter of 2010. While natalizumab (which is co-marketed by the Irish drug maker Elan) has been Biogen’s fastest-growing product, the drug carries the risk of serious brain infections called progressive multifocal leukoencephalopathy (PML).
Multiple sclerosis is a disease in which the sheaths around nerves in the brain and spinal cord are damaged, causing lesions to form. Muscle spasms and loss of control of body movement are common symptoms of the disease.
Another major competitor in the pursuit of an oral MS drug is EMD Serono, a division of Germany-based Merck with U.S. headquarters in Rockland, MA. In July, the FDA granted EMD priority review of its experimental MS pill, cladribine, and the firm expects the agency to decide whether to approve the drug for the U.S. market by the fourth quarter of this year. Merck (not to be confused with Whitehouse Station, NJ-based Merck) is also one of Biogen’s rivals in the market for interferon beta.
Novartis says it has shown in a clinical study that its oral MS drug prevents relapses of multiple sclerosis better than Biogen’s interferon beta, which is the firm’s biggest selling drug.
Biogen’s shares were down 5.55 percent on the day to $55 per share as of 11:38 am Eastern time.
