Scientists at Biogen Idec Inc. must be raising champagne glasses today after the company's announcement of year-end profits. Biogen posted a 26 percent increase over last year’s annual revenues, an extraordinary surge due in part to the swift growth of Tecfidera, the company’s oral multiple sclerosis (MS) drug, which achieved total sales of $876 million on its own. “2013 was a great year for Biogen Idec and the patients we serve,” said CEO George A. Scangos. Tecfidera, which has become the top-selling oral MS treatment in the U.S., has been prescribed by more than 6,000 doctors so far, according to Reuters.
Tecfidera, or dimethyl fumarate, reduces relapses and development of brain lesions in addition to slowing disability progression over time. Common side effects include mild to moderate flushing and diarrhea, nausea, and abdominal pain. The drug has been approved by the Food and Drug Administration for the treatment of relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis, often referred to as RRMS, the most common form of the disease.
MS is a chronic, often disabling disease that attacks the central nervous system, which is made up of the brain, spinal cord, and optic nerves. While some scientists believe MS to be an autoimmune disease, yet because the specific target of attack has never been identified, other scientists disagree and for this reason, MS is referred to as an immune-mediated disease. Symptoms range from numbness in the limbs to paralysis or even loss of vision. The progression, severity, and specific signs of MS vary from one person to the next. Though the disease is thought to be genetic, it is triggered in a susceptible individual by a combination of one or more environmental factors.
Doctors divide MS into four courses, with patients experiencing various degrees of severity for each: relapsing-remitting MS; primary-progressive MS; secondary-progressive MS; and progressive-relapsing MS. Approximately 85 percent of people are initially diagnosed with RRMS, in which patients experience clearly defined attacks of worsening brain function followed by partial or complete recovery periods (remission). Nearly 10 percent of people are diagnosed with primary-progressive MS, in which there is simply a steady worsening of neurologic symptoms minus remission. For many patients, after an initial diagnosis of RRMS, they enter a secondary-progressive course during which the disease increasingly worsens, with or without occasional flare-ups, minor remissions, or plateaus. Biogen, a biotechnology company founded in 1978, has focused its R&D efforts on therapies for patients with neurodegenerative diseases, hemophilia, and autoimmune disorders, including among its products two popular injectable MS drugs, Avonex and Tysabri.
Later in 2014, Biogen will begin to see early-to-mid stage clinical trial data for several potential drug formulations in the area of neurodegenerative and immunological diseases, including Alzheimer’s disease, idiopathic pulmonary fibrosis, MS, spinal muscular atrophy, and lupus. Scangos noted, “We are entering an exciting period as we plan for three new potential product launches this year, including two treatments for patients with hemophilia and the first pegylated interferon for MS — as well as the potential approval and launch of TECFIDERA in Europe.” The drug has already been approved and sold in Canada and Australia.