WASHINGTON (AP) -- Shares of Biogen Idec jumped to an all-time high Friday morning after the company said European regulators have determined its new multiple sclerosis is a novel drug, granting it 10 years of market exclusivity in the European Union.
THE SPARK: The Massachusetts drugmaker said in a statement that the European Medicines Agency granted its drug Tecfidera status as a "new active substance." The designation means that generic drugmakers will not be able to launch cheaper versions of the multiple sclerosis for 10 years, assuming it wins European approval.
The drug received a positive review by European experts in March, and a decision on approval is expected soon.
THE BACKGROUND: Analysts expect that Tecfidera, a pill taken once a day, will become a leading treatment for multiple sclerosis. The U.S. Food and Drug Administration approved it in late March. Biogen already markets three other drugs for multiple sclerosis in Europe, including the blockbuster Tysabri. In April Biogen paid $3.25 billion in cash to acquire full rights to Tysabri from partner Elan.
Multiple sclerosis is a disease in which the immune system attacks healthy nerves. It can cause pain, numbness, slurred speech, impaired vision, muscle weakness, and neurological problems.
SHARE ACTION: Shares of Weston, Mass.-based Biogen Idec Inc. rose $24.74, or 9.8 percent, to $277.17 in morning trading Friday after rising as high as $289.97, an all-time high, earlier in the day.
- Health Care Industry
- Biogen Idec
- multiple sclerosis
- European Medicines Agency