Shares of Biogen Idec Inc. climbed in premarket trading Thursday, a day after federal regulators approved the drug developer's new multiple sclerosis treatment.
The Food and Drug Administration said Wednesday that it approved Tecfidera to control multiple sclerosis, or MS, in adults with hard-to-treat forms of the disease, a debilitating illness in which the body attacks its own nervous system.
There is no cure for multiple sclerosis. Most patients experience relapses of symptoms, including loss of balance, weakness in arms and legs, and blurred vision. Over time patients usually become weaker and less coordinated
The approval gives Biogen a new product in an increasingly crowded field of multiple sclerosis drugs. Biogen already sells two other drugs for the disease, but both require injections.
Other treatments on the market include Gilenya, the first pill-based multiple sclerosis drug, from Swiss drugmaker Novartis AG, and another pill, Aubagio, from French pharmaceutical giant Sanofi.
The top-selling drug for the disease worldwide is Copaxone, which is made by Teva Pharmaceutical Industries. That injection had sales of nearly $4 billion last year, according to Teva's latest financial report.
Tecfidera could reach $1.51 billion in global sales by 2015, according to Citi analyst Dr. Yaron Werber. He said in a research note that the projection looks conservative compared to a consensus expectation for $1.68 billion in sales.
Jefferies analyst Thomas Wei said in a separate note that the FDA approval came with a warning label that was better than he expected, requiring only annual monitoring of white blood cell counts. Wei said monitoring and testing requirements for Tecfidera are much less burdensome than those tied to Gilenya.
"We believe a requirement for annual blood draws will be viewed as benign and easily done within the context of regular follow-up visits with MS patients," the analyst wrote.
Wei raised his price target on shares of Biogen to $215 from $201.
The stock climbed more than 3 percent, or $5.59, to close at $182.68 on Wednesday. Shares rose another 1.3 percent, or $2.32, to $185 in trading about two hours before the opening bell on Thursday.
- Pharmaceuticals & Drug Trials
- Food and Drug Administration
- multiple sclerosis