Biogen’s Longer-Lasting MS Drug Meets Goals in Late TrialMeg Tirrell
Biogen Idec Inc.’s longer-lasting injectable multiple sclerosis drug, peginterferon beta-1a, helped reduce the risk of relapse by 36 percent when given every two weeks, meeting the goals of a late-stage study.
The medicine trimmed patients’ danger of flare-ups by 28 percent when dosed every four weeks compared with placebo, the Weston, Massachusetts-based company said today in a statement. Based on the results, Biogen said it plans to apply this year for regulatory approval in Europe and the U.S.
Peginterferon is in the same class of drugs as Biogen’s best-seller, Avonex, which is given by injection once a week. Avonex generated $2.7 billion in 2011 revenue. The longer-lasting drug would be deemed successful if it cut the risk of relapse by at least 30 percent, Michael Yee, an analyst with RBC Capital Markets, wrote in a Jan. 16 note. Peginterferon may provide $600 million in annual sales by 2015, the average of three analysts’ estimates compiled by Bloomberg.
“Once per month should be approvable based on these data,” Mark Schoenebaum, an analyst with ISI Group, wrote in a note to clients today. “Many patients/physicians will still opt for the twice monthly given the probably better efficacy on many endpoints.”
Biogen rose 2 percent to $146.41 at the close of New York trading. The shares have gained 25 percent in the last 12 months.
The trial of more than 1,500 patients was part of the third and final stage of studies generally required for U.S. approval. The drug was safe and tolerable across different dosing frequencies, Biogen said. The most common side effects were redness at the injection site and flu-like symptoms.
Multiple sclerosis is a disease of the central nervous system that can lead to limb numbness, paralysis and vision loss. It affects about 2.1 million people worldwide, according to the National Multiple Sclerosis Society. The most common form is relapsing-remitting MS, characterized by sporadic flareups followed by periods of recovery.
In addition to Avonex, Biogen sells Tysabri, a once-monthly infusion with sales of $1.1 billion in 2011. Tysabri is associated with a higher risk of contracting a brain infection called progressive multifocal leukoencephalopathy, or PML, and is generally recommended for patients for whom other therapies haven’t worked as well. Biogen has developed a test to help determine patients’ risk.
The company is awaiting approval of its first pill for MS, BG-12. The Food and Drug Administration is scheduled to decide on the medicine by late March.
The trial reported today, dubbed Advance, showed peginterferon reduced the risk of disability progression by 38 percent at both doses.
“If approved, peginterferon beta-1a will represent an innovation that offers patients a less-frequent dosing schedule of no more than 26 doses annually, as well as a significant reduction in relapses and disability progression,” Gilmore O’Neill, Biogen’s vice president of global neurology late-stage clinical development, said in today’s statement.
The drug may help Biogen take market share from competitors and make it more difficult for generic copies of Avonex to enter the marketplace, Eric Schmidt, an analyst with Cowen & Co., wrote in a research note. “Hence the economic returns of PEG-Avonex to Biogen Idec could be significant,” he wrote.
Biogen Chief Executive Officer George Scangos addressed the benefits of less-frequent dosing in a presentation to investors earlier this month.
“These are injections,” Scangos said at JPMorgan Chase & Co.’s health-care conference in San Francisco. “And so being able to inject oneself once every two weeks, once every four weeks, and get efficacy that’s similar to what you would get injecting yourself every day seems like a no-brainer to me.”