Alejandro Freixes
Oct 21, 2011

Biogen MS trial data robust; shares jump


By Toni Clarke
(Reuters) - Full data from a late-stage clinical trial of Biogen Idec Inc's experimental multiple sclerosis drug, BG-12, showed robust results across multiple measures and revealed no new safety concerns.
The news sent the biotech company's shares soaring as much as 6.7 percent on Friday.
Earlier this year the company released initial data from the trial, known as DEFINE, which showed the drug, when given twice a day, cut the annualized relapse rate by 53 percent at two years compared with placebo, and cut the rate of disability progression by 38 percent.
Full data from the trial was presented on Friday at a meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and showed the drug reduced the risk of relapse by 49 percent in patients who took it twice a day and 50 percent in patients who took it three times a day.
"BG-12 may be a valuable treatment option for MS patients, combining strong efficacy, a favorable safety profile and oral administration," said Dr. Ralf Gold, a trial investigator and professor at St. Josef-Hospital/Ruhr-University in Bochum, Germany. "Preclinical research has shown that BG-12 has anti-inflammatory and neuroprotective effects."
Multiple sclerosis is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, loss of vision and paralysis. BG-12 is designed to treat relapsing-remitting MS, in which flare-ups are followed by periods of remission. About 85 percent of people with MS are initially diagnosed with this form of the disease.
Gold said that if the clinical responses seen in DEFINE are replicated later this year in a second late-stage trial known as CONFIRM, then "BG-12 has the potential to provide a new approach to treating MS and be an important step forward for patients."
Magnetic resonance imaging (MRI) scans showed that at two years, patients receiving BG-12 experienced significant reduction in the number of brain lesions compared to patients on placebo.
"Coming out of Dr. Gold's presentation, BG12's clinical profile remains competitive with efficacy at the upper end of the range for all oral MS therapies," said Geoff Meacham, an analyst at J.P. Morgan, in a research note. "Importantly, there were no new safety concerns in the data presented, removing a major risk, and the immediate feedback from neurologists at the session was positive."
Adverse reactions were reported by 95 to 96 percent of patients, whether in the placebo group or treatment group. The most frequently reported events were flushing, MS relapse, nasopharyngitis, headache, diarrhea and fatigue. There were no deaths related to study treatment. There was no increase in infections, serious infections, opportunistic infections or malignancies, data showed.
Thomas Wei, an analyst at Jefferies & Company, said the data show that continued dosing of BG-12 beyond six months strengthens efficacy benefit, giving him increased confidence that the efficacy in DEFINE "will likely be replicated in CONFIRM."
The improvement in results with longer treatment likely explains why results from the two-year-long Phase III trial were significantly better than the six-month-long Phase II trial.
"BG-12 is clearly the trend of ECTRIMS 2011," said Geoff Porges, an analyst at Sanford Bernstein. "The sentiment is very positive and every physician that we spoke to repeated the same phrase: "If the CONFIRM data is as strong as DEFINE, this drug will be the best selling drug in MS in a few years."
Shares of Weston, Massachusetts-based Biogen were up 5.7 percent at $107.48 in mid-morning trading on Nasdaq after rising as high as $108.46 earlier in the session.
(Reporting by Toni Clarke, editing by Bernard Orr, Dave Zimmerman)