October 5, 2011 / 10:46 AM / 8 years ago

Biogen MS trial data reveals no safety surprises

* Details of DEFINE trial consistent with top-line data

* Safety profile encouraging, analysts say

* Results bode well for upcoming CONFIRM trial

By Toni Clarke

Oct 5 (Reuters) - Detailed data from a key trial of Biogen Idec Inc’s (BIIB.O) experimental multiple sclerosis drug BG-12 revealed no new safety concerns, and showed similar efficacy when given twice or three times a day, according to a summary of results to be presented at an upcoming conference.

Initial results from the trial, known as DEFINE, were released in April and 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.

Biogen said at the time that the side effects were similar to those seen in an earlier, mid-stage trial, but did not elaborate.

Multiple sclerosis is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision. 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.

A summary of detailed data to be presented at a meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) later this month, and posted on the group’s website late on Tuesday, did not show a meaningful difference in safety or efficacy than that seen in the initial data.

Moreover, the ECTRIMS summary showed a 48 percent reduction in annual relapse rate with three times a day dosing and a reduction in disability progression of 34 percent, in line with the results seen with twice a day dosing.

“These data confirm that the efficacy of the twice a day and three times a day arms were numerically very similar in DEFINE, and increase our confidence in the data,” said Thomas Wei, an analyst at Jefferies and Company, in a research note. “We are particularly encouraged that there is no material difference in discontinuations due to adverse events.”

About 16 percent of patients dropped out of the twice a day and three times a day group, compared to a rate of 13 percent for the group treated with a placebo.

Side effects included flushing of the face, which affected 38 percent of patients in the twice a day group and 32 percent in the three times a day group, compared to a rate of 5 percent in the placebo group. The incidence of serious adverse events was similar to the placebo, as was the incidence of infection.

“We view the safety profile as largely manageable,” said Geoff Meacham, an analyst at J.P. Morgan, in a research note. “As of right now, BG-12’s overall clinical profile does appear to be shaping up nicely.”

However, Meacham noted that investors’ expectations of BG-12 are relatively high, leaving Biogen little room for error.

Biogen is due to release data from a second late-stage trial of BG-12, known as CONFIRM, by the end of the year. If data from CONFIRM are positive, Biogen’s shares could rise as much as 10 percent, according to some analysts, and have the potential to fall as much as 20 percent if the data disappoints.

Biogen’s shares closed on Tuesday at $91.66 on Nasdaq.

Unlike most MS drugs, which are given by injection or infusion, BG-12 is taken orally. Oral drugs are expected to eventually become the most popular option for patients. So far the only oral drug to be approved in Gilenya, a drug made by Novartis AG NOVN.VX that is given once a day.

Gilenya has shown a reduction in annualized relapse rates of about 54 percent.

Some analysts expect BG-12, if approved, to generate more than $1 billion in annual sales. Weston, Massachusetts-based Biogen already makes the MS drugs Avonex and Tysabri. It shares sales of Tysabri with its partner Elan Corp Plc ELN.I. (Reporting by Toni Clarke)

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