Another oral drug coming soon - Data highlight safety profile of oral MS drug BG-12 - facebook prikbord

Data highlight safety profile of oral MS drug BG-12

Oral MS Drugs The latest data on Biogen Idec Inc.'s (BIIB) experimental multiple-sclerosis pill BG-12 show "favorable safety and tolerability" that support the drug's use as a front-line treatment for MS patients, the biotechnology company said.

Details from the "Confirm" study on BG-12 were set for presentation at an American Academy of Neurology conference Tuesday. The drug is currently under review with U.S. and European regulators and could be approved early next year.
Positive data and high expectations for the MS treatment have helped drive Biogen shares to around all-time high levels recently. Most treatments for the chronic, inflammatory and potentially disabling disease are delivered by needle, but BG-12 is an oral drug that will likely be taken twice daily.

The Biogen-funded Confirm study of about 1,400 MS patients showed the most common side effects for BG-12 patients at two years were flushing, or reddening of the skin, and gastrointestinal issues such as diarrhoea and nausea. These problems were more common with BG-12 than they were with a placebo, but the side effects "decreased substantially" for BG-12 patients after the first month of treatment, the company said.

Meantime, BG-12 had a lower rate than placebo when it came to serious adverse events, which were mainly relapses of MS attacks. Also, the incidence of serious infections "was low and balanced across the study groups," and there were no malignancies among BG-12 patients, Biogen said.

The overall incidence of adverse events for patients on placebo was 92%. The rate was 94% for patients on two daily BG-12 doses and 92% for patients on three daily doses. The rate of serious events was 22% for placebo, 17% for two daily BG-12 treatments and 16% for three daily treatments.

"The safety profile has continued to hold up nicely from one study to the next," said Doug Williams, Biogen's executive vice president of research and development, in an interview.

Williams also said that Biogen believes BG-12 "should be front-line therapy for patients" based on the risk-benefit profile seen in BG-12 studies.

Biogen first released results from the Confirm study in October. The study met its main treatment goal by showing a reduced annualised relapse rate--which takes into account the total number of relapses among all patients--for BG-12 patients compared with those on placebo. The study measured patients for two years and also included patients treated with Teva Pharmaceutical Industries Ltd.'s injectable MS drug Copaxone.

Biogen hasn't disclosed how much BG-12 is expected to cost, but has said the price will likely be comparable to other MS agents. Patients in the Confirm study had the relapse, remittingform of MS, which involves flare-ups rather than constant disease progression. This is the most common form of the disease.