October 23, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Cambridge-based biopharmaceutical company Biogen Idec has seen its share price sag more than 5 percent after announcing yesterday that a patient died after taking its multiple sclerosis drug, Tecfidera.
Biogen stock plunged from $17.70 to $309.07, a loss of 5.4 percent, on the news.
Tecfidera, which is the company’s leading drug for the treatment of MS, is currently the best selling treatment for the condition. The patient developed a rare brain infection and his cause of death was officially ruled pneumonia. There was no definitive evidence linking Tecfidera to the death, but a Biogen Idec spokeswoman said that the company could not “rule out” the drug playing a role in the incident.
The brain infection is known in the medical community as progressive multifocal leukoencephalopathy, or PML. If this death is eventually linked to the Biogen Idec drug, it would be the first case associated with Tecfidera. Approximately 495 cases of PML were cited in patients taking Biogen Idec’s drug, Tysabri.
“We think the risk/benefit is clearly still in favor of using Tecfidera for nearly all patients,” RBC Capital Markets analyst Michael Yee told Reuters.
Biogen Idec recently reported a higher-than-expected quarterly profit and raised its full-year earnings forecast.
“For a company that’s been beating and crushing numbers, it’s hard to see people getting terribly excited about this,” Sanford Bernstein analyst Geoffrey Porges told Reuters. “You have to wonder if this is the new normal for Biogen or whether they can resume that spectacular growth.”
Tecfidera Shows Positive Results in Five-Year Study
On Sept. 11, Biogen Idec released news that a five-year study from the ENDORSE Phase 3 extension study showed that Tecfidera provided strong and sustained efficacy. Some of the patients in the study were treated for almost seven years and showed no new or worsening safety signals.
“Tecfidera continues to provide patients with effective oral treatment for MS that is supported by a growing body of data reinforcing its benefits and favorable safety profile,” said Alfred Sandrock, group senior vice president and chief medical officer at Biogen Idec. “These new ENDORSE results provide further insight into the positive impact of using Tecfidera early in the course of MS and for long-term treatment of this chronic disease.”
ENDORSE was a global, dose-blind extension study designed to test the long-term safety and efficacy of Tecfidera at 240mg, administered twice or three times a day.
