Monday, May 12

"Biogen sees 'unlikely' link between Tecfidera and patients demise"

A report from BioPharm Insight noted that a patient who had taken Biogen's new multiple sclerosis drug Tecfidera had died, prompting a quick drop of about 3% in the biotech group's stock price, which recovered to about even later in the day.

A Biogen spokeswoman told Reuters that the death of the 59-year-old woman occurred two weeks after she stopped taking Tecfidera because of gastrointestinal problems. The MS patient had suffered from a form of pneumonia prior to her death. The news service reported that the death was unrelated to the GI problems, and the company said that it is "unlikely" that Tecfidera caused the fatal case.

The drama underscores the high visibility of Tecfidera, for which analysts have projected eventual peak sales of more than $3 billion. As long as the safety profile of the therapy remains within an acceptable range, Tecfidera could become the best-selling drug in the growing class of oral MS drugs, which includes such meds as Aubagio from Sanofi ($SNY) and Novartis' ($NVS) Gilenya.

ISI analyst Mark Schoenebaum wrote to investors that he viewed the death as a "non-issue" for the company's performance. The company told the top analyst that it is "still gathering info" on the case.

Tecfidera is perhaps the most anticipated drug from the Weston, MA-based biotech heavyweight since the launch of the MS therapy Tysabri, which the FDA initially approved in November 2004.

Tysabri was reintroduced in 2006 and has gone on to become a blockbuster drug, with tests now available to assess the risk of PML prior to treatment. Yet the issue showed how it can take a long time to dig out from a safety problem with a new drug. READ MORE