Replies to post #145205 on Biotech Values

[DewDiligence]

Actually, SNY never disclosed the submission date of Aubagio's US NDA, so we don't know for sure that the PDUFA date was in June.

Rather, SNY announced on 10/20/11 that the Aubagio NDA was accepted for review (#msg-68164569) It's barely possible that the NDA submission was made as late as mid Sep 2011, in which case the PDUFA date would be in mid July.

[DewDiligence]

Interferon drugs flop in Canadian long-term MS study:

http://www.bloomberg.com/news/2012-07-17/biogen-bayer-drugs-don-t-slow-ms-progress-study-finds.html

The study used data from the British Columbia Multiple Sclerosis database from 1985 to 2008. It compared three groups: 868 patients with relapsing-remitting MS who were treated with interferon beta therapy from July 1995 to December 2004; 829 patients who met the criteria to receive interferon beta therapy in that time period yet were untreated with it; and 959 patients who met the same criteria before interferon beta therapies became available in 1995 in Canada. The use of two control groups sought to eliminate the chance of bias based on patients choosing not to receive therapy for reasons such as less severe disease, the researchers wrote.

The study found that 10.8 percent of patients in the treated group reached an EDSS score of 6, compared with 5.3 percent in the contemporary untreated group and 23.1 percent in the historical untreated group.

“We did not find evidence that administration of interferon beta was associated with a reduction in disability progression in patients with relapsing-remitting MS,” the researchers wrote. “Our findings bring into question the routine use of interferon beta drugs to achieve this goal in MS.”