Replies to post #193086 on Biotech Values

[DewDiligence]

Roche/EXEL report positive OS data in phase-3 trial of Cobimetinib in BRAF-V600-positive melanoma:

http://finance.yahoo.com/news/exelixis-announces-positive-overall-survival-050000319.html

Exelixis, Inc. today announced positive overall survival (OS) results from coBRIM, the phase 3 pivotal trial evaluating cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma carrying a BRAF V600 mutation.

Exelixis’ collaborator Genentech, a member of the Roche Group, informed the company that coBRIM met its secondary endpoint of demonstrating a statistically significant and clinically meaningful increase in overall survival for patients receiving the combination of cobimetinib and vemurafenib, as compared to vemurafenib monotherapy. Ongoing study monitoring did not identify any new safety signals. Long-term safety data are expected later this year. These data will be the subject of a presentation at an upcoming medical meeting.

The PDUFA date for this combination regimen is 11/11/15.

In the EU, this regimen was endorsed by the CHMP in Sep 2015, so formal approval for marketing is imminent.

[DewDiligence]

EXEL/Roche—FDA approves Cotellic*/Zelboraf combination for metastatic melanoma with BRAF V600E or V600K mutation:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm471934.htm

The PDUFA date was tomorrow, which is a federal holiday.

*f/k/a cobimetinib.