Biotech Values

[genisi]

Tarceva did not meet its secondary endpoint of OS in the ATLAS study (Avastin+/-Tarceva in maintenance setting in NSCL).

OSI Pharma posts higher Tarceva global sales in Q3

http://www.reuters.com/article/rbssHealthcareNews/idUSBNG43914120091015?sp=true

Says global sales rise 8 pct

* U.S. sales rise 7 pct

Oct 15 (Reuters) - OSI Pharmaceuticals Inc (OSIP.O) reported higher third-quarter global net sales for its cancer drug Tarceva, which it co-markets with Roche Holding AG (ROG.VX).

For the quarter ended Sept. 30, Tarceva's global net sales were about $301 million, of which U.S. accounted for about $118 million, the company said in a U.S. regulatory filing.

In the corresponding quarter last year, Tarceva's global net sales were $279 million, with U.S. contributing $110 million.

The company also said Roche informed that an exploratory data sweep for survival from the Atlas study on Tarceva was not positive.

In the trial, called Atlas, patients with advanced non-small cell lung cancer were treated with Tarceva in combination with Genentech Inc's Avastin. [ID:nN02472881]

Survival was a secondary endpoint in the Atlas study and the study was not powered to detect a significant difference in overall survival, OSI said.

OSI said it did not "opt-in" to the study because it was not designed to be registrational.

If the study was to result in a change to the Tarceva label, OSI would likely be required to opt-in and pay its retrospective share of the study costs and a penalty, it said.

OSI said it is not currently forecasting any opt-in payments for the study.