OSI Pharma (OSI) and Roch Announce Tarceva Net Sales; ATLAS Data Sweep
Roche and OSI Pharmaceuticals (NASDAQ: OSIP) announced the net sales result for its oncology drug Tarceva. Sales for Q308 were approximately $301 million. Sales were $118 million in the U.S. and $183 abroad.
In addition, Roche has communicated to OSI that an exploratory ATLAS data sweep for survival was not positive. Survival was a secondary endpoint in the ATLAS study and the study was not powered to detect a significant difference in overall survival.
As OSI has previously communicated, OSI did not "opt-in" to the ATLAS study because the study was not designed to be registrational. If the study were to result in an ATLAS related 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. OSI is not currently forecasting any opt-in payments for this study.
In addition, Roche has communicated to OSI that an exploratory ATLAS data sweep for survival was not positive. Survival was a secondary endpoint in the ATLAS study and the study was not powered to detect a significant difference in overall survival.
As OSI has previously communicated, OSI did not "opt-in" to the ATLAS study because the study was not designed to be registrational. If the study were to result in an ATLAS related 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. OSI is not currently forecasting any opt-in payments for this study.
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