OSI Pharmaceuticals Inc and Genentech Inc have entered into two agreements detailing the roles of the two parties with respect to promotion, marketing and manufacturing responsibilities for the investigational drug Tarceva (erlotinib HCl) once it is approved for distribution in the United States, according to a company release.
As stated in the original agreement, Genentech will continue to be responsible for the marketing, launch and promotion of Tarceva. OSI will assist with the promotion of Tarceva by providing at least 25 per cent of the combined US sales force. The companies will continue to share responsibility for the ongoing development of Tarceva post-launch. OSI is responsible for obtaining the current approval by the FDA and is working to complete the NDA for Tarceva during the summer of 2004.
In January 2001, the companies signed an agreement for the co-development and commercialization of Tarceva in the United States. The agreements announced now include an amendment of the 2001 contract in order to further clarify the roles and responsibilities of OSI and Genentech around general principles outlined in 2001.
The second agreement signed now is a manufacturing agreement covering OSI's responsibilities in this regard. OSI is responsible for commercial manufacturing and supply of Tarceva in the US market.
"We have worked closely together with our colleagues at Genentech to detail the working relationship and responsibilities of each company in the post-launch environment," stated Colin Goddard, CEO of OSI Pharmaceuticals. "With the signing of these agreements we are even more confident that Tarceva will be positioned to compete effectively in the growing EGFR market in the US once it is approved," he added.
A phase III clinical trial of Tarceva in relapsed non-small cell lung cancer was successfully completed and a New Drug Application (NDA) rolling submission to the US Food and Drug Administration (FDA) is ongoing.