Genentech will provide three-quarters of the sales force needed to promote the oncologic Tarceva in the U.S., with OSI assuming the remaining share under a commercialization agreement announced June 16.

"Genentech will continue to be responsible for the marketing, launch and promotion of Tarceva," the companies said. "OSI will assist in the promotion of Tarceva by providing at least 25% of the combined U.S. sales force."

OSI currently operates a 30-representative sales force in the U.S. and expects to build that team ahead of the Tarceva launch.

The agreement clarifies Genentech and OSI's development and marketing responsibilities for Tarceva (erlotinib), but does not significantly alter the original contract signed in January 2001.

"The agreements announced today 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 companies said.

OSI expects to complete the rolling Tarceva NDA submission this summer in time for a first quarter 2005 launch. The initial indication is expected to be for the treatment of relapsed non-small cell lung cancer. Genentech and OSI will continue to share development responsibilities post-launch.

A second agreement announced June 16 clarifies OSI and Genentech's manufacturing responsibilities. As in the 2001 contract, OSI will oversee commercial manufacturing of Tarceva for the U.S. market.

OSI has been using third-party contractors to manufacture Tarceva's clinical supply and will continue to outsource production after FDA approval. Roche is responsible for marketing and manufacturing Tarceva outside the U.S.

Genentech has been focusing its manufacturing activities on the colorectal cancer therapy Avastin by outsourcing manufacturing for a number of its existing products to free up capacity.

For example, Novartis is assuming global production of Xolair , and Roche is manufacturing Herceptin for European markets. Genentech has also transferred bulk production of Rituxan to Lonza.

- Kate Rawson

Tarceva Sales Effort Will Be Led By Genentech; OSI To Provide 25% Of Reps

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