Chugai, Roche deal

Roche granted its Chugai subsidiary exclusive rights to develop and commercialize vemurafenib in Japan. Roche is eligible for undisclosed milestones. Chugai plans to begin a Phase I trial to treat BRAF mutation-positive metastatic melanoma in Japan next year. Last week, FDA approved the product as Zelboraf to treat unresectable or metastatic melanoma in patients with BRAF V600E mutations as determined by an FDA-approved test. The agency simultaneously approved its companion BRAF V600 Mutation Test. The PCR-based nucleic acid test, which runs on Roche's cobas system, identifies patients whose tumors carry the mutation. Zelboraf, an oral small molecule inhibitor of the oncogenic BRAF V600E, is also under review in the EU. ...