Roche Holdings Ltd. (RHHBY) and Bristol-Myers Squibb Co. (BMY) recently announced a collaboration for the development of a combination drug involving Roche’s vemurafenib and Bristol-Myers’ ipilimumab to treat patients with BRAF-mutated metastatic melanoma (skin cancer).
According to the agreement, the companies will conduct a phase I/II study to determine the safety and efficacy of the combination drug. On the basis of the trial results, Roche and Bristol-Myers will decide on the further development of the drug.
Roche is currently evaluating vemurafenib as a treatment for patients with BRAF V600 mutation-positive metastatic melanoma. The company made regulatory filings in the US and European Union (EU) in May, seeking approval for the candidate for the aforementioned indication.
Roche, which is developing vemurafenib under a license and collaboration agreement with Daiichi Sankyo, presently has a mid-stage trial ongoing with vemurafenib for the treatment of thyroid cancer.
Bristol-Myers had launched ipilimumab (trade name: Yervoy) in the US in April, as a treatment for metastatic melanoma for both treatment-naïve and treatment-experienced patients. The drug was recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May. Ipilimumab is also filed for approval in countries like Australia and Canada. The regulatory authorities are expected to take a call during 2011.
Our Take
We currently have a Zacks #3 rank (short-term Hold rating) on both Roche and Bristol-Myers. We believe that this deal will benefit both these companies as the combination drug of vemurafenib and ipilimumab will help fight metastatic melanoma in a better manner.
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