Sanofi-Aventis has been boosted by the green light granted for its prostate cancer drug Jevtana by European regulators.
Specifically, the French drugmaker has received marketing authorisation from the European Commission for Jevtana (cabazitaxel) in combination with prednisone/prednisolone for patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The company notes that it is the first approved agent to "significantly extend overall survival in mHRPC patients whose disease has progressed during or after treatment containing docetaxel", eg 15.1 months versus 12.7 months or patients on the chemotherapy mitoxantrone.
Debasish Roychowdhury, head of oncology at Sanofi, noted that Jevtana in combination with prednisone reduced the risk of death by nearly one-third and extended progression-free survival compared to mitoxantrone. As such, it offers "new hope for patients across Europe with limited treatment options should their disease progress following first-line therapy".
Jevtana has already been approved in Israel, Curacao and Brazil, as well as the USA where it received the green light in June 2010, more than three months ahead of schedule. The launch across the pond has exceeded Sanofi's expectations, and the drug brought in 82 million euros last year, after being on the market for less than six months.
Meantime, Sanofi and Merck & Co have abandoned plans laid out last March to combine their animal health businesses, Merial and Intervet/Schering-Plough respectively.
The companies issued a joint statement saying they are discontinuing their agreement "primarily because of the increasing complexity of implementing the proposed transaction, both in terms of the nature and extent of the anticipated divestitures and the length of time necessary for the worldwide regulatory review process".
Sanofi and Merck added that they will continue to operate their respective units independently. and "the termination of the agreement is without penalty to either party". Each firm is responsible for its own expenses.
A pact would have created a global leader in animal health with a market share of around 29%. The original deal would have seen Sanofi make a payment of $250 million to Merck toestablish the JV, plus $750 million under the terms of an agreementsigned in July last year when the Paris-headquartered company boughtMerck's stake in Merial for $4 billion. The latter agreed to that saleto speed up the approval process for its acquisition of Schering-Plough.