After impressing analysts with its healthy prospects for growth over the next few years at a meeting in Leverkusen, Bayer offered yet more good news, this time regarding its potential blockbuster cancer drug Nexavar
The German firm and partner Onyx have submitted a marketing application to the European Medicines Agency for Nexavar (sorafenib) in the treatment of hepatocellular carcinoma, a cancer of the liver. The application is based on the impressive data that Bayer presented at the recent annual meeting of the American Society of Clinical Oncology in Chicago from a Phase III trial which showed that Nexavar extended overall survival by 44% in patients with hepatocellular carcinoma versus placebo. The firms added that a filing to the US Food and Drug Administration for liver cancer is planned for later this summer.
Susan Kelley, vice president of oncology at Bayer Healthcare noted that Nexavar marks a significant advance for patients because “it is the first drug therapy ever to demonstrate a significant survival benefit in liver cancer and it provides this important clinical benefit with a manageable toxicity profile".
Nexavar is currently approved in more than 50 countries for the treatment of advanced kidney cancer and Bayer recorded revenues of 47 million euros from the drug in the first quarter. It is being studied alone and in combination with other therapies across many different cancer types, including melanoma, non-small cell lung and breast cancer.
Rivaroxaban sales forecast doubled to 2 billion euros
Back at the Leverkusen meeting, Kemal Malik, Bayer Schering Pharma’s head of global drug development, spoke about the promise being offered by rivaroxaban, a novel treatment for venous thromboembolism partnered with Johnson & Johnson. He said that the compound showed impressive results in the recently completed RECORD3 study, a 2,500-patient Phase III trial for prevention of VTE after knee replacement surgery, the key findings of which will be presented at the Congress of the
International Society on Thrombosis and Haemostasis in July.
Dr Malik added that "we aim to provide an efficient prophylaxis for thrombosis for patients in the future and plan to submit the full data for regulatory review before the end of this year in Europe". Rivaroxaban will be marketed under the trade name Xarelto and Bayer has doubled its peak annual sales estimate for the drug to 2 billion euros, if approved.
$198 million deal signed with Zymogenetics for thrombin
Bayer also noted that it has acquired the commercialization rights outside the USA for rThrombin (recombinant human thrombin) from ZymoGenetics. The two companies also plan to jointly market the product designed for bleeding control during surgery.
Under the terms of the deal, ZymoGenetics will receive $30 million from Bayer this year once the deal is signed, and $40 million after US regulators approve rThrombin (a Biologics License Application has already been accepted by the FDA). The German firm will pay ZymoGenetics up to $128 million based on development milestones outside the USA and a maximum royalty of 20% on non-US sales, it was announced.
Dr Malik concluded by noting that "we expect our pipeline to produce 11 Phase III projects by the end of 2009," and highlighted the monoclonal antibody alemtuzumab, a multiple sclerosis compound that “has demonstrated in Phase II the best treatment effect ever seen in a controlled trial”.