Bayer and Onyx Pharmaceutical’s Nexavar has received its first approval in Europe, after being given a green light by regulators in Switzerland for the treatment of patients with advanced kidney cancer.
Nexavar (sorafenib), the first new drug in more than a decade to treat adults with advanced renal cell carcinoma, was launched in the USA earlier this year, following the thumbs up from the Food and Drug Administration last December. Bayer expects the drug to be available in EU countries in the second half of this year, pending approval by the European Medicines Agency.
With a peak sales potential of over 1 billion euros, the agent is a key player in Bayer’s future growth, and “the approval of Nexavar in Switzerland marks an important step in the brand’s entry into Europe,” remarked Dr Gunnar Riemann, Head of Bayer HealthCare's Pharmaceuticals Division.
Not only has the agent been shown to double progression-free survival of patients from three to six months on average, but it also appears to be much less toxic than current treatments for this type of cancer, such as interleukin-2 or interferon-alpha, and has the additional benefit of being dosed orally rather than by injection.
All this adds up to a drug with real blockbuster potential, and Bayer and Onyx recently launched a further Phase III trial of the agent in lung cancer, in addition to the ongoing late-stage trial in skin and liver cancer, further adding to its potential.
Meanwhile, Bayer has raised 2 billion euros ($2.4bn) via a bond, converting into new shares in 2009, to help pay for its takeover of Schering AG.
Last week, Bayer said it planned to acquire Schering for about $19.7 billion, with the new company’s drugmaking activities to be concentrated in a Berlin-based division called Bayer Schering Pharmaceuticals. The offer was 12% higher than an earlier hostile takeover bid by Merck KGaA, and the latter has said it will not increase its offer for Schering.
The fundraising is part of the company‚s previously announced equity capital raising measures aimed at bringing in up to 4 billion euros.