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Pharmaceutical Technology Asia Pacific

R&D

Japanese approval for advanced treatments

Two companies have won approval for their products, which will give Japanese people access to two important treatments. Bayer (Germany) received approval for Nexava — its treatment for advanced renal cell carcinoma (RCC), while Sanofi-aventis (France) won approval for Clexane for the prevention of venous thromboembolism in patients undergoing orthpaedic surgery of the lower limbs, such as hip replacement, total knee replacement and hip fracture surgery.

Gunnar Riemann, member of the board of management of Bayer Schering Pharma AG, says: "This approval is a crucial step for patients with advanced kidney cancer in Japan, and also a major accomplishment for the company's oncology franchise in Japan." RCC is the most common form of kidney cancer. In Japan, there are currently 10000 patients suffering from the kidney cancer and 80%–85% are diagnosed with RCC. Nexavar will be the first oral targeted therapy to be approved in Japan.

Meanwhile, Hanspeter Spek, executive vice-president pharmaceuticals operations of Sanofi-aventis, believes that Clexane will "fulfil an important medical need for patients undergoing orthopaedic surgery." The recommended dose of the drug was established with the results of Japanese clinical trials and further clinical studies are also being conducted to extend Clexane's use to abdominal surgery patients who are at risk of venous thromboembolic complications.

http://www.bayer.com/
http://www.sanofi-aventis.com/

29 August 2008
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