Aventis granted two product approvals in Japan

The Japanese Ministry of Health, Labour and Welfare has granted approvals for two Aventis products: the insulin analogue Lantus (insulin glargine), and the antibiotic Ketek (telithromycin).

Lantus, which was launched in Germany in 2000, in the US in 2001, in the UK in 2002 and in France and many other countries in 2003, is a novel basal insulin administered once a day by injection for the treatment of both type 1 and type 2 diabetes. It demonstrates a slow, prolonged absorption and a relatively constant concentration/time profile for 24 hours, closely mimicking the natural physiological basal insulin secretion. Lantus generated sales of Euro 299m in 2002 and Euro 99m in the first half of 2003.

Ketek is the first of a new class of antibiotics known as the ketolides. Phase III clinical trials show that Ketek is highly effective against all relevant pathogens causing community-acquired respiratory tract infections (CARTIs). It was first launched in October 2001 in Germany and has been approved in all major EU and Latin American markets. Japan is the world's second largest market for antibiotics.

In February this year, Aventis entered into a marketing agreement with two of Japan's premier pharmaceutical companies, Sankyo Co. and Fujisawa Pharmaceutical Co. Aventis will manufacture Ketek for Sankyo and Fujisawa, who will market and distribute it in Japan. A Japanese launch is expected by the end of this year.

'The Japanese approval of Ketek is an important milestone for Aventis because it represents an important advance in treating community-acquired respiratory tract infections,' said Frank Douglas, executive vice president for global drug innovation & approval, and member of the management board at Aventis.