Sanofi-Aventis and partner Bristol-Myers Squibb have sufferd a new setback in their bid to reduce the damage caused by the sale in Germany of a generic version of their blockbuster blood thinner Plavix.

Switzerland-based Acino, known before September 1 as Schweizerhall, says that a German high court, in North Rhine-Westphalia, has dismissed objections by Sanofi against the immediate enforcement of approval granted in the country earlier this year for generic Plavix/Iscover (clopidogrel). Acino, which developed the copycat verson, had been given the green light from the German Federal Institute for Drugs and Medical Devices (BfArM, the country’s regulatory authority) to launch clopidogrel in May.

Sanofi and B-MS have tried a couple of times and tried to get the court to get a temporary suspension against approval but those efforts have come to nought. Now Acino notes that the initial drug approval remains in effect and the two products containing generic clopidogrel (sold by Ratiopharm and Novartis unit Hexal), which were launched at the end of July, “continue to be marketed offering patients a cost-effective treatment alternative”.

Furthermore, the latest decision “cannot be challenged by ordinary appeal" and Acino added that "a main case is not pending". Sanofi is reportedly weighing up its legal options.

Plavix sales in Germany in the past year totalled more than 350 million euros but the arrival of competing products could smash Sanofi’s monopoly of the market. Hexal is selling its product at a price roughly 25% below that of the branded version.

Acino, which is headquartered in Basel, had revenues last year of over 180 million Swiss francs, a figure that is now sure to rise.

Sanofi/Daiichi Sankyo meningitis jab delayed in Japan
Sanofi’s day had already started badly after it was announced by the firm and partner Daiichi Sankyo that the launch in Japan of ActHIB, a paediatric vaccine for the prevention of meningitis caused by Haemophilus influenza type b, has been delayed.

The JV set up by the companies, Sanofi Pasteur-Daiichi Sankyo Vaccine, had previously said that ActHIB woulfd be launched this summer. However, it now says that it has taken more time than expected “to manufacture the batch meeting the in-house criteria established for the product toward the Japanese market”.

ActHIB, which is already available in more than 120 countries worldwide, was approved by Japanese regulators in 2007 and will be the first imported vaccine in the country. A launch is now expected at the end of the year.