Shortage of life-saving anti-rabies vaccine could become severe across as the he Bombay High Court has stopped Aventis Pharma Verorab, as part of an ongoing litigation between the company and Novartis.
The High Court stay on distribution of Verorabr will continue for eight weeks from the day the arbitration tribunal is constituted.
Aventis, which distributes Verorab in India also supplies Rabipur, another anti-rabies vaccine from a joint venture between the company and Novartis.
Novartis Vaccines & Diagnostics (USA), in a petition alleged that Aventi’s distribution of the rival product Rabipur contravenes the interests of the Chiron Behring Vaccines (CBVPL).
Novartis holds a 51% stake Chiron Behring Vaccines (CBVPL), while Aventis has the rest.
Rabipur manufactured at CBVPL’s Ankleshwar facility has been distributed by Aventis in India, Pakistan, Nepal, Bangladesh and Sri Lanka, following amarketing and distribution agreement with Aventis in 1998.
However, Aventis started distributing Verorab, which was manufactured by the Sanofi Aventis Group and imported in India by Sanofi Pasteur India, since September.
Novartis could secure an interim stay in October, but the interim injunction has been declared to continue further until the arbitration begins.
Rabipur sales contributed Rs117.94 crore to Aventis for the year ended 31 December. In the first quarter of 2009, Rabipur sales declined 75% to Rs9.2 crore from Rs 36.1 crore a year earlier to Aventis Pharma’s revenue growth.
India accounts for 50% of the mortality from rabies worldwide. Over three million people undergo anti-rabies treatment every year in India, where around 30,000 die annually of the disease.
Verorab is one of the leading rabies vaccine brands in India. Bharat Biotech International Ltd’s Indirab and Serum Institute of India’s Rabivax are othe other leading products in the segment.
SII Rabivax rabies vaccine U.S.P. (Adsorbed) s a single sterile, cell culture derived rabies vaccine for pre-and post-exposure prophylaxis in humans. It is prepared with Pitman-Moore strain of rabies virus. The virus is propagated on human diploid cells. The virus is inactivated with ß propiolactone. After inactivation the virus is adsorbed onto aluminum phosphate.
Sanofi Pasture’s Verorab is purified rabies vaccine cultured on Vero cells, Verorab is WHO-approved for pre- and post-exposure prophylaxis by intradermal and intramuscular routes.
During 20 years of use, over 40 million doses of Verorab have been administered in more than 100 countries.
Two thousand one hundred and eighty-three subjects received post-exposure prophylaxis, including 874 high risk, severe or confirmed rabid attacks. Co-administration of rabies immune globulin (RIG) does not affect neutralizing antibody levels when Essen or TRC-ID regimens are employed; levels are lower with the Zagreb regimen.