Sanofi Pasteur expands C. difficile study into USA; gets rights to MRSA agent; parent withdraws few batches of pediatric H1N1 vaccine

Sanofi Pasteur, the vaccines division of French drug major Sanofi-Aventis, is expanding its Phase II clinical study of a vaccine against Clostridium difficile infection (CDI) into the USA. The trial started in the UK earlier this year.

The incidence of CDI has increased significantly in recent years in both North America and Europe. CDI-related treatments in these two regions of the world are estimated to be costing more than $7 billion a year. The recent emergence and spread of a hyper-virulent strain of C.difficile further highlights the importance of tackling CDI, the company noted.

"While the target indication for the vaccine is prevention, this trial - in recently infected patients - aims to provide early proof-of-concept of a vaccine approach to preventing recurring infection," said Michel DeWilde, senior vice president, R&D, Sanofi Pasteur. "Recurring infection occurs in at least 20% of patients experiencing a first CDI episode and even higher frequency in those who have had multiple episodes," he explained.

Buys rights to Syntiron's vaccine

Sanofi Pasteur has also entered into an exclusive, world-wide licensing agreement with US biotechnology firm Syntiron to develop and commercialize its prophylactic vaccine against Staphylococcus, including Methicillin-Resistant Staphylococcus aureus. MRSA is responsible for several difficult-to-treat infections in humans, sometimes referred to as multidrug-resistant Staphylococcus aureus because these bacteria are resistant to a large group of antibiotics, including penicillins.

Under the terms of the deal, Sanofi Pasteur will support the joint, preclinical development of the product, working cooperatively with Syntiron, and be responsible for all future developments, regulatory approval, and commercialization of the vaccine. The accord includes an undisclosed initial licensing fee, milestone payments, and royalty payments on future sales of the product.