Sanofi-Aventis expands deal with Regeneron to $160 million pa to end 2017

France's Sanofi-Aventis and USA-based Regeneron Pharmaceutical have entered into an agreement to expand and extend their existing global collaboration to discover, develop, and commercialize fully-human therapeutic monoclonal antibodies through 2017, which would cost the French drug major over $1 billion over the eight years to expand its foot-print in biotechnology.

Under the extended deal, Sanofi will increase its annual funding commitment from $100 million a year to $160 million beginning 2010 and has an option to extend the program for up to an additional three years. Both the companies confirmed that the current amendment did not alter their pre-existing financial terms of the November 2007 accord governing the development and commercialization of antibody drug candidates arising from the discovery collaboration.

The companies aim to advance an average of four to five antibodies into clinical development each year. In addition to its proprietary VelocImmune technology, Regeneron will contribute to the collaboration its next generation technologies related to antibody generation.

"The first two years of our collaboration with Sanofi-Aventis have been extremely productive, with five VelocImmune human antibodies in or entering clinical development," commented Leonard Schleifer, president and chief executive of Regeneron. "The expansion of our collaboration provides even greater resources over a longer time horizon and will boost our efforts to build a deep pipeline of new human antibody product candidates,' he added.

"This collaboration expansion demonstrates Sanofi-Aventis' commitment to become a key player in the field of monoclonal antibodies and our confidence in our partner Regeneron," declared Marc Cluzel, executive vice president, R&D, at Sanofi, noting that "it will further fuel our product pipeline and will allow us to bring multiple antibody product candidates into the clinic, thereby significantly increasing the chance of providing patients access to innovative drugs in various therapeutic areas."

To date, Regeneron and Sanofi have advanced four therapeutic antibodies into clinical development and have filed an Investigational New Drug for a fifth additional antibody. Among the four antibodies in clinical development, three are antibodies to (1) the Interleukin-6 receptor (IL-6R), being developed for the treatment of rheumatoid arthritis, (2) Nerve Growth Factor, being developed for the treatment of pain, and (3) Delta-like Ligand 4 (Dll4), being developed for the treatment of advanced malignancies. The targets of the two other antibodies have not been disclosed.

As under the original terms, Sanofi has the exclusive option to co-develop with Regeneron each antibody drug candidate discovered under the collaboration. Development costs for drug candidates co-developed will be shared, with the French firm funding development costs upfront and Regeneron reimbursing half of these for all collaboration drug candidates from US company's share of future profits from commercialization of collaboration products to the extent future profits are sufficient for this purpose. In the USA, profits will be shared equally, while outside America, profits will be split on a pre-determined sliding scale, with Sanofi's share ranging from 65% to 55%.