Sanofi-aventis has signed a binding agreement for the acquisition of Fovea Pharmaceuticals SA. (Fovea) a privately held French research and development biopharmaceutical company, focused on ocular diseases.

Created in 2005 in Paris, Fovea has a portfolio of three clinical compounds, a unique technology platform and several discovery programmes dedicated to back of the eye diseases.

Fovea's three products in clinical development are: FOV 1101, an eye drop, fixed dose combination of prednisolone and cyclosporine, currently in phase II for the treatment of persistent allergic conjunctivitis, FOV 2302, an intravitreal formulation of a plasma kallikrein inhibitor, in phase I for the treatment of Retinal Vein Occlusion induced macular edema and FOV 2304, a potent antagonist of bradykinin B1 receptors, active by eye drop, scheduled to enter in phase-I by November 2009 for the treatment of diabetic macular oedema.

"The acquisition of Fovea, one of the pioneer French biopharmaceutical ophthalmology company, is a further step in our company's goal to focus on new approaches to strengthen our R&D portfolio," declared Christopher A Viehbacher, chief executive officer of sanofi-aventis. "Fovea and its unique technology platform represent a major opportunity for sanofi-aventis in the very promising and dynamically growing ophthalmic area, driven by unmet medical needs and aging population. I am extremely excited to welcome Fovea in the sanofi-aventis family and to work with highly motivated teams to bring innovative solutions to patients for the treatment of ocular diseases."

In addition, Fovea has scientific capabilities designed around an innovative proprietary discovery platform, dedicated to ophthalmology and especially retinal diseases and several ongoing research and development programmes in glaucoma, retinitis pigmentosa and age-related macular degeneration.

Fovea is built upon close relationship with the Vision Institute, created and chaired by professor José A Sahel, at the National Eye Hospital in Paris, which gathers several research teams from University Pierre and Marie Curie, INSERM, CNRS, a Centre for Clinical Investigation fully dedicated to ophthalmology and the National Reference Center for Genetic Retinal Disease.

"We are extremely pleased to join sanofi-aventis as it will provide Fovea with the necessary resources and expertise needed to continue to aggressively grow our franchise and demonstrate the efficacy of our products through regulatory clinical development," said Bernard Gilly, president and chief executive officer of Fovea Pharmaceuticals. "With the continued support of our founder, professor José A Sahel, our team is highly motivated and we are confident that we will successfully contribute to bringing innovative treatments to patients at risk of loosing sight."

Under the terms of the agreement, sanofi-aventis has agreed to purchase Fovea for a total enterprise value of up to Euros 370 millions, including an immediate upfront payment and subsequent milestone payments related to the three clinical compounds.

The closing of the transaction is expected to occur in the forth quarter of 2009, subject to antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

FOV 1101 (prednisporin) is a fixed-dose combination low dose prednisolone acetate and low dose cyclosporin A for the topical treatment of persistent allergic form of conjunctivitis. In a first phase-II study, patients who will take benefit from the synergistic effect of prednisolone and cyclosporine have been identified. These encouraging preliminary results will have to be confirmed in a phase-IIb study which is planned to start in Q1 2010. Fovea has received exclusive worldwide rights to develop and commercialize FOV 1101 in ophthalmology.

FOV 2302 is the ophthalmic application of a recombinant plasma kallikrein-kinin inhibitor, in phase-I for the intravitreal treatment of macular oedema following retinal vein occlusion. Fovea has received exclusive rights to develop FOV 2302 in ophthalmology and to commercialize the product in Europe.

FOV 2304 is a bradykinin receptor antagonist, developed for the topical treatment of chronic macular oedema due to diabetic retinopathy. Scheduled to enter in phase-I before year end, this compound would represent a major therapeutic advance for diabetic patients who require a chronic, life-long treatment to avoid development of severe ocular complications, ultimately leading to vision loss. Fovea has received exclusive worldwide rights to develop and commercialize FOV 2304 in ocular indications.