BioWorld International Correspondent
PARIS - CombinatoRx Inc. and Fovea Pharmaceuticals SA signed a collaboration to develop new therapeutics in ophthalmology by exploiting synergistic drug combinations.
CombinatoRx, of Boston, is specialized in discovering novel combinations of drug candidates, while Paris-based Fovea focuses on drugs for treating back-of-the-eye (BOE) diseases, such as retinitis pigmentosa, age-related macular degeneration (AMD), glaucoma, macular edema in venous occlusion and diabetic retinopathy.
The first part of the agreement requires Fovea to fund and conduct the preclinical and clinical development of combinations of drug candidates selected from the CombinatoRx portfolio, including the creation of ophthalmic formulations.
It will develop promising combinations up to the start of Phase III trials. CombinatoRx will be joint owner with Fovea of the new intellectual property and data generated up to Phase III trials, and CombinatoRx will retain the rights to develop and commercialize the ophthalmic products in North America and certain other countries.
CombinatoRx will grant Fovea exclusive commercial rights to selected products in Europe and certain other countries, while they will have coexclusive rights in Japan and Taiwan.
CombinatoRx and Fovea would share the costs of Phase III trials and the regulatory filings, and each would commercialize in its respective territory.
Secondly, CombinatoRx is granting Fovea an exclusive worldwide license to certain preclinical drug combinations for the development of treatments for allergy and inflammatory diseases of the front of the eye.
For those licensed compounds, CombinatoRx could receive up to $20 million in up-front payments, development milestones and regulatory payments for the first product candidate developed, and an additional milestone payment for the approval of a product in an additional indication. CombinatoRx also would receive royalties on sales of every licensed product commercialized by Fovea.
The CEO and chairman of Fovea, Bernard Gilly, told BioWorld International that the bulk of the financial commitment would fall after Phase II, pointing out that Fovea was paying $250,000 up front and that $500,000 would be payable at the Phase I stage. He said Fovea would select one compound for clinical development in the first instance, and a Phase I trial would start in the first quarter of 2007 at the latest, and possibly as early as the fourth quarter.
The deal reflects Fovea's policy of in-licensing compounds from other biopharmaceutical companies that already are being developed for other pathologies, in addition to which the company aims to identify, validate and develop new chemical entities for BOE diseases.
Fovea has a technology that uses primary retinal cells to identify target proteins that play a central role in the development of retinal disorders. It said the technology has been validated with the identification of a new protein, the rod-derived cone viability factor.
Fovea Pharmaceuticals was founded in May and closed an initial funding round in November, raising €20.5 million from five European venture capital funds: Sofinnova Partners, of Paris; Abingworth Management, of London; The Wellcome Trust, also of London; GIMV, of Antwerp, Belgium; and Crédit Agricole Private Equity, of Paris.