BioWorld International Correspondent

PARIS - Fovea Pharmaceuticals SA signed an exclusive development and commercialization agreement with Novartis Pharma AG covering RdCVF (Rod-derived cone viability factor) for use in the treatment of retinal degeneration disorders.

Paris-based Fovea Pharmaceuticals, which is developing new drugs for treating back-of-the-eye (BOE) diseases such as retinitis pigmentosa, age-related macular degeneration, glaucoma, macular edema in venous occlusion and diabetic retinopathy, points out that RdCVF is a new protein factor that has shown promise for treating retinal degeneration.

The factor first was identified in a joint research program undertaken by Novartis, of Basel, Switzerland, and the French National Institute of Health and Medical Research (INSERM).

Under the license agreement with Novartis, Fovea will fund and conduct preclinical and clinical development of RdCVF up to the commercialization of an approved drug. In exchange for that development effort, Fovea has been granted exclusive worldwide commercial rights to RdCVF protein therapy. The agreement also gives Novartis the possibility of exercising a pre-negotiated one-time call-back option, which would include the payment of an up-front sum and royalties to Fovea.

On the other hand, should Fovea successfully bring RdCVF to market, Novartis would be eligible for development and regulatory milestones, as well as royalties on sales. Further financial details were not disclosed.

Bernard Gilly, president and CEO of Fovea, said, "This major in-licensing partnership with Novartis provides Fovea with a novel first-in-class drug that nicely complements our pipeline."

Fovea plans to develop RdCVF first in retinitis pigmentosa (RP), which is recognized as one of the most common inherited causes of blindness in people younger than 50. The company points out that since there is no known cure for RP, it qualifies as an orphan disease. The development of RdCVF subsequently could be extended to other pathologies, including the highly prevalent atrophic form of age-related macular degeneration (AMD).

Retinal degeneration encompasses a genetically heterogeneous group of retinal diseases with which more than 100 causal genes have been associated to date. RdCVF-based therapies potentially are applicable to various pathological conditions in which rod photoreceptors are affected initially and cones are involved secondarily, independent of the specific nature of the causative genetic mutation.

RdCVF acts by preventing cone cell death and by protecting remaining cones in patients suffering rod damage. Loss of cones causes disabling visual loss, as cone photoreceptor cells are responsible for central vision and central acuity, as well as color vision. In RP, as in other retinal degeneration disorders, treatment with RdCVF not only prevents cone cell death, but also helps preserve useful vision, even in patients with 95 percent cone photoreceptor loss.