Emerging Drug Developer: Fovea Pharmaceuticals

Fovea eyes big markets for retinal diseases

Before Bernard Gilly, Ph.D., made a career switch and jumped into venture capital, he was the CEO of Transgene. But while he was a partner at Sofinnova, Gilly stayed in close contact with Professor José-Alain Sahel, a French scientist who specialized in studying retinal diseases. And that relationship would propel Gilly back to the head of a company – Fovea Pharmaceuticals – which was spawned in 2005 to commercialize Sahel’s work.

“At Sofinnova I was discussing and monitoring the progress of Jose-Alain’s research,” says Gilly from Paris. Both an academic and clinician, Sahel discovered a protein involved in the evolution of blindness. That discovery was followed by a series of discussions between the venture capitalist and the scientist about the development of new molecules that could target retinal diseases like age-related macular degeneration, retinitis pigmentosa, diabetic retinopathy or macular edema. As both an investor and an entrepreneur, Gilly was particularly impressed by the large patient populations affected by retinal degenerative diseases.

By June of 2005 Fovea was in business, and just months later Gilly helped arrange $25 million in Series A venture backing from a lineup of European sources: Sofinnova and Abingworth Management, The Wellcome Trust, GIMV in Belgium and Crédit Agricole Private Equity. In mid-December, all the investors would return for a $44 million round. So far, the company has in-licensed some short-term experimental products that are headed for the clinic as it advances Sahel’s preclinical discovery. And in late November a research pact with Genzyme provided a notable endorsement of Fovea’s technology platform as well as an encouraging sign that it can ink more such cash-spinning deals.

In the early part of this year, Fovea will make another big step forward. The biotech expects to advance its lead program -- FOV1101 for chronic allergic conjunctivitis -- into Phase II clinical trials. Phase II studies of its FOV2302 and FOV2301 programs for the treatment of acute and diabetic macular edema will follow later in 2008. The company expects to bring its fourth drug candidate, FOV2501, the protein discovered by Pr Jose-Alain Sahel's research team (Inserm-UPMC U 592), into clinical trials in the first half of 2009.

Fovea’s first mid-stage trial should get started in March, says Gilly.

“This compound is the only one we have for the surface of the eye disease, targeting allergic conjunctivitis.” That seasonal allergy can become perennial conjunctivitis, where there currently is no treatment, says Gilly. The experimental therapy, which was licensed in from CombinatoRx, is a proprietary formulation of a topical enhanced steroid.

“We can use a very low dose of steroid as if it’s high dose,” says Gilly.

The second program – 2302 -- for acute macular edema is an ophthalmic formulation of a small protein currently in a late-stage trial for a different indication. Gilly says that 2302 has already delivered positive results in a study using pigs, which have a retina very similar to humans. In animal studies, researchers have recorded a 50 percent reduction in the size of the edema.

Fovea’s third program is 2301, which also was licensed from CombinatoRx. That therapy closely follows 1101 -- targeting chronic diabetic macular edema with an enhanced steroid that could allow clinicians to avoid the side effects typically associated with steroids.

Fovea’s recent deal with Genzyme gives it the opportunity to identify new targets for retinal diseases in alliance with a high-profile discovery outfit. “This is a discovery platform which is specialized in the retina and only retinal diseases,” notes Gilly, who expects more such pacts to follow.

By the end of 2009, Gilly believes the company will be poised to begin a pivotal, late-stage trial for 1101. At that stage, Fovea can consider another financing round, an initial public offering or a sale. But Gilly clearly has a preference.

“I’d prefer to move to an IPO if the window is open,” he says. “We believe that in the retina space we have the capacity to grow the company as a specialty pharma company.”

There are only some 1500 to 1600 retinal specialists in the U.S. and another 1200 to 1300 in Europe, he notes. A limited sales force of 30 to 35 reps in the U.S. could successfully roll out a new product.

“If we can do this,” says Gilly, “we can go all the way through this. Or go the trade sale route.”