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CombinatoRx, Fovea collaborate on new ophthalmic therapeutics
Fovea will access CombinatoRx compounds under arrangements that differ by indication.
Candidates for inflammation and allergies in the front of the eye may be purchased for up to $20 million in upfront, milestone, and royalty payments, with Fovea retaining development and commercialization rights. For dry eye and diabetic macular edema, Fovea would fund preclinical and clinical trials up to pivotal trials, then share costs with CombinatoRx although no milestones or royalties would be paid, and commercial rights would be divided. Intellectual property and clinical trial data would be jointly owned.
Daniel Grau, senior vice president of commercial operations at CombinatoRx, says the collaboration fits the company's business strategy, which has "created a large portfolio of synergistic drug combinations through the screening that we've done over the last five years." Grau sees the Fovea deal as an innovative route for developing drugs for eye disease, "a category where you have to have some specialized knowledge." Fovea, he says, will bear the risks and costs of drug development while providing CombinatoRx with funding and "a very significant position in terms of product rights" under an open-ended agreement.
Bernard Gilly, Fovea CEO, co-founder and chairman, sees CombinatoRx's candidates as "quality drugs in the sense that they are going to bring something new to the patients. We've been reviewing a number of these drugs," he says, looking at the possibility of repurposing approved central nervous system drugs for use in the eye and retina, which Fovea sees as part of the brain.
Fovea intends to investigate drugs for allergic and inflammatory disorders in the front of the eye as well as for diabetic macular edema and dry eye. Dry eye treatments are lucrative, according to Visiongain, a market research firm that predicts the drug markets for the disease at $1.805 billion for 2009, up from only $580 million in 2002. Visiongain forecasts total worldwide ophthalmic pharmaceuticals markets of over $14 billion by 2009, up from $5.85 billion in 2002.
Developing combinations of approved drugs that reinforce each other's signals will still require clinical trials to assess side effects and efficacy in new indications, but established safety profiles help create "an avenue to reduce our time to the clinics," says Gilly, plus "a very, very important risk reduction factor that we can apply." One intriguing combination is the use of low doses of steroidal drugs together with compounds that amplify the steroid's signals, he says, "so when we dig into CombinatoRx's data, it was obvious that they're getting the same effect of a full dose of steroids with a limited dose." Steroidal eye drugs can cause side effects that include glaucoma and cataracts.
CombinatoRx has seven drugs in its own clinical program, says Grau, and actively pursues collaborations with disease foundations that try to quickly bring new therapies for unmet needs to patients. Grau says that CombinatoRx also has a significant collaboration with Angiotech Pharmaceuticals for using combination compounds with stents. CombinatoRx's platform joins combination high-throughput screening, which Grau calls "technology for screening large numbers of combinations of compounds and generating large amounts of combination data," with its Chalice, "the capability for rapidly analyzing all of the data that you just created and automatically selecting synergistic versus nonsynergistic combinations."