Resolvyx Pharmaceuticals (Resolvyx) and Celtic Therapeutics Holdings (Celtic Therapeutics), a successor firm to Celtic Pharma, have entered into a final agreement under which Celtic Therapeutics has acquired and licensed worldwide rights related to Resolvyx’s RX-10045, a late-stage program for the treatment of dry eye syndrome and other ophthalmic conditions.
Terms of the deal include upfront consideration, near-term milestone payments, and funding for 100 per cent of future development costs. Resolvyx and Celtic Therapeutics will share proceeds from the future divestiture of RX-10045, including up-front payments, royalties or other revenues.
Under the terms of the agreement, Celtic Therapeutics will acquire and license rights to Resolvyx’s RX-10045, in all ophthalmic indications. RX-10045 is scheduled to enter a Phase III randomised, placebo-controlled, multi-centre study in 2011. As part of the agreement, Celtic Therapeutics may also license rights to and develop a second Resolvyx compound in a topical formulation for ophthalmic indications.
Resolvins are a recently discovered family of naturally-occurring, small molecule lipid mediators that can be targeted to treat a wide range of diseases. Resolvins are shown to be highly potent and efficacious across a broad range of pre-clinical models of asthma, atherosclerosis, rheumatoid arthritis, inflammatory bowel disease, dry eye and retinal disease, among others. Resolvyx will continue to develop Resolvins for non-ophthalmic indications.
Dry eye, one of the most common problems treated by ophthalmologists, and a USD1.7 billion global market today, is a chronic, multifactorial disease involving inflammation of the tear ducts and ocular surfaces that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surfaces. RX-10045, a resolvin administered as a topical eye drop, produced dose-dependent, significant improvement on the primary endpoints for both the signs and symptoms of dry eye, and was generally shown to be safe and well tolerated in a large placebo-controlled Phase II study.
“This innovative deal with Celtic Therapeutics will provide the necessary capital and clinical expertise to pursue our aggressive development plans for RX-10045 while allowing Resolvyx to share in the future success of this exciting program” said Greg Weinhoff, Executive Chairman at Resolvyx. “Resolvyx can now dedicate its internal resources to developing the exceptional therapeutic potential of resolvins for non-ophthalmic diseases.”
