Celtic, Resolvyx enter option agreement for RX-10045 to treat dry eye syndrome

Celtic Therapeutics Holdings L.P. (Celtic Therapeutics), a successor firm to Celtic Pharma, and Resolvyx Pharmaceuticals, Inc. (Resolvyx) announced today that they have entered into an option agreement relating to Resolvyx's RX-10045, a late-stage program for the treatment of dry eye syndrome and other ophthalmic conditions. In connection with the RX-10045 option agreement, Celtic Therapeutics purchased a note convertible into Resolvyx equity.

Under the terms of the option agreement, Celtic Therapeutics has an exclusive option to acquire and license rights to Resolvyx's RX-10045, in all eye indications. RX-10045 is scheduled to enter a Phase III randomized, placebo-controlled, multi-center study in 2011. As part of the agreement, Celtic Therapeutics may also license rights to and develop another 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.

Dry eye, one of the most common problems treated by ophthalmologists, and a $1.7 billion global market today, is a chronic, multifactorial disease 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.

"Celtic Therapeutics is excited to invest in Resolvyx's groundbreaking technology, which has already demonstrated impressive efficacy and safety in patients with dry eye syndrome," commented Peter B. Corr, Co-Founder and Managing General Partner of Celtic Therapeutics. "The market for dry eye products has grown substantially over the past several years, despite the fact that most patients are not satisfied with current therapeutic options. With the potential for improved efficacy, a much faster onset of action, an improved tolerability profile, and a strong patent estate, we believe RX-10045, if approved, would represent an important step forward in the treatment of this widely prevalent condition."

"We are delighted to be allied with Celtic Therapeutics in maximizing the therapeutic potential of Resolvins to treat dry eye syndrome and other eye disease," said Jamie Nichols, Chief Operating Officer at Resolvyx. "Celtic Therapeutics brings both the capital and the world class development expertise to advance RX-10045 through Phase III development in dry eye and to maximize the potential of Resolvins to treat eye disease more broadly. This will allow Resolvyx to dedicate our resources to pursue the exceptional therapeutic potential of resolvins for non-ophthalmic diseases."

"Our investment in Resolvyx and RX-10045 demonstrates Celtic Therapeutics' focus on novel classes of biologic or small molecule therapeutics that hold the promise of significant medical advances compared to currently available treatment options," commented Stephen Evans-Freke, Co-Founder and Managing General Partner of Celtic Therapeutics. "This is the fourth such transaction we have announced to date; we have previously announced our investment in Kolltan Pharmaceuticals, which is developing second-generation monoclonal antibody drugs targeting tyrosine kinase receptors for the treatment of many cancer types, and alliances with Spirogen for the development of small molecule cytotoxic anti-cancer drugs designed to circumvent drug-resistance mechanisms, and with Bellus Health for the final Phase III development of Kiacta for the treatment of AA Amyloidosis."