Eli Lilly, Alcon co-promote nonproliferative diabetic retinopathy therapy

Eli Lilly and Co. and Alcon Laboratories have reached an agreement to co-promote ruboxistaurin mesylate (proposed brand name, Arxxant) in the United States and Puerto Rico. The agreement is contingent upon FDA approval. The government agency is currently reviewing the oral drug as a treatment for moderate-to-severe nonproliferative diabetic retinopathy.

Once approved, Alcon will have primary responsibility for promotion to eye-care specialists, while Lilly will have primary responsibility for promotion to endocrinologists and primary-care physicians. As part of the agreement, Alcon will make milestone and marketing payments to Lilly and Alcon will be compensated based on product sales.

"We believe combining the respective expertise of Lilly and Alcon will allow us to maximize the value of this potential new therapy for patients, physicians, and our shareholders," said Khoso Baluch, Lilly's vice president of the U.S. diabetes business unit. "With this collaboration, we gain a highly reputable and experienced partner in the eye market. Alcon will lead the promotional efforts to the eye care community, increasing awareness of the benefits that Arxxant could provide if approved as the first oral medication to reduce the risk of vision loss associated with diabetic retinopathy."

"We are pleased to enter into this strategic collaboration with Lilly, a global leader in diabetes therapies, to market this diabetic retinopathy therapy that, if approved by the FDA, could reduce the risk of vision loss in the millions of adults who suffer from this condition," added Kevin Buehler, Alcon's senior vice president of the United States and chief marketing officer. "This co-promotion agreement is an important part of our strategy to expand our promoted product portfolio with new pharmaceutical treatments for retinal diseases and to further enhance our leadership position in ophthalmology."

In other news, Alcon Laboratories has received approval from the Ministry of Health, Labor, and Welfare in Japan to market two of its products: olopatadine hydrochloride ophthalmic solution 0.1% (Patanol) and moxifloxacin hydrochloride ophthalmic solution 0.5% (Vegamox).

Olopatadine solution provides both mast cell stabilizing and antihistamine properties in a single molecule, providing patients with rapid, effective, and lasting relief from the signs and symptoms of allergic conjunctivitis.

Moxifloxacin is used for the treatment of bacterial infections of the eye including, among others, conjunctivitis and keratitis (including corneal ulcer), as well as for surgical prophylaxis. Moxifloxacin is a fourth-generation fluoroquinolone eye drop formulated at a 0.5% concentration, providing high-drug concentration throughout relevant ocular structures. Its near-neutral pH of 6.8 provides for ocular comfort. In clinical studies, moxifloxacin has demonstrated excellent efficacy and therapeutic penetration.

Vegamox solution is currently approved as Vigamox solution in more than 40 countries around the world.