FDA accepts Merck's SAFLUTAN NDA for standard review

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the New Drug Application (NDA) for SAFLUTAN^® (tafluprost), Merck's investigational preservative-free prostaglandin analogue ophthalmic solution, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). SAFLUTAN is the proposed trade name for tafluprost in the United States.

Merck submitted an NDA to support the proposed use of SAFLUTAN for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. SAFLUTAN is believed to help increase the fluid drainage that occurs through the root of the iris in the eye (this fluid is also known as aqueous humor). SAFLUTAN is currently approved in several European countries, including the United Kingdom, Spain and Italy. Additional launches in other countries are expected, pending regulatory approvals.

"Merck has been providing new therapies to help treat eye diseases for more than 50 years," said Joseph Markoff, Ph.D., M.D., global director, Scientific Affairs, Ophthalmology, Merck. "The acceptance of the NDA submission for tafluprost is an important milestone in our effort to bring forward an additional therapeutic option for patients with primary open-angle glaucoma or ocular hypertension."

On April 15, 2009, Merck and Santen Pharmaceutical Co., Ltd. entered into a worldwide licensing agreement for tafluprost. Merck has exclusive commercial rights to tafluprost in Western Europe (excluding Germany), North America, South America, Africa, the Middle East, India and Australia. Santen retains commercial rights to tafluprost in most countries in Eastern Europe, northern Europe and in countries in the Asia Pacific region, including Japan. Santen will have the option to co-promote SAFLUTAN in the United States, if approved.