SAFLUTAN launched in United Kingdom and Spain

Sep 3 2009

Merck Sharp & Dohme (MSD) has launched SAFLUTAN™ (tafluprost) in the United Kingdom and Spain, and additional launches in other countries are expected over the next several months, pending regulatory approvals, the Company said today. Tafluprost, the first preservative-free ophthalmic prostaglandin, is licensed in the launch markets for the reduction of elevated intraocular pressure (IOP) in appropriate patients with primary open-angle glaucoma and ocular hypertension.

Tafluprost is a synthetic analogue of the prostaglandin F_2α, and may offer benefits for patients with glaucoma, including those patients who experience certain adverse reactions associated with eye drops that contain preservatives, such as those who have dry/sensitive eyes or chronic eye diseases. Tafluprost may be used as monotherapy in patients who would benefit from preservative free eye drops, are insufficiently responsive to first line therapy, or are intolerant or contraindicated to first line therapy. It may be used as adjunctive therapy to beta-blockers. The recommended dose is one drop of tafluprost in the affected eye(s) once daily in the evening.

On April 15, 2009, Merck & Co., Inc. which operates in many countries as Merck Sharp & Dohme or MSD, and Santen Pharmaceutical Co., Ltd. announced a worldwide licensing agreement for tafluprost. Under the terms of the agreement, Merck agreed to pay an undisclosed fee as well as milestones and royalty payments based on future sales of tafluprost (both preserved and preservative-free formulations) in exchange for exclusive commercial rights to tafluprost in western Europe (excluding Germany), North America, South America and Africa. Santen will retain commercial rights to tafluprost in most countries in eastern Europe, northern Europe and in countries in the Asia Pacific area, including Japan. Merck will provide promotion support to Santen in Germany and Poland. If tafluprost is approved in the U.S., Santen will have the option to co-promote it there. SAFLUTAN marketed by MSD, and TAFLOTAN^®, marketed by Santen in respective territories, is the only preservative-free prostaglandin currently available for patients with glaucoma.

“MSD is pleased that we are now able to begin supplying SAFLUTAN in approved markets to continue the long standing commitment of Merck to ophthalmology and the patients who suffer from ophthalmic diseases worldwide." said Dr. Vlad Hogenhuis, Senior Vice President of Neuroscience and Ophthalmics, Merck & Co., Inc.