Merck Sharp & Dohme Launches SAFLUTAN™ (tafluprost) in International Markets

The First Preservative-Free Prostaglandin Eye Drop for the Treatment of Elevated Intraocular Pressure in Primary Open-Angle Glaucoma and Ocular Hypertension

03/09/2009 — WHITEHOUSE STATION, N.J., U.S.A. — (BUSINESS WIRE)

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 F2?, 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.

Glaucoma consists of a group of diseases that can damage the eye’s optic nerve and can be associated with elevated intraocular pressure. Primary open-angle glaucoma is the most common form of glaucoma.

Selected Safety Information for Tafluprost

Tafluprost is contraindicated in patients with hypersensitivity to tafluprost or any of the excipients.

Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased pigmentation. Some of these changes may be permanent and may lead to differences in appearance between the eyes when only one eye is treated, including lifelong heterochromia. Caution is recommended when using tafluprost in aphakic patients, pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema or iritis/uveitis. Patients with severe asthma also should be treated with caution.

Ocular hyperaemia was the most frequently reported treatment-related adverse event in clinical studies of tafluprost (preserved and preservative free formulations), occuring in approximately 13% of the patients studied in Europe and the US. It was mild in most cases and led to discontinuation on an average in 0.4% of patients participating in the pivotal studies. Other common (?1%) adverse reactions were eye pruritus, eye irritation, eye pain, changes in eyelashes (increased length, thickness and number of lashes), dry eye, eyelash discoloration, foreign body sensation in eyes, erythema of eyelid, blurred vision, increased lacrimation, blepharal pigmentation, eye discharge, reduced visual acuity, photophobia, eyelid edema and increased iris pigmentation. Headache was also commonly reported.

About MSD

Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., which operates in many countries as Merck Sharp & Dohme (MSD), is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service.

Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck’s Form 10-K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Company’s periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.

SAFLUTAN is a trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.

CONTACT:

MerckPam Eisele, +1 908-423-5042

KEYWORDS:   United States  Europe  North America  New Jersey

INDUSTRY KEYWORDS:   Health  Clinical Trials  Optical  Pharmaceutical

MEDIA:

Logo