ZioptanTreatment for Glaucoma (Open Angle), Intraocular Hypertension
Update: Zioptan (tafluprost) Now FDA Approved - February 10, 2012
FDA Accepts Saflutan NDA
Merck Announces FDA Acceptance of New Drug Application for Investigational Ophthalmic Medication Saflutan (tafluprost)
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Mar 9, 2011 - Merck, 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.
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This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
Saflutan® is a registered trademark of Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Pamela Eisele, 908-423-5042
Kim Hamilton, 908-423-6831
Joe Romanelli, 908-423-5088
Carol Ferguson, 908-423-4465
Posted: March 2011
- FDA Approves Zioptan (tafluprost ophthalmic solution), Merck's Once-Daily, Preservative-Free Ophthalmic Medication - February 13, 2012