Wyeth Provides Regulatory Update Regarding Desvenlafaxine for the Treatment of Major Depressive Disorder
Collegeville, Pennsylvania (ots/PRNewswire)
- Company Underscores Commitment to Availability in Worldwide Markets
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today provided an update on its global strategy for desvenlafaxine for the treatment of major depressive disorder (MDD) in adults.
Desvenlafaxine has already been approved for the treatment of MDD in adults in the United States, Australia and Brazil, and applications are currently pending in 22 markets. As part of its global regulatory strategy, and in consultation with the Committee for Medicinal Products for Human Use of the European Medicines Agency, the Company has chosen not to pursue its central European Marketing Authorisation Application at this time. Wyeth remains committed to making desvenlafaxine available to patients with MDD around the world, including in Europe. It is available in the United States under the name PRISTIQ.
"We are considering a number of options to support depressed patients and their families," says Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer. "There are millions of patients with depression, and clearly more treatments are necessary."
Wyeth has a long history of innovation in neuroscience. In 1993, the Company introduced the first serotonin-norepinephrine reuptake inhibitor, which has been prescribed to millions of people worldwide. Building on this research platform, desvenlafaxine represents Wyeth's newest antidepressant therapy.
About Wyeth Pharmaceuticals
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products (including future regulatory action regarding our pending applications in other countries for desvenlafaxine for the treatment of major depressive disorder and the treatment of vasomotor symptoms, as to which no assurance can be given); government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Contact:
Media: Gwen Fisher of Wyeth Pharmaceuticals, +1-484-865-5160, or
Douglas Petkus of Wyeth, +1-973-660-5218, or Investor Contact:
Justin Victoria of Wyeth, +1-973-660-5340