MADISON, N.J., Aug. 22 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE - News) announced today it was notified by the U.S. Food and Drug Administration (FDA) of the Agency’s decision to cancel its September 7, 2006 Psychopharmacologic Drugs Advisory Committee meeting. The meeting was originally scheduled to provide a forum for FDA advisors to discuss and review data included in Wyeth’s New Drug Application (NDA) for desvenlafaxine succinate extended release for the treatment of major depressive disorder. After further review of the data, the FDA decided it was no longer necessary to hold the advisory committee meeting before issuing its action letter, which is expected in October 2006. Wyeth is encouraged by this development and believes that its comprehensive clinical trials program for desvenlafaxine succinate supports the product’s approval. The Company submitted its NDA to the FDA for desvenlafaxine succinate, a dual serotonin-norepinephrine reuptake inhibitor, in December 2005.
Facts About Depression
Depression is the most common serious mental disorder worldwide.
* Depression affects approximately 121 million people worldwide and is the fourth leading cause of disability and premature death. * The World Health Organization projects that by the year 2020, depressive disorders will become the second-leading cause of disability worldwide. * Depression is one of the most prevalent mental health conditions in the United States, affecting approximately 14.8 million American adults each year. * Women suffer from depression twice as often as men.
More treatment options are needed.
* Researchers estimate that approximately 50 to 60 percent of patients suffering from depression respond to antidepressant therapy, leaving a large percentage of patients with unresolved depression. * Patients who experience one episode of depression have a 50 to 60 percent chance that it will recur.
Wyeth Is Committed to Neuroscience Research and Development As a leader in neuroscience, Wyeth’s discovery and development of desvenlafaxine succinate demonstrates its commitment to developing pharmaceutical products to help address the unmet needs of patients living with mental illness. In addition to the investigational compound desvenlafaxine succinate for major depressive disorder, the Company also has active research programs in other mental health areas, including bipolar disorder, schizophrenia, and Alzheimer’s disease.
About Wyeth
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 nonprescription 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 based on current expectations of future events and 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 risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third- party payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, 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.” We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Source: Wyeth
