COLLEGEVILLE, Pa., & TARRYTOWN, N.Y. — Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that the companies have received marketing approval for RELISTOR[TM] (methylnaltrexone bromide) subcutaneous injection from the European Commission. RELISTOR is now approved in the 27 member states of the European Union as well as Iceland, Norway, and Liechtenstein for the treatment of opioid-induced constipation (OIC) in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient. RELISTOR is the first approved treatment for OIC in the European Union.
"The approval of RELISTOR by the European Commission is another major milestone for this innovative therapy, the first medicine approved for the treatment of opioid-induced constipation in advanced illness patients," says Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer of Progenics. "Approval in Europe significantly extends the availability of RELISTOR for advanced illness patients receiving palliative care who experience opioid-induced constipation, a potentially debilitating side effect of opioid therapy."
Joseph M. Mahady, President, Wyeth Pharmaceuticals, says: "We are proud to be able to offer this new innovation to physicians and health care providers caring for palliative care patients with advanced illness. We are pleased to have received regulatory approvals for RELISTOR from Canada, the United States, and Europe in quick succession, as they represent significantly developed markets for opioid use in palliative care patients."
Commercial launch of RELISTOR in Europe will be rolled out on a country-by-country basis, with the first launch anticipated to occur later this month.
RELISTOR, administered via subcutaneous injection, is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. Each year, more than 1.5 million Americans receive palliative care due to an advanced illness, such as incurable cancer and other end-stage diseases. Similar figures are not available for Europe as a whole.
About Subcutaneous RELISTOR
On April 24, 2008, the United States Food and Drug Administration approved RELISTOR subcutaneous injection for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The use of RELISTOR beyond four months has not been studied. RELISTOR was made available in the United States on June 2. On March 28, 2008, this form of RELISTOR was approved by Health Canada and was launched on May 27, 2008. A marketing application for subcutaneous RELISTOR was submitted to the Australian Therapeutic Goods Administration in August 2007 and is under review. Other applications in additional countries are also pending.
Important Safety Information for Subcutaneous RELISTOR
* RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
* If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician.
* Use of RELISTOR has not been studied in patients with peritoneal catheters.
* The most common adverse reactions reported with RELISTOR in clinical trials were abdominal pain, flatulence, and nausea.
* Full RELISTOR Prescribing Information for the U.S. is available at www.relistor.com.
About the Collaboration
In December 2005, Wyeth and Progenics Pharmaceuticals entered into an exclusive, worldwide agreement for the joint development and commercialization of methylnaltrexone.
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About the Companies
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. 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, nutritionals 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.
WYETH DISCLOSURE NOTICE: 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. In particular, there can be no assurance that RELISTOR will be commercially successful or that RELISTOR will be approved in the future in other formulations or indications and/or in other countries. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by forward-looking statements 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; 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.
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