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Wyeth and Progenics Receive Approval from European Commission for RELISTOR for Opioid-Induced Constipation in Advanced Illness Patients

http://www.nbsme.gov.cn  宁波中小在线  时间:2008-7-4

    Pharmaceutical Writers/Business Editors/Biotech Writers

    COLLEGEVILLE, Pa., & TARRYTOWN, N.Y.--(BUSINESS WIRE)--July 3,2008--Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), andProgenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced thatthe companies have received marketing approval for RELISTOR(TM)(methylnaltrexone bromide) subcutaneous injection from the EuropeanCommission. RELISTOR is now approved in the 27 member states of theEuropean Union as well as Iceland, Norway, and Liechtenstein for thetreatment of opioid-induced constipation (OIC) in advanced illnesspatients who are receiving palliative care when response to usuallaxative therapy has not been sufficient. RELISTOR is the firstapproved treatment for OIC in the European Union.

    "The approval of RELISTOR by the European Commission is anothermajor milestone for this innovative therapy, the first medicineapproved for the treatment of opioid-induced constipation in advancedillness patients," says Paul J. Maddon, M.D., Ph.D., Founder, ChiefExecutive Officer and Chief Science Officer of Progenics. "Approval inEurope significantly extends the availability of RELISTOR for advancedillness patients receiving palliative care who experienceopioid-induced constipation, a potentially debilitating side effect ofopioid therapy."

    Joseph M. Mahady, President, Wyeth Pharmaceuticals, says: "We areproud to be able to offer this new innovation to physicians and healthcare providers caring for palliative care patients with advancedillness. We are pleased to have received regulatory approvals forRELISTOR from Canada, the United States, and Europe in quicksuccession, as they represent significantly developed markets foropioid use in palliative care patients."

    Commercial launch of RELISTOR in Europe will be rolled out on acountry-by-country basis, with the first launch anticipated to occurlater this month.

    RELISTOR, administered via subcutaneous injection, is aperipherally acting mu-opioid receptor antagonist that decreases theconstipating effects of opioid pain medications in thegastrointestinal tract without affecting their ability to relievepain. Each year, more than 1.5 million Americans receive palliativecare due to an advanced illness, such as incurable cancer and otherend-stage diseases. Similar figures are not available for Europe as awhole.

    About Subcutaneous RELISTOR

    On April 24, 2008, the United States Food and Drug Administrationapproved RELISTOR subcutaneous injection for the treatment of OIC inpatients with advanced illness who are receiving palliative care, whenresponse to laxative therapy has not been sufficient. The use ofRELISTOR beyond four months has not been studied. RELISTOR was madeavailable in the United States on June 2. On March 28, 2008, this formof RELISTOR was approved by Health Canada and was launched on May 27,2008. A marketing application for subcutaneous RELISTOR was submittedto the Australian Therapeutic Goods Administration in August 2007 andis under review. Other applications in additional countries are alsopending.

    Important Safety Information for Subcutaneous RELISTOR

    --  RELISTOR is contraindicated in patients with known orsuspected mechanical gastrointestinal obstruction.

    --  If severe or persistent diarrhea occurs during treatment,advise patients to discontinue therapy with RELISTOR andconsult their physician.

    --  Use of RELISTOR has not been studied in patients withperitoneal catheters.

    --  The most common adverse reactions reported with RELISTOR inclinical trials were abdominal pain, flatulence, and nausea.

    --  Full RELISTOR Prescribing Information for the U.S. isavailable at www.relistor.com.

    About the Collaboration

    In December 2005, Wyeth and Progenics Pharmaceuticals entered intoan exclusive, worldwide agreement for the joint development and
commercialization of methylnaltrexone.

    (PGNX-G)

    About the Companies

    Wyeth Pharmaceuticals, a division of Wyeth, has leading productsin the areas of women's health care, infectious disease,gastrointestinal health, central nervous system, inflammation,transplantation, hemophilia, oncology, vaccines and nutritionalproducts. Wyeth is one of the world's largest research-drivenpharmaceutical and health care products companies. It is a leader inthe discovery, development, manufacturing and marketing ofpharmaceuticals, vaccines, biotechnology products, nutritionals andnon-prescription medicines that improve the quality of life for peopleworldwide. The Company's major divisions include WyethPharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge AnimalHealth.

    WYETH DISCLOSURE NOTICE: The statements in this press release thatare not historical facts are forward-looking statements that aresubject to risks and uncertainties that could cause actual results todiffer materially from those expressed or implied by such statements.In particular, there can be no assurance that RELISTOR will becommercially successful or that RELISTOR will be approved in thefuture in other formulations or indications and/or in other countries.Other risks and uncertainties that could cause actual results todiffer materially from those expressed or implied by forward-lookingstatements include, without limitation, the inherent uncertainty ofthe timing and success of, and expense associated with, research,development, regulatory approval and commercialization of our productsand pipeline products; government cost-containment initiatives;restrictions on third-party payments for our products; substantialcompetition in our industry, including from branded and genericproducts; emerging data on our products and pipeline products; theimportance of strong performance from our principal products and ouranticipated new product introductions; the highly regulated nature ofour business; product liability, intellectual property and otherlitigation risks and environmental liabilities; uncertainty regardingour intellectual property rights and those of others; difficultiesassociated with, and regulatory compliance with respect to,manufacturing of our products; risks associated with our strategicrelationships; economic conditions including interest and currencyexchange rate fluctuations; changes in generally accepted accountingprinciples; trade buying patterns; the impact of legislation andregulatory compliance; risks and uncertainties associated with global
operations and sales; and other risks and uncertainties, includingthose detailed from time to time in our periodic reports filed withthe Securities and Exchange Commission, including our current reportson Form 8-K, quarterly reports on Form 10-Q and annual report on Form10-K, particularly the discussion under the caption "Item 1A, RISKFACTORS" in our Annual Report on Form 10-K for the year ended December31, 2007, which was filed with the Securities and Exchange Commissionon February 29, 2008. The forward-looking statements in this pressrelease are qualified by these risk factors. We assume no obligationto publicly update any forward-looking statements, whether as a resultof new information, future developments or otherwise.

    Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is abiopharmaceutical company focusing on the development andcommercialization of innovative therapeutic products to treat theunmet medical needs of patients with debilitating conditions andlife-threatening diseases. Principal programs are directed towardgastroenterology, virology - including human immunodeficiency virus(HIV) and hepatitis C virus (HCV) infections - and oncology.
Progenics, in collaboration with Wyeth, is developing RELISTOR(methylnaltrexone bromide) for the treatment of opioid-induced sideeffects. The subcutaneous form of RELISTOR is approved for use in theU.S., Canada and European Union member states as well as in Iceland,Norway and Liechtenstein. Applications are pending related to thepotential marketing of RELISTOR in Australia and other countries. Inthe area of virology, Progenics is developing the HIV entry inhibitorPRO 140, a humanized monoclonal antibody targeting the entryco-receptor CCR5, which has completed phase 1b clinical studies withpositive results. PRO 140 is currently in phase 2 clinical testing.Pre-clinical programs for the development of novel HCV entryinhibitors are also underway. In the area of oncology, the Company isdeveloping a human monoclonal antibody-drug conjugate (ADC) for thetreatment of prostate cancer - a selectively targeted cytotoxicantibody directed against prostate-specific membrane antigen (PSMA).PSMA is a protein found on the surface of prostate cancer cells aswell as in blood vessels supplying other solid tumors. Progenics isalso developing vaccines designed to treat prostate cancer bystimulating an immune response to PSMA.

    PROGENICS DISCLOSURE NOTICE: The information contained in thisdocument is current as of July 3, 2008. This press release containsforward-looking statements. Any statements contained herein that arenot statements of historical fact may be forward-looking statements.When the Company uses the words "anticipates," "plans," "expects" andsimilar expressions, it is identifying forward-looking statements.Such forward-looking statements involve risks and uncertainties whichmay cause the Company's actual results, performance or achievements tobe materially different from those expressed or implied byforward-looking statements. Such factors include, among others, theuncertainties associated with product development, the risk that
clinical trials will not commence or proceed as planned, the risks anduncertainties associated with dependence upon the actions of ourcorporate, academic and other collaborators and of governmentregulatory agencies, the risk that our licenses to intellectualproperty may be terminated because of our failure to have satisfiedperformance milestones, the risk that products that appear promisingin early clinical trials do not demonstrate efficacy in larger-scaleclinical trials, the risk that we may not be able to manufacturecommercial quantities of our products, the uncertainty of futureprofitability and other factors set forth more fully in the Company'sAnnual Report on Form 10-K for the fiscal year ended December 31,2007, and other reports filed with the Securities and ExchangeCommission, to which investors are referred for further information.In particular, the Company cannot assure you that any of its programswill result in a commercial product. Progenics does not have a policyof updating or revising forward-looking statements and assumes noobligation to update any forward-looking statements contained in thisdocument as a result of new information or future events ordevelopments. Thus, it should not be assumed that the Company'ssilence over time means that actual events are bearing out asexpressed or implied in such forward-looking statements.

    Editor's Note:

    Additional information on Wyeth is available athttp://www.wyeth.com

    Additional information on Progenics is available athttp://www.progenics.com

    --30--TM/ny*

    CONTACT: Wyeth:
             Media:
             Sal Foti, 484-865-3490
             or
             Douglas Petkus, 484-865-5140
             or
             Investor:
             Justin Victoria, 973-660-5340
             or
             Progenics Pharmaceuticals, Inc.:
             Investor:
             Corporate Affairs
             Richard W. Krawiec, Ph.D., 914-789-2814
             rkrawiec@progenics.com
             or
             Dory A. Lombardo, 914-789-2818
             dlombardo@progenics.com
             or
             Media:
             WeissComm Partners
             Aline Schimmel, 312-284-4706


[来源:文传商讯  编辑:徐超]
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