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Progenics and Wyeth Announce FDA Has Approved RELISTOR


    First Drug for Opioid-Induced Constipation to Launch

    in United States
    Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth

    Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that

    the U.S. Food and Drug Administration (FDA) has approved RELISTORâ„¢ (methylnaltrexone bromide) subcutaneous injection for the treatment of

    opioid-induced constipation (OIC) in patients with advanced illness who

    are receiving palliative care, when response to laxative therapy has not

    been sufficient. In clinical studies, RELISTOR significantly decreased

    the constipating effects of opioids without interfering with pain

    relief. Wyeth expects to make RELISTOR available in the United States in

    early June.
    "The approval of RELISTOR is a transformative

    event for Progenics Pharmaceuticals," says

    Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief

    Science Officer, Progenics Pharmaceuticals, Inc. "This

    is our first U.S. product approval. I am proud of what our Company has

    achieved and especially want to thank our patients and investigators who

    participated in the RELISTOR development program. This program has

    greatly benefited from our collaboration with Wyeth to develop and

    commercialize the RELISTOR platform of products."
    Each year, more than 1.5 million Americans receive palliative care due

    to an advanced illness, such as incurable cancer, end-stage heart and

    lung disease, or AIDS. Many of these patients

    are prescribed opioids to manage their pain, and

    experts have stated that constipation that can be debilitating occurs in

    practically all of them.
    "We are pleased to make RELISTOR available to

    patients to address this serious unmet medical need," says Bernard Poussot, President and Chief Executive Officer, Wyeth. "As

    Wyeth´s third new medicine to receive FDA

    approval in 2008, RELISTOR is an excellent example of Wyeth´s

    continuing commitment to develop and deliver medicines that work in

    novel ways and provide important new treatment options for patients."
    Jay Thomas, M.D., Ph.D., an investigator in the subcutaneous RELISTOR

    clinical trial program and Clinical Medical Director of San Diego

    Hospice and the Institute of Palliative Medicine, says: "Opioid

    analgesics are the mainstay therapy for pain management in

    advanced-illness patients receiving palliative care. Side effects

    associated with opioids, such as constipation, can be severe enough to

    limit pain management. I am pleased that we now have a new treatment

    option to provide relief to advanced-illness patients with OIC."
    About RELISTOR and Opioids
    RELISTOR, administered via subcutaneous injection, is a peripherally

    acting mu-opioid receptor antagonist that counteracts the constipating

    effects of opioid pain medications in the gastrointestinal tract without

    affecting their ability to relieve pain.
    Opioids provide pain relief by specifically interacting with mu-opioid

    receptors within the central nervous system (CNS) "“ the brain and spinal cord. However, opioids also interact with mu-opioid

    receptors found outside the CNS, such as those within the

    gastrointestinal tract, resulting in constipation that can be

    debilitating. RELISTOR selectively displaces opioids from the mu-opioid

    receptors outside the CNS, including those located in the

    gastrointestinal tract, thereby decreasing their constipating effects.

    Because of its chemical structure, RELISTOR does not affect the

    opioid-mediated analgesic effects on the CNS. The efficacy and safety

    profile of RELISTOR was established in two phase 3 clinical trials. Use

    of RELISTOR beyond four months has not been studied.
    Important Safety Information for 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 with RELISTOR in clinical trials

    were abdominal pain, flatulence, and nausea.

    RELISTOR Prescribing Information will be 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 for the treatment of

    opioid-induced side effects. In accordance with the terms of the

    collaboration, this U.S. marketing approval triggers a $15 million

    milestone payment to Progenics from Wyeth.
    (PGNX-G)
    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.
    Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a

    biopharmaceutical company focusing on the development and

    commercialization of innovative therapeutic products to treat the unmet

    medical needs of patients with debilitating conditions and

    life-threatening diseases. Principal programs are directed toward

    gastroenterology as well as the treatment of HIV infection and cancer.

    The Company, in collaboration with Wyeth, is developing RELISTOR for the

    treatment of opioid-induced side effects, including constipation (oral

    and subcutaneous formulations) and postoperative ileus (intravenous

    formulation). In the area of HIV infection, the Company is developing

    the viral-entry inhibitor PRO 140, a humanized monoclonal antibody

    targeting the HIV entry co-receptor CCR5, which has completed phase 1b

    clinical studies with positive results. In the area of prostate cancer

    the Company is developing a human monoclonal antibody drug conjugate "“ a selectively targeted cytotoxic antibody directed against

    prostate-specific membrane antigen (PSMA), a protein found on the

    surface of prostate cancer cells. Progenics is also developing vaccines

    designed to stimulate an immune response to PSMA.
    PROGENICS DISCLOSURE NOTICE: The information contained in this

    document is current as of April 24, 2008. This press release contains

    forward-looking statements. Any statements contained herein that are not

    statements of historical fact may be forward-looking statements. When

    the Company uses the words "anticipates," "plans," "expects" and similar expressions, it is identifying forward-looking statements.

    Such forward-looking statements involve risks and uncertainties which

    may cause the Company´s actual results

    performance or achievements to be materially different from those

    expressed or implied by forward-looking statements. Such factors

    include, among others, the uncertainties associated with product

    development, the risk that clinical trials will not commence or proceed

    as planned, the risks and uncertainties associated with dependence upon

    the actions of our corporate, academic and other collaborators and of

    government regulatory agencies, the risk that our licenses to

    intellectual property may be terminated because of our failure to have

    satisfied performance milestones, the risk that products that appear

    promising in early clinical trials do not demonstrate efficacy in

    larger-scale clinical trials, the risk that we may not be able to

    manufacture commercial quantities of our products, the uncertainty of

    future profitability and other factors set forth more fully in the

    Company´s Annual Report on Form 10-K for the

    fiscal year ended December 31, 2007, and other reports filed with the

    Securities and Exchange Commission, to which investors are referred for

    further information. In particular, the Company cannot assure you that

    any of its programs will result in a commercial product. Progenics does

    not have a policy of updating or revising forward-looking statements and

    assumes no obligation to update any forward-looking statements contained

    in this document as a result of new information or future events or

    developments. Thus, it should not be assumed that the Company´s

    silence over time means that actual events are bearing out as expressed

    or implied in such forward-looking statements.
    Editor´s

    Note:
    Additional information on Progenics available at http://www.progenics.com
    Additional information on Wyeth available at http://www.wyeth.com