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Wyeth and Progenics Pharmaceuticals Announce Worldwide Collaboration

Posted on: Friday, 23 December 2005, 06:00 CST

Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that they have entered into an exclusive, worldwide agreement for the joint development and commercialization of methylnaltrexone (MNTX) for the treatment of opioid-induced side effects, including constipation and post-operative bowel dysfunction. These medical conditions are major therapeutic challenges in the management of gastrointestinal function in individuals treated with opioids for pain or in patients following serious or prolonged surgeries.

Under the terms of the collaboration, Wyeth receives worldwide rights to MNTX, and Progenics retains an option to co-promote the product in the United States. The companies will collaborate on the worldwide development of MNTX. The transaction includes an upfront payment of $60 million to Progenics with as much as an additional $356.5 million payable upon achievement of certain milestones. Wyeth will pay Progenics royalties on worldwide sales of MNTX and co-promotion fees within the United States. Additionally, Wyeth is responsible for all future development and commercialization costs.

"MNTX fits well within our current portfolio and represents a broad treatment platform with multiple products intended to address unmet medical needs in opioid-induced bowel disorders," says Bernard Poussot, President of Wyeth Pharmaceuticals and Executive Vice President, Wyeth. "Our collaboration with Progenics strengthens Wyeth's leadership position in the field of gastroenterology. Importantly, within Wyeth, we have selected MNTX for streamlined development."

"Our collaboration with Wyeth maximizes the global development, commercialization, and market potential of MNTX across a broad range of therapeutic indications," says Paul J. Maddon, M.D., Ph.D., Progenics' Founder, Chief Executive Officer and Chief Science Officer. "Progenics and Wyeth share a vision for bringing this important new therapy to market for the millions of patients who suffer from the debilitating side effects of opioid pain medications."

Currently, there are no therapies approved to treat the side effects of opioids. These side effects often prevent optimal pain control and may prolong hospitalization. The ability to deliver MNTX using three dosage forms and routes of administration represents a significant benefit to patients and health care professionals. Each MNTX dosage form is tailored to address the needs of specific clinical applications based on onset of action, predictability of response, dosing flexibility and ease of use. The three MNTX product candidates are:

-- Subcutaneous injection for the treatment of intractable constipation in patients with advanced medical illness (AMI), including cancer and AIDS;

-- Intravenous infusion for the treatment of patients with gastrointestinal tract and urinary dysfunction that commonly occurs after major abdominal and prolonged surgeries; and

-- Oral formulation for the treatment of opioid-induced constipation in patients with chronic pain, including those suffering from headaches, joint pain, lower-back pain, sickle-cell disease, muscle pain and other disorders requiring opioid analgesics.

Progenics is completing a second pivotal phase 3 clinical study of subcutaneous MNTX in AMI. In 2006, clinical studies in post-operative bowel dysfunction with intravenous MNTX are scheduled to enter phase 3, and the oral product will enter phase 2 in patients receiving opioids for chronic pain. Under the terms of the collaboration, Wyeth will develop oral MNTX worldwide. Progenics will lead the U.S. development of subcutaneous and intravenous MNTX, while Wyeth will lead development of these parenteral products outside the U.S. Wyeth and Progenics will pursue an integrated strategy to optimize worldwide development, regulatory approval, and commercial launch of the three MNTX products which may impact timelines previously disclosed by Progenics. Decisions regarding the timelines for development of the three MNTX products will be made by the Joint Development Committee, consisting of members from both Wyeth and Progenics.

Background

Opioids are widely used to lessen suffering in advanced cancer and other terminal diseases. To relieve pain, narcotic medications such as morphine activate specific opioid receptors located in the central nervous system - the brain and spinal cord. Opioids, however, also interact with these receptors outside of the central nervous system, resulting in side effects, which can be debilitating, including constipation, urinary retention and severe itching. MNTX is designed to block peripheral opioid receptors whose activation causes these side effects. As MNTX does not cross the blood-brain barrier, it does not interfere with brain-centered pain relief.

-- Advanced medical illness: Approximately 1.7 million patients suffer from AMI each year in the U.S., including patients with cancer, AIDS, sickle-cell disease and other painful terminal illnesses. The majority of those treated with opioids for pain suffer debilitating constipation.

-- Post-operative bowel dysfunction: More than 20 million surgeries occur in the U.S. each year, with more than two-million patients at high risk for developing post-operative bowel dysfunction, a serious paralysis of the gastrointestinal tract. Post-operative bowel dysfunction is a major factor in increasing hospital stay, as patients are typically not discharged until bowel and urinary functions are restored.

-- Chronic pain: Approximately five-million patients receive opioids on a chronic basis, and many experience chronic opioid-induced constipation.

Company Profiles

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.

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 symptom management and supportive care and the treatment of HIV infection and cancer. The Company has four product candidates in clinical development and several others in preclinical development. The Company, in collaboration with Wyeth, is developing methylnaltrexone (MNTX) for the treatment of opioid-induced side effects, including constipation and post-operative bowel dysfunction. In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV coreceptor CCR5 (in phase 1b studies). In addition, the Company is conducting research on ProVax, a novel prophylactic HIV vaccine. In collaboration with Cytogen Corporation, the Company is developing immunotherapies for prostate cancer, including a human monoclonal 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. A recombinant PSMA vaccine is in phase 1 clinical testing. The Company is also developing a cancer vaccine, GMK, in phase 3 clinical trials for the treatment of malignant melanoma.

WYETH DISCLOSURE NOTICE: The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing, commercialization, 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, wars or terrorist acts, product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

PROGENICS DISCLOSURE NOTICE: The information contained in this document is current as of December 23, 2005. 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 risk that we will not be able to obtain funding necessary to conduct our operations, the uncertainties associated with product development, the risk that clinical trials will not commence, proceed or be completed 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 are later found not to work effectively or are not safe, the risk that we may not be able to manufacture commercial quantities of our products, the risk that our products, if approved for marketing, do not gain market acceptance sufficient to justify development and commercial costs, 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, 2004 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

Progenics Pharmaceuticals issued two press releases today. The other release is entitled: Progenics Acquires Methylnaltrexone Rights from Licensors and Plans to File Shelf Registrations

Source: Business Wire

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