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Apr-25-2008US Allows Sale of Drug to Treat Constipation(topic overview)
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SAN FRANCISCO (Thomson Financial) - Wyeth Pharmaceuticals and Progenics Pharmaceuticals Inc. said Thursday they have received a positive opinion for Relistor subcutaneous injection from the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency. [1] Wyeth said it expects to make Relistor available in the United States in early June. Earlier Thursday, the companies said they received a positive opinion for Relistor from the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency.[2]
Wyeth, a Madison, N.J. , biopharamceutical company said the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, is responsible for reviewing medicinal product applications for safety, quality and efficacy.[3]
Oral and intravenous forms are under development, and the companies are studying other uses. The drug, cleared by Canada in March, is the first approved product for Progenics, which saw its shares rise nearly 33 percent to close at $10.64 on Thursday as Relistor received a positive opinion from a European committee. [4] Shares of Progenics Pharmaceuticals Inc. surged $2.61, or 32.5 percent, today as the Eastview-based biotechnology company announced that regulators in Europe offered a positive opinion of a product candidate that would treat constipation in certain patients.[5]
SAN FRANCISCO (Thomson Financial) - Wyeth Pharmaceuticals and Progenics Pharmaceuticals Inc. late Thursday said the Food and Drug Administration has approved Relistor subcutaneous injection for the treatment of opioid-induced constipation in certain patients with advanced illness.[2] The drug, known under the brand Relistor, is sold by a partnership of New Jersey drug giant Wyeth and Tarrytown, N.Y. -based Progenics Pharmaceuticals Inc., which bought the rights to develop the medicine in 2001. A decision on whether the drug will be approved by the U.S. Food and Drug Administration could come by the end of this month, Progenics said.[6]
WASHINGTON, April 24 (Reuters) - Wyeth (WYE.N: Quote, Profile, Research ) and Progenics Pharmaceuticals Inc (PGNX.O: Quote, Profile, Research ) won U.S. approval to sell a new drug to relieve the constipation that often occurs with use of morphine or other opioid painkillers, regulators said on Thursday.[4]
Relistor acts by blocking opioid entrance into the cells thus allowing the bowels to continue to function normally. "This new drug will be helpful to patients who experience severe constipation associated with the continuous use of morphine or other opioids, which are an important part of care for patients with late-stage, advanced illness." said Joyce Korvick, M.D., deputy director of the Division of Gastroenterology Products, FDA.[7] Recently, Health Canada, the government agency that approves drugs in that country, approved Relistor for use via injection under a patient's skin. So-called opioid-based pain medications such as Oxycontin and morphine are taken by more than 1.5 million people suffering from advanced illnesses such as cancers, but those drugs can produce side effects such as constipation. "This solves an important clinical problem for some of our most vulnerable patients," said Dr. Jonathan Moss, professor of anesthesia and critical care at University of Chicago.[6] The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.[7] RELISTOR is indicated for the treatment of opioid-induced constipation in patients with advanced illness receiving palliative care, when response to laxatives has not been sufficient. It is the first pharmaceutical product approved for this indication in the U.S. To participate in the live call by telephone, please dial (888) 213-3926 from the U.S. or +1 (913) 312-1431 for international callers.[8]
The prescription drug, Relistor, is the first medicine approved to treat opioid-induced constipation.[4]
CHICAGO - A drug to treat opioid-induced constipation in patients with advanced illnesses such as cancer has been approved for marketing in Canada.[6]
The stock was already up nearly 19% from Monday's open prior to Thursday's rally, as investors showed enthusiasm for the prospects of Wyeth WYE and Progenics' Relistor for treatment of constipation induced by pain-killers in patients who are receiving palliative care. The Food and Drug Administration is expected to make a decision on the drug -- previously delayed from January of this year -- on or by April 30.[9] Wyeth and Progenics are seeking approval of Relistor in Europe for the treatment of opioid-induced constipation in advanced-illness patients.[1]
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).[8]
The replay will be available through May 26, 2008. About RELISTOR Subcutaneous Injection 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.[8] Opioids provide pain relief by specifically interacting with mu-opioid receptors within the central nervous system (CNS) ' the brain and spinal cord. 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.[8]
In clinical studies, RELISTOR significantly decreased the constipating effects of opioids without interfering with pain relief.[10]
Common side effects include abdominal pain, gas, nausea, dizziness and diarrhea. If severe diarrhea, vomiting, nausea or abdominal pain occurs while taking Relistor, patients should discontinue use of the medication in consultation with their health care professional. [7] Use of RELISTOR beyond four months has not been studied. (PGNX-G) About the Company 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.[8] 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. DISCLOSURE NOTICE: The information contained in this document is current as of April 24, 2008. Such factors include, among others, the uncertainties associated with product development, the risk that clinical trials will not commence 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 product candidates 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 U.S. Securities and Exchange Commission, to which investors are referred for further information. The Company cannot assure you that any of its programs will result in a commercial product.[8]
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) will hold a conference call tomorrow at 10:00 AM Eastern Time to discuss the U.S. Food and Drug Administration's approval of RELISTORTM (methylnaltrexone bromide) for subcutaneous injection.[8] Progenics and Wyeth Pharmaceuticals are seeking to develop and market the drug, called Relistor.[5]
Shares of Madison, N.J. -based Wyeth rose 13 cents to $44.57, while shares of Tarrytown, N.Y. -based Progenics surged 33% to $10.71.[1] Shares of Wyeth, which has a campus in Pearl River, rose 12 cents to close at $44.56.[5]
On to earnings, Bristol-Myers Squibb BMY earned $661 million, or 33 cents a share, in the first quarter, down from $690 million, or 35 cents a share, in the year prior.[9] Analysts surveyed by First Call/Thomson Financial expected the company to report a loss of $0.30 per share on revenues of $288.54 million for the quarter. The company expects the difficult market conditions to negatively affect its operating results at least through the first half of 2009.[10] On average, six analysts polled by First Call/Thomson Financial expected the company to report earnings of $0.13 per share.[10]
The company reported adjusted profit of 42 cents a share on revenue of $5.18 billion.[9] Adjusted results edged past analysts' estimates, who had pegged profit of 41 cents a share on revenue of $5.12 billion, on average.[9]
Excluding the impact of an $89.4 million writedown, ImClone reported adjusted profit of $29 million, or 33 cents a share, nearly flat with the $29.8 million, or 33 cents a share, it posted a year earlier.[9] On a GAAP basis, ImClone IMCL swung to a loss of $55.9 million, or 65 cents a share, in the recent quarter.[9]
Net Interest Income Before Provision for the first quarter was $21.98 million, up from $21.02 million in the previous year quarter.[10]
First a non-earnings item, Progenics Pharmaceuticals PGNX surged $2.61, or 32.5%, to $10.64 Thursday.[9] Progenics shares then jumped to $12.23 in extended trade in response to the FDA approval.[4]
Opioids are often prescribed on a continuous basis for patients with late-stage, advanced illness to help alleviate pain. This includes patients with a diagnosis of incurable cancer, end-stage Chronic Obstructive Pulmonary Disease (COPD) from emphysema, heart failure, Alzheimer's disease with dementia, HIV/AIDS or other advanced illnesses. Opioids can interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from contracting and pushing out waste products. [7] The content on this site, including news, quotes, data and other information, is provided by Thomson Financial News and its third party content providers for your personal information only, and neither Thomson Financial News nor its third party content providers shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon.[1] The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.[1]
SOURCES
1. Wyeth, Progenics get positive opinion from EMEA panel over Relistor - Forbes.com
2. UPDATE: Wyeth, Progenics say FDA approves Relistor | Latest News | News | Hemscott
3. Wyeth, Progenics Get Positive Opinion For Relistor
4. UPDATE 2-Wyeth, Progenics bowel drug wins US approval | Deals | Regulatory News | Reuters
5. Progenics shares rise on positive opinion | Business in the Burbs
6. Drug to fight constipation from painkillers advances | clarionledger.com | The Clarion-Ledger
7. FDA Approves Relistor for Opioid-Induced Constipation
8. Progenics Pharmaceuticals to Host Conference Call Tomorrow at 10:00 AM Eastern Time to Discuss the Approval of RELISTOR (Methylnaltrexone Bromide) - Nachrichten-Newsticker von Welt Online - st'ndig aktuelle Nachrichten und Informationen - WELT ONLINE
9. Thursdays Health Winners & Losers | Winners & Losers | AZN BMY IMCL IVC PGNX WLP ZMH - TheStreet.com
10. RTTNews - Quick facts Articles, Positive EPS Surprises, News Analysis, Earnings, Audio News.
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