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Apr-26-2008Progenics' Double Dose of Good News(topic overview)
CONTENTS:
- The biopharmaceutical company said late Thursday that funding for the buyback will come from a $15 million milestone payment from Wyeth related to Food and Drug Administration approval of the companies' constipation drug Relistor. (More...)
- The stock finished at $10.64 Thursday. (More...)
- Though European regulators gave a thumbs up to the drug on Thursday, some U.S. analysts doubted Relistor would gain FDA approval. (More...)
- "The approval of Relistor is a transformative event for Progenics Pharmaceuticals," says Paul J. Maddon, CEO of Progenics. (More...)
- Called Relistor, the injectable drug relieves constipation in patients who receive pain-relief medication for severe pain associated with cancer and other severe diseases. (More...)
- Daleco Resources Corp., a mining and drilling company in West Chester, said it applied with two partners for U.S. Forest Service approval of a planned open-pit clay mine in New Mexico's Gila National Forest. (More...)
- Progenics is also studying the oral formulation of the drug in a mid-stage trial for OIC in chronic pain patients. (More...)
- The revenue growth was spurred on by antidepressant Effexor, which rose 15%, and rheumatoid arthritis drug Enbrel, which jumped 36% to $606 million outside North America. (More...)
- The sponsors, Wyeth Pharmaceuticals Inc., carried out clinical studies which demonstrated the safety and effectiveness of Relistor. (More...)
- Wyeth said the Committee's approval for Relistor will be forwarded to the European Commission for a final decision, expected by mid-year. (More...)
- The medicine is the first to stop morphine-like drugs from interfering with bowel movements, while allowing the drugs to continue blocking pain. (More...)
- Based on revised DCF analysis, we are raising our 12-mo target price to $9.50 from $9." (More...)
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The biopharmaceutical company said late Thursday that funding for the buyback will come from a $15 million milestone payment from Wyeth related to Food and Drug Administration approval of the companies' constipation drug Relistor. Progenics' Relistor injection for opiate-induced constipation was approved by the FDA for use in patients with advanced illnesses who are receiving treatment to lessen their pain, when laxatives haven't been sufficient. [1] NEW YORK (Associated Press) - Progenics Pharmaceuticals Inc. and partner Wyeth said Friday their Relistor injection for opiate-induced constipation has been approved by the Food and Drug Administration. The drug has been cleared for use in patients with advanced illnesses who are receiving treatment to lessen their pain, when laxatives haven't been sufficient.[2] Compared with the first quarter of 2007, earnings were up 14 percent and sales were up 33 percent. The firm announced Thursday that it had received Food and Drug Administration approval to market its ADHD drug for adults. Progenics Pharmaceuticals Inc. and Wyeth Pharmaceuticals said their jointly developed medicine to relieve opioid constipation among dying patients has been approved by the Food and Drug Administration. Progenics, Tarrytown, N.Y., and Wyeth, Collegeville, said they expected the drug, Relistor, to go on the market in June.[3] 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.[4] Shares of Eastview-based Progenics Pharmaceuticals Inc. shot up again this morning after the company and Wyeth Pharmaceuticals Inc. announced the U.S. Food and Drug Administration approved an application to market a drug for constipation in patients taking certain pain medications.[5] Shares of Progenics Pharmaceuticals Inc. closed Friday at $13.40 per share rising 25.94 percent, and climbed to $13.75 on after trading as its drug Relistor was approved in the U.S. by the Food and Drug Administration. Get stories by e-mail on this topic.[6] Shares of Progenics Pharmaceuticals have been surging in early trading after the Food and Drug Administration approved constipation drug Relistor, which is developed with Wyeth opnbrktWYEclsbrkt.[7] NEW YORK (AP) _ Progenics Pharmaceuticals surged in premarket trading after the Food and Drug Administration approved Relistor, a constipation drug Progenics developed with Wyeth. NEW YORK (AP) _ A Lehman Brothers analyst started coverage of RadioShack Corp. with an "Underweight" rating, saying the electronics retailer is unlikely to improve its sales over the course of the year.[8]
BioWorld Today - Apr. 28, 2008 The FDA has approved Progenics Pharmaceuticals Inc.' s Relistor for constipation due to the use of powerful painkillers in patients with incurable cancer and other advanced-stage diseases. This marks Progenics' first U.S. approved product, triggering a $15 million milestone payment from partner Wyeth.[9] Looking forward, a couple of upcoming events could drive Wyeth's stock price. Next week the company should hear back from the FDA about its opioid-induced constipation (OIC) drug, which it will market with Progenics Pharmaceuticals ' (Nasdaq: PGNX ). The drug recently failed as a treatment for postoperative ileus (POI), but it still has a good chance of being approved this month for OIC. Investors should also be on the lookout for phase 2 data for Alzheimer's treatment bapineuzumab in the middle of this year.[10] • Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX ), up 25.9% after the Tarrytown, N.Y. -based company's constipation drug won FDA approval.[11]
Shares of Eastview-based Progenics Pharmaceuticals Inc. soared again yesterday after the company won its first U.S. approval for a product, a drug to ease constipation from painkillers given to the terminally ill.[12] Shares of Progenics Pharmaceuticals Inc. jumped as much as 25 percent in trading this morning after the biopharmaceutical company said it had received U.S. regulators' approval to begin selling its first drug.[13] BANGALORE (Reuters) - Shares of Progenics Pharmaceuticals (PGNX.O: Quote, Profile, Research ) rose as much as 48 percent, a day after the company's bowel drug, Relistor, won U.S. approval and received a positive opinion from European health regulators.[14]
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.[15] 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.[16] NEW YORK (Associated Press) - Progenics Pharmaceuticals Inc. said its board approved a buyback of up to $15 million shares of its common stock.[1] The companies said Relistor significantly decreased the constipating effects of opioids without interfering with pain relief. Wyeth shares were trading at $45.10 this morning on the New York Stock Exchange, up from yesterday's close of $44.56.[17] Wyeth shares were up 24 cents at $44.80 in afternoon trade on the New York Stock Exchange.[14]
The stock finished at $10.64 Thursday. Citi analyst Yaron Werber upgraded Progenics stock to "Hold" from "Sell," saying he did not expect the FDA to approve Relistor. He raised his profit and sales estimates, and increased his target price to $13 per share from $4. [18] Citigroup analyst Yaron Werber upgraded the stock to "hold" from "sell," calling the approval from the U.S. Food and Drug Administration a "pleasant surprise". In March, Progenics shares lost almost two-thirds of their value after the drug failed a late-stage trial for another bowel condition -- post-operative ileus (POI). At that time, Werber had doubted that the drug would be approved in April and had cut the stock's rating.[14] 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.[19] Relistor (methyl naltrexone bromide), which helps restore bowel function in patients who are in the late stages of advanced illness and receive opioids continuously for pain relief, has been approved by the Food and Drug Administration (FDA).[20]
FRIDAY, April 25 (HealthDay News) -- The U.S. Food and Drug Administration has approved Relistor (methylnaltrexone bromide) to treat constipation stemming from continuous use of opioid painkillers.[21]
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.[22] The Food and Drug Administration approval of Relistor _ made by drugmaker Wyeth and partner Progenics Pharmaceuticals Inc. _ could provide relief for a common problem for patients dying of cancer and other painful diseases.[23] The drug is the result of a 2005 agreement struck between Eastview-based Progenics and Wyeth Pharmaceuticals, a unit of Madison, N.J. -based Wyeth that employs about 3,200 workers in Pearl River. Its approval by the Food and Drug Administration will result in a $15 million milestone payment to Progenics by Wyeth, per the agreement.[13]
"The approval of Relistor is a transformative event for Progenics," Dr. Paul Maddon, chief executive officer Progenics, said in a statement. Progenics will receive a $15 million payment from its partner, Wyeth, because of the approval. The approval will give Progenics and Wyeth, which has a campus in Pearl River, a head start against a competing drug being developed by Adolor Corp. and GlaxoSmithKline PLC. Last April in a clinical trial, their product, Entereg, was linked to an increased risk of fractures, benign and malignant tumors, and heart attacks.[12]
'''The approval of Relistor is a transformative event for Progenics Pharmaceuticals,''' Dr. Paul J. Maddon, the company'''s chief executive, said. '''This is our first U.S. product approval.''' The company said more than 1.5 million Americans each year receive pain medication due to advanced illnesses such as cancer, end-stage heart and lung disease and AIDS. Many of these patients receive opiods for the pain and experts have found serious constipation strikes nearly all of them, the company said.[5] The marketing approval triggers a $15 million milestone payment to Progenics from Wyeth. The companies said more than 1.5 million Americans receive pain treatment each year due to an advanced illness, such as incurable cancer, end-stage heart and lung disease, or AIDS. Many are prescribed opiates to manage their pain, such as morphine, and the constipation that ensues can be debilitating.[2] "Side effects associated with opioids, such as constipation, can be severe enough to limit pain management," Dr. Jay Thomas of San Diego Hospice and the Institute of Palliative Medicine, who participated in testing of the drug, said in a statement. Petkus said up to 1.8 million Americans who receive pain treatment each year for an advanced illness, such as AIDS, incurable cancer or end-stage heart and lung disease, suffer from sometimes-debilitating constipation from opiate use. About 230 million prescriptions were written for opiates in the United States last year, he said. Opiates relieve pain by interacting with receptors in the brain and spinal cord, but they also interact with receptors elsewhere in the body, such as in the gastrointestinal tract, which can cause constipation. Relistor blocks opiates from interacting with receptors outside the central nervous system, decreasing their constipating effects but not lessening pain relief.[23]
Relistor, by blocking opioid entrance into the cells, allows the bowels to continue working properly. Joyce Korvick, M.D., Deputy Director, Division of Gastroenterology Products, FDA, said "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."[20] There's a big sigh of relief coming from Wyeth and Progenics today as the FDA approved Relistor, a subcutaneous injection for opioid-induced constipation in patients with advanced illness who are receiving palliative care.[24] Relistor (methylnaltrexone bromide for SC injection, from Progenics and Wyeth) has been approved for the treatment of opioid-induced constipation (OIC) in palliative care patients with advanced illness, when response to laxative therapy has been insufficient.[25]
Wyeth and Progenics are seeking approval of Relistor in Europe for the treatment of opioid-induced constipation in advanced-illness patients.[26]
Soon after European regulators announced the approval Thursday afternoon of Relistor, the bowel drug from Progenics PGNX and Wyeth WYE, Citibank analyst Yaron Werber pushed out to clients a reiteration of his sell rating and $4 price target on Progenics. In his note, Werber insisted that despite European approval, regulators in the U.S. would not approve Relistor.[27] Analysts are expecting revenue of $66.5 billion and EPS of $2.10. In regulatory news, Progenics Pharmaceuticals PGNX and Wyeth WYE said late Thursday that they received U.S. approval for Relistor.[28] Regulatory actions and earnings nudged a few health stocks on an otherwise flat end to the week Friday. In regulatory news, Progenics Pharmaceuticals PGNX and Wyeth WYE said late Thursday that they received U.S. approval for Relistor.[29]
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.[15]
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.[26] COLLEGEVILLE, Pa., April 23 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that it is withdrawing its application for an extension to the European Marketing Authorization for TYGACIL(R) (tigecycline). This extension sought approval of TYGACIL for the treatment of community-acquired pneumonia (CAP). Wyeth's action is based on its understanding of the Committee for Medicinal Products for Human Use (CHMP) assessment that the TYGACIL CAP pivotal clinical trials did not include a sufficient number of severely ill CAP patients to alleviate reviewer concerns regarding efficacy in this subpopulation.[30] Progenics and marketing partner Wyeth (NYSE: WYE ) received a positive recommendation from the Committee for Medicinal Products for Human Use, which advises the European Medicines Agency on which drugs to approve.[31]
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.[4] The European Committee for Medicinal Products for Human Use gave the treatment a positive opinion as well. Relistor 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, the companies explain.[32]
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.[33]
Wyeth plans to use as many as 1,100 sales representatives to promote the drug, said George Farmer, an analyst with Wachovia Capital Markets in New York. "The effort could lead to a quick uptake of Relistor, given the unmet medical need and enthusiasm for this product by hospice care workers," Farmer said yesterday in a note to clients.[12] The drug previously was approved for sale in Canada, on April 1. Wyeth won approval for its antidepressant Pristiq, the drug maker's planned successor to its blockbuster Effexor, on Feb. 29. It got FDA approval on Feb. 1 for Xyntha, a genetically engineered clotting medicine to prevent and control bleeding in people with hemophilia. That snapped a streak in which the FDA four straight times either rejected a Wyeth experimental drug, demanded more data or required an entire new study. AP Business Writer Jennifer Malloy in New York contributed to this report.[23]
As I wrote at the end of March when Progenics was trading below $6 and near cash, investors were giving no value at all to Relistor (also known as methylnaltrexone). That didn't seem right. Sure, Relistor had its share of setbacks, but in this case the clinical data made a reasonable case for FDA approval.[27] Progenics shares then jumped to $12.23 in extended trade in response to the FDA approval.[15]
In other green-light news, Gilead GILD said Friday that the European Commission granted the company marketing approval for Viread in chronic hepatitis B. Gilead's shares added 47 cents, or 0.9%, to $51.49 on Friday. Genzyme GENZ and Isis ISIS said FDA requirements will result in some delays for Mipomersen, the cholesterol-lowering antisense drug at the heart of their joint venture deal announced in January.[29] The subcutaneous injection may be used in patients with advanced illness when response to laxative therapy has not been sufficient. Wyeth notes that this is its third new drug that the FDA has sanctioned this year. In January the company reported U.S. launch of a generic version of Protonix, its own GERD therapy.[32] "In October 2007, the U.S. Food and Drug Administration (FDA) accepted the filing of our supplemental New Drug Application for TYGACIL for the treatment of patients with CAP. We believe that the clinical trial data submitted to the FDA, as well as other regulatory authorities around the world, demonstrate the safety and efficacy of TYGACIL for the proposed CAP indication." The FDA is currently reviewing this application and a decision is expected during the second quarter of 2008.[30] The Food and Drug Administration approved the drug for pain-killer-induced constipation in patients who are receiving palliative care, when laxative therapy was unsuccessful.[29]
The medicine is able to stop morphine-like drugs from interfering with bowel movements while allowing the drugs to continue blocking pain. Relistor may have side effects such as abdominal pain, gas, nausea, dizziness and diarrhea, the Food and Drug Administration agency said. Its price wasnt disclosed however the companies expect the product will be launched to the market in June.[6] A few hours later, Thursday evening, the U.S. Food and Drug Administration announced the approval of Relistor.[27] Approval by the U.S. Food and Drug Administration was announced Thursday after the markets closed.[12]
Though European regulators gave a thumbs up to the drug on Thursday, some U.S. analysts doubted Relistor would gain FDA approval. [24] Then the stock jumped more than 30% in the other direction yesterday after the drug was recommended for approval in the European Union for treating opioid-induced constipation (OIC), and is trading up another 26% today after the FDA approved it last night.[31] ROCKVILLE, Md., April 25 -- The FDA has approved methylnaltrexone bromide (Relistor) injection for treatment of opioid-induced constipation, a common condition among patients on continuous medication for pain relief in late-stage illness.[34] The FDA yesterday approved a drug called Relistor to relieve constipation in very sick patients taking powerful painkillers.[35]
The FDA is reviewing Entereg and has a May 10 deadline to decide whether to approve it, Adolor has said. The Progenics drug, an injection, is approved for patients near the end of their lives who are taking chronic opioid painkillers, the FDA said.[12]
The arrival of the drug, co-marketed by Wyeth and Progenics, is one more sign that the health-care world is paying more attention to easing symptoms in dying patients. As the WSJ reported last year, Relistor (generic name: methylnaltrexone) was tested on hospice patients, most of whom were in the final months of their lives. The drug blocks opioids, such as morphine, from entering cells involved in bowel function without interfering with pain relief.[35] The patients were getting lots of opioid pain meds, which often cause constipation. The "greatest medical need for a drug like this is in patients at the end of life," Progenics' CEO told the WSJ then.[35]
Wyeth expects to make Relistor available in the U.S. in June, spokesman Doug Petkus said. Relistor was approved specifically for patients with advanced illnesses who are receiving opiates such as morphine to lessen their pain _ and are suffering from constipation that laxatives aren't relieving sufficiently.[23] FDA gave Progenics Pharmaceuticals and Wyeth Pharmaceuticals the go-ahead to market Relistor''' for opioid-induced constipation.[32] The FDA approval for Relistor is the third in just nine weeks for Madison, N.J. -based Wyeth, but the first ever for Progenics, of Tarrytown, N.Y.[23]
Wyeth expects sales to start in early June, and it will pay Tarrytown, N.Y. -based Progenics $15 million as a result of the approval.[18] The marketing approval triggers a $15 million milestone payment to Progenics from Wyeth.[23] Wyeth, which has a campus in Pearl River, will make a $15 million payment to Progenics as a result of the approval.[5]
Under the agreement established between the companies in December 2005, Progenics will receive $15 million. Progenics''' board approved a share-repurchase program to acquire up to $15 million of its outstanding common shares using this milestone fee.[32] Progenics Pharmaceuticals Inc. shares jumped $2.86, or 26.9 percent, to $13.50 in premarket trading.[18] Progenics shares shot up 26 percent, or $2.76, to $13.40, while Wyeth shares increased 41 cents, to $44.97.[23] 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.[26] Shares of Madison, N.J. -based Wyeth closed the regular session up 12 cents at $44.56, while shares of Tarrytown, N.Y. -based Progenics finished up 33% at $10.64.[4]
In last year's first quarter, the company earned $2.1 million, or 20 cents per share.[3] Republic First Bancorp Inc. said a higher loan-loss provision stemming from the declining housing market caused it to post a loss of $2.8 million, or 26 cents per share, for the first quarter. The Philadelphia holding company for Republic First Bank said the increase in its loss provision and other charges amounted to $4.4 million, or 41 cents per share.[3]
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.[36]
On average, six analysts polled by First Call/Thomson Financial expected the company to report earnings of $0.13 per share.[36]
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.[22] On a GAAP basis, ImClone IMCL swung to a loss of $55.9 million, or 65 cents a share, in the recent quarter.[22]
Immunicon Corp., a medical-technology firm in Huntington Valley, said it will be delisted by Nasdaq on Monday. The firm's shares have declined from $2.64 on April 25, 2007, to 22 cents today, reducing its market capitalization to $6.64 million, far below the Nasdaq minimum of $25 million. In an SEC filing, the firm said it would not appeal the delisting and would pursue quotation of its common stock on the Over-the-Counter Bulletin Board.[3] 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.[22] The company, which operates the Wilmington Savings Fund Society, earned $7.2 million, or $1.15 per share, compared with $7.8 million, also $1.15 per share, in the same period a year ago.[3]
Amsellem estimated peak worldwide sales of about $250 million for use in patients with advanced illness, while Cowen and Company analyst Steve Scalia forecast sales reaching $210 million a year in 2012.[23] The drug may generate $300 million in peak U.S. sales, George Farmer an analyst at Wachovia said according to Bloomberg. This article is copyrighted by International Business Times.[6] The product may generate $300 million in peak U.S. sales, Farmer said. The drug's price wasn't disclosed today in a conference call with Progenics executives, though it will be available before the product is introduced in June, he said.[12]
Shire P.L.C. said it earned $128.6 million on sales of $702 million in the first quarter. The British pharmaceutical firm, maker of top-selling Adderall XR for attention-deficit/ hyperactivity disorder, has its U.S. headquarters in Wayne.[3]
The only thing worse for a pharmaceutical company than generic competition is generic competition that it didn't prepare for. Such was the case for Wyeth (NYSE: WYE ) in the first quarter as it scrambled to deal with generic competition from Teva Pharmaceuticals (Nasdaq: TEVA ) against its heartburn drug Protonix, which Wyeth believes is still under patent.[10]
Wyeth and its partner Elan (NYSE: ELN ) have already begun a phase 3 trial of the drug based on the interim results from the phase 2 trial, so anything less than stellar results may be a letdown. Wyeth is looking for adjusted EPS of $3.35 to $3.49 this year, which might fall just shy of last year's number. Given the loss of exclusivity for one of its main drugs, that sounds like a win in my book.[10]
Progenics and Wyeth Pharmaceuticals are seeking to develop and market the drug, called Relistor.[16] More than any other industry, drug development contains the most "what have you done for me lately" investors. Witness Progenics Pharmaceuticals (Nasdaq: PGNX ), which dropped more than 60% when its lead drug, Relistor, failed a phase 3 trial last month for postoperative ileus, a constipation-like condition that follows abdominal surgery.[31]
First a non-earnings item, Progenics Pharmaceuticals PGNX surged $2.61, or 32.5%, to $10.64 Thursday.[22] Progenics Pharmaceuticals, Inc. PGNX $13.40 +2.76 (+25.94%)[31]
"The approval of Relistor is a transformative event for Progenics Pharmaceuticals," says Paul J. Maddon, CEO of Progenics. "This is our first U.S. product approval. [24] Shares surged 73 cents, or 13 percent, to $6.19, the biggest increase since Feb. 26. The U.S. Commerce Department is imposing a 5 percent tariff on sock imports from Honduras for six months, meeting the demands of domestic producers who say the overseas products are harming their business.[3] The companies said Relistor significantly decreased the constipating effects of opioids without interfering with pain relief. WSFS Financial Corp., Wilmington, raised its quarterly dividend 2 cents, or 20 percent, to 12 cents per share. The bank said it boosted the dividend despite a 7.7 percent decline in first-quarter net income because its capital position improved.[3]
Opioids are commonly given continuously to patients with late-stage advanced illness for pain relief. This includes people with terminal cancer, end-stage COPD (Chronic Obstructive Pulmonary Disease) from emphysema, heart failure, Alzheimer's disease with dementia, HIV/AIDS, and some others. Opioids often relax the intestinal smooth muscles to such an extent that they do not contract and push waste products out.[20] 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.[19]
Called Relistor, the injectable drug relieves constipation in patients who receive pain-relief medication for severe pain associated with cancer and other severe diseases. [13] The prescription drug, Relistor, is the first medicine approved to treat opioid-induced constipation.[15] TRENTON, N.J. - Federal regulators have approved the first drug meant to relieve constipation caused by narcotic painkillers, the drug's makers said Friday.[23]
The market may be relatively small, but for Progenics, which didn't have any approved drugs until now, any sales are better than none.[31] The stock had gained 33 percent Thursday on a recommendation that the drug, Relistor, be cleared for sale in Europe.[12] Oops. Werber is a good guy and a smart analyst, so I don't mean to mock him for making a bad call on Progenics and Relistor. Heck, everyone makes mistakes, and this time Werber wasn't alone. Cowen & Co. analyst Leland Gershell, for instance, did exactly the same thing Thursday afternoon, except he had a neutral rating on the stock -- not a sell.[27] Citigroup analyst Yaron Werber upgraded Progenics stock to "hold" from "sell" and called the approval a pleasant surprise, Reuters noted.[6]
When news of the FDA approval hit the wires after hours, the stock jumped another 20% to $12.75.[27] Keep up to speed with the latest biotechnology trends, breakthroughs and FDA approval news.[24]
Daleco Resources Corp., a mining and drilling company in West Chester, said it applied with two partners for U.S. Forest Service approval of a planned open-pit clay mine in New Mexico's Gila National Forest. The companies say they hope to sell materials extracted from the Sierra Kaolin mine to the coatings, fillers and pigments sectors of the paper and paint industries. [3] The drug, which should be available in the U.S. by early June, according to Wyeth, represents Progenics''' first U.S. approval.[32] The companies announced the approval of Relistor last night. Earlier in the day, they announced that regulators in Europe had offered a positive opinion of the drug.[5] Friedman, Billings, Ramsey analyst David Amsellem wrote in a note to investors Friday that patients with advanced illnesses are the smallest market of three possible uses for which the companies have been testing the drug.[23] The FDA-approved prescribing information doesn't call for patients to register to use the drug, Alan Carr, an analyst with Needham & Co. in New York, said in a note to clients.[12]
NEW YORK (AP) _ Analysts took differing views on American Express Co.' s earnings and stock potential Friday, the day after the credit card company said lagging customer payments ate into first-quarter profit.[8]
NEW YORK (AP) _ Shares of Baidu.com are rising in Friday premarket trading after the Chinese search engine operator reported greater-than-expected revenue for the first quarter, and forecast similar results for the second quarter.[8] Ericsson shares were up $2.93, or 13.5%, to $24.63. Microsoft MSFT shed $1.97, or 6.2%, to $29.83 after its third-quarter results and updated forecast Thursday failed to live up to the Street's high expectations. Revenue for its third quarter was flat at $14.45 billion and in line with analysts' expectations of $14.5 billion.[28] Adjusted results edged past analysts' estimates, who had pegged profit of 41 cents a share on revenue of $5.12 billion, on average.[22] The company reported adjusted profit of 42 cents a share on revenue of $5.18 billion.[22]
Net income fell 11% to $4.39 billion, or 47 cents a share, from $4.93 billion, or 50 cents a share, in the year-ago period. It beat analysts' EPS expectations of 44 cents.[28] Analysts were expecting revenue of $203.7 million and earnings of 38 cents a share.[28] Analysts had expected adjusted earnings of $1.05 a share on revenue of $3.624 billion.[29]
Tenet Healthcare Corp. shares gained the most in two months after Credit Suisse analyst Ken Weakley, who last year predicted a bankruptcy filing, recommended buying the shares and raised the target price to $8 from $6.[3]
Shares of Wyeth, which has a campus in Pearl River, rose 12 cents to close at $44.56.[16] Wyeth was trading up 27 cents, or 0.6%, at $44.83. NetGear NTGR fell $3.37, or 16.7%, to $16.76 after the company disappointed investors with its quarterly results.[28] The Securities and Exchange Commission said it would distribute more than $30 million to about 250,000 investors in a boutique mutual-fund firm charged with allowing excess trading. The funds stem largely from a settlement the SEC reached in 2004 with RS Investments, a mutual-fund firm based in San Francisco, and two of its executives, G. Randall Hecht and Steven M. Cohen.[3]
The shares were trading at $13.89, up $3.25, or 30.55 percent, at 9:51 a.m.[5] On a per-share basis, the company reported adjusted profit of $1.12 a share, compared to $1.08 a share in the year-ago quarter.[29] Motley Fool Rule Breakers is always on the hunt for hot drug stocks and other cutting-edge picks. Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article.[10]
Yee raised the stock's price target to $19 from $10 keeping an "outperform" rating, and said mid-stage trial data for oral Relistor would be the next biggest catalyst for the stock.[14]
All times are ET. : Time reflects local markets trading time. - Intraday data delayed 15 minutes for Nasdaq, and 20 minutes for other exchanges. Disclaimer[18] Stock quotes are delayed at least 15 minutes for Nasdaq, at least 20 minutes for NYSE/AMEX. U.S. indexes are delayed at least 15 minutes with the exception of Nasdaq, Dow Jones Industrial Average and S&P; 500 which are 2 minutes delayed.[11]
• Immersion Corp. (Nasdaq: IMMR ), up 29% after the San Jose, Calif. -based provider of touch technologies named a new CEO. • Horizon Lines, Inc. (NYSE: HRZ ), down 23.1% after the shipping and logistics company cut its 2008 forecast due to weakness in Puerto Rico.[11] The nearest-term competitor, Entereg, from Adolor (Nasdaq: ADLR ) and GlaxoSmithKline (NYSE: GSK ), has enough long-term safety issues to keep it from being approved as a treatment for OIC.[31]
Relistor should be approved in a few months and then Wyeth can begin working out pricing with insurance and health-care agencies in the various EU countries.[31] Relistor is already approved in Canada, and is expected to be approved for opioid-induced constipation (OIC) in Europe by mid-year.[14]
Relistor is an injection designed to treat constipation caused by the use of opiate-based pain medications.[7] Relistor use should be discontinued (with health care professional consultation) if the patient experiences severe diarrhea, vomiting, nausea or abdominal pain.[20] 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.[19]
Progenics is also studying the oral formulation of the drug in a mid-stage trial for OIC in chronic pain patients. [14] Last month, Progenics announced the failure of a late-stage trial of an IV form of the drug for post-op patients.[35]
Progenics is partnered with Wyeth (WYE.N: Quote, Profile, Research ) for the development of the drug.[14] Fortunately, Wyeth seems to be managing quite well. Sales of former blockbuster drug Protonix plummeted 66%, but Wyeth still managed to increase its revenue by 6% year over year.[10] Quarterly sales were $270.5 million, compared to $411.1 million in the year ago quarter.[36] Net Interest Income Before Provision for the first quarter was $21.98 million, up from $21.02 million in the previous year quarter.[36] Assets at the close of the first quarter were $999.2 million, down 1.7 percent from the previous quarter and 0.8 percent from the first quarter of 2007.[3]
Non-interest income increased $56,000, or 6%, in the first quarter of 2008 over the comparable 2007 quarter.[36]
Net income for the quarter was $11.2 million vs. $14 million a year ago and EPS, excluding items, was 39 cents compared with 44 cents a year ago.[28] Net income fell 55% from a year ago to 2.65 billion Swedish kronor ($442 million), while revenue rose 5% from a year ago to 44.2 billion kronor ($7.38 billion).[28] For the next fiscal year, the company projected revenue ranging from $66.9 billion to $68 billion and EPS of $2.13 to $2.19.[28]
Revenue was just slightly shy of Wall Street views, decreasing 2% to $3.613 billion, from $3.687 billion in the year-ago quarter.[29]
Wyeth has forecast that peak sales for the franchise could eventually top $1 billion annually.[15] Analysts surveyed by Thomson Financial were looking for sales of $6.97 billion.[28]
The revenue growth was spurred on by antidepressant Effexor, which rose 15%, and rheumatoid arthritis drug Enbrel, which jumped 36% to $606 million outside North America. [10] Quarterly non-interest income rose to $7.42 million from $6.63 million in the corresponding quarter a year-ago.[36]
More than 1.5 million people in the U.S. have advanced illnesses that require the strongest pain medications, the company said.[12] The median age of the study participants was 68 years, and 51 percent of the participants were women. In both studies, all patients had advanced late-stage illnesses with a life expectancy of less than 6 months.[19] The powerful drug that the hospice doctor had given Roy Neill helped relieve his shortness of breath. The medicine that eased the symptoms of the chronic obstructive pulmonary disease that is killing him was also causing severe constipation. "It was a stressful time," says Mr. Neill, 67 years old. A hospice doctor caring for Mr. Neill at his home suggested he try an experimental drug, methylnaltrexone, designed to treat the constipation.[37] Back in January the FDA added an additional three months of review time so that it could study the drug's side effects.[24] Participants had had either fewer than three bowel movements in the week before treatment or no bowel movement for more than two days. The FDA said patients who were treated with methylnaltrexone bromide had a significantly higher rate of elimination than those receiving placebo.[34] Prior to treatment with Relistor, participants had either less than three bowel movements in the week prior to treatment or no bowel movement for more than 2 days. Patients who were treated with Relistor had a significantly higher rate of elimination than those receiving placebo.[19] Before Relistor treatment the patients had either no bowel movement for at least two days or less than three bowel movements in the preceding week. It was found that patients receiving Relistor had a substantially higher rate of elimination compared to those on the placebo.[20]
The sponsors, Wyeth Pharmaceuticals Inc., carried out clinical studies which demonstrated the safety and effectiveness of Relistor. [20] 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.[30] 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.[30]
Wyeth said the Committee's approval for Relistor will be forwarded to the European Commission for a final decision, expected by mid-year. [33] Progenics also is seeking approval for Relistor (methylnaltrexone bromide) in Europe and Australia.[9] Tarrytown, N.Y. -based Progenics expects to make Relistor available in the U.S. in early June.[9]
Wyeth and Progenics will likely have the OIC market all to themselves for a while.[31]
The medicine is the first to stop morphine-like drugs from interfering with bowel movements, while allowing the drugs to continue blocking pain. [12] In clinical studies, Relistor significantly decreased the constipating effects of opioids without interfering with pain relief.[25]
Based on revised DCF analysis, we are raising our 12-mo target price to $9.50 from $9." CNET Networks, Inc. (CNET Networks) is an interactive media company that builds brands for people and the things, such as technology, entertainment, business and food. [38] The shares rose 32.5 percent yesterday on news news of the favorable opinion in Europe.[5] TYGACIL has been approved for use in patients with CAP in the Philippines and Thailand.[30]
SOURCES
1. Progenics board OKs buyback of up to $15M shares of stock
2. Progenics, Wyeth constipation drug gets FDA approval
3. Business news in brief | Philadelphia Inquirer | 04/26/2008
4. UPDATE: Wyeth, Progenics say FDA approves Relistor | Latest News | News | Hemscott
5. Progenics, Wyeth get drug approval | Business in the Burbs
6. Progenics Relistor Approved in United States - International Business Times -
7. Progenics Pharmaceuticals (PGNX) NewsBite - Progenics' Drug Gets FDA Approval
8. Premarket Roundup: American Express, Progenics Pharma | Chron.com - Houston Chronicle
9. Therapeutics Daily
10. Wyeth Recovers From Its Heartburn
11. Biggest small-cap gainers and losers in Friday's trading - SmallCapInvestor.com
12. Progenics stock leaps as drug wins approval | lohud.com | The Journal News
13. Progenics shares jump on FDA OK of first drug | lohud.com | The Journal News
14. Progenics shares soar on bowel drug approval | Markets | Hot Stocks | Reuters
15. UPDATE 2-Wyeth, Progenics bowel drug wins US approval | Deals | Regulatory News | Reuters
16. Progenics shares rise on positive opinion | Business in the Burbs
17. Wyeth drug for the dying gets FDA approval | Philadelphia Inquirer | 04/25/2008
18. Ahead of the Bell: Progenics climbs on Relistor approval
19. FDA Approves Relistor for Opioid-Induced Constipation
20. Relistor For Opioid-Induced Constipation Approved By The FDA
21. Relistor Helps Ease Painkiller-Related Constipation - washingtonpost.com
22. Thursdays Health Winners & Losers | Winners & Losers | AZN BMY IMCL IVC PGNX WLP ZMH - TheStreet.com
23. Progenics, Wyeth constipation drug gets FDA approval -- Newsday.com
24. FDA approves Wyeth, Progenics drug - FierceBiotech
25. Prescribing Reference: Drug News - Relistor approved for OIC
26. Wyeth, Progenics get positive opinion from EMEA panel over Relistor - Forbes.com
27. FDAs OK of Relistor Bodes Well for Progenics | Biotech | PGNX WYE - TheStreet.com
28. Fridays Winners & Losers: Progenics | Winners & Losers | ERIC GENZ ISIS MSFT NTGR PGNX THC WYE - TheStreet.com
29. Fridays Health Winners & Losers | Winners & Losers | AMGN CVTX GENZ GILD ISIS PGNX THC - TheStreet.com
30. More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL
31. Progenics' Double Dose of Good News
32. News: Progenics and Wyeth Obtain FDA Nod for Drug to Treat Opioid-Induced Constipation. Genetic Engineering & Biotechnology News - Biotechnology from Bench to Business
33. Wyeth, Progenics Get Positive Opinion For Relistor
34. Medical News: FDA Okays Methylnaltrexone Bromide (Relistor) for Opioid-Induced Constipation - in Product Alert, Prescriptions from MedPage Today
35. Health Blog : Constipation Drug Approved for the Very Ill and the Dying
36. RTTNews - Quick facts Articles, Positive EPS Surprises, News Analysis, Earnings, Audio News.
37. Free Preview - WSJ.com
38. StreetInsider.com
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