Tracleer and PPH News Wyeth Backs Changes to Diet Drug Settlement
NEW YORK (Reuters) - Jan 10, 2005 - Wyeth on Monday said it will support proposed changes to a national settlement with former users of its "fen-phen" diet drugs, allowing quicker settlements for claims related to some of the less serious side effects from the recalled appetite suppressants.
Wyeth said it is endorsing the proposed changes after their approval by an overwhelming majority of former users of its two drugs, Pondimin and Redux. The drugs were recalled in 1997 after being linked to heart valve damage and a highly fatal lung condition. Madison, New Jersey-based Wyeth reached a national settlement in 1999 under which past U.S. users of the drugs were entitled to differing levels of compensation -- depending largely on the seriousness of their health problems. The changes would create a new claims processing structure, funding arrangement and payment schedule for the least serious, but most numerous, claims. The changes must be approved by federal Judge Harvey Bartle. Wyeth has set aside nearly $17 billion to cover its costs from the settlement and other fen-phen legal liabilities, and has warned it may need to take additional charges. The company reached an agreement last July with lawyers for former users of the recalled diet drugs on the proposed changes in the settlement. At the time, Wyeth said the changes would affect about 40,000 people, the lion's share of remaining claimants within the national settlement, and help stem the number of medical claims being submitted that Wyeth believes to be fraudulent. Under the proposed changes, Wyeth on Monday said it would set aside $1.28 billion to pay claimants who pass a medical review determining they suffered damage from the drugs, which were part of the popular fen-phen diet cocktail. Anyone who participates in the new part of the settlement has heart valve surgery or other more serious medical conditions by Dec. 31, 2011, would remain eligible to submit claims to the existing settlement trust. Former fen-phen users within the settlement who have more-serious medical claims will not be affected by the proposed changes, Wyeth said. Many fen-phen users opted out of the national settlement. Wyeth in October said 60,000 people were pressing ahead with U.S. lawsuits alleging medical harm from the drugs. It said cases involving only 350 of the plaintiffs were slated to go to court in the coming year. Shares of Wyeth fell 7 cents to $42.03 in afternoon trading on the New York Stock Exchange. (Additional reporting by Toni Clarke)
Cardiopulmonary Support and Physiology Combined administration of nitric oxide gas and iloprost during cardiopulmonary bypass reduces platelet dysfunction: A pilot clinical study Ada Chung, PhDa,*, Stephen M. Wildhirt, MD, PhDb,*, Shoa Wang, MDa, Arvind Koshal, MDa, Marek W. Radomski, MD, PhD, DScc,*
a Departments of Pharmacology and Cardiothoracic Surgery, University of Alberta, Edmonton, Alberta, Canada
b Department of Cardiothoracic Surgery, German Heart Center Munich, Technical University of Munich, Munich, Germany
c Department of Integrative Biology and Pharmacology and Institute of Molecular Medicine for the Prevention of Human Diseases, University of Texas, Houston, Tex Received for publication December 8, 2003; revisions received June 2, 2004; accepted for publication June 22, 2004. * Address for reprints: Marek W. Radomski, MD, PhD, DSc, Center for Vascular Biology, Institute of Molecular Medicine, University of Texas-Houston, 6770 Bertner Ave, Suite C950J, Houston, TX 77030 (E-mail: Marek.Radomski@uth.tmc.edu). BACKGROUND: Thrombocytopenia and platelet dysfunction are major mechanisms of cardiopulmonary bypass-induced postoperative hemorrhage. This study evaluated the effects of low amounts of nitric oxide, iloprost (prostacyclin analog), and their combination administered directly into the oxygenator on platelet function, platelet-leukocyte interactions, and postoperative blood loss in patients undergoing coronary artery bypass grafting. METHODS: Blood samples from 41 patients randomized to the control, nitric oxide (20 ppm), iloprost (2 ng · kg–1 · min–1), or nitric oxide plus iloprost groups were collected during cardiopulmonary bypass. Platelets and leukocytes were enumerated. Platelet membrane glycoprotein Ib and glycoprotein IIb/IIIa, P-selectin, platelet-derived microparticles, leukocyte CD11b/CD18 (Mac-1), and platelet-leukocyte aggregate were quantified by means of flow cytometry. Collagen and thrombin receptor-activating peptide-induced platelet aggregation in whole blood was analyzed by means of aggregometry. RESULTS: Both nitric oxide or iloprost attenuated cardiopulmonary bypass-induced thrombocytopenia, reduction of glycoprotein Ib and glycoprotein IIb levels, translocation of P-selectin, microparticle formation, Mac-1 upregulation, and suppression of collagen-induced aggregation. Nitric oxide plus iloprost was significantly more effective in preventing thrombocytopenia, microparticle formation, and P-selectin translocation. Moreover, this treatment preserved thrombin receptor-activating peptide-induced aggregation, which was not rescued by single treatments. Both nitric oxide and nitric oxide plus iloprost attenuated postoperative blood loss.
CONCLUSIONS: Nitric oxide plus iloprost reduced the deleterious effects of cardiopulmonary bypass, such as thrombocytopenia, platelet activation, platelet-leukocyte aggregate formation, and suppression of platelet aggregative responses. The reduced postoperative bleeding observed with this treatment suggests that this is a new and clinically feasible therapeutic option for patients subjected to cardiopulmonary bypass.
United Therapeutics foresees solid growth
Competition looms for Silver Spring drugmaker
by Steve Berberich, Staff Writer
Dec. 9, 2005 - Revenues at pharmaceutical company United Therapeutics Inc. of Silver Spring jumped 65 percent and net income leapt 152 percent for the third quarter of 2005, compared with same quarter in 2004.
United Therapeutics Inc. of Silver Spring, headed for the best financial performance in its 10-year history, has new versions of its flagship drug in the pipeline, but one analyst says the company’s success may level off at least for a while as the competition stiffens.
Following a full year of expanded sales of its lead product, Remodulin, revenues jumped 65 percent and net income leapt 152 percent for the third quarter of 2005, compared with same quarter in 2004.
Remodulin treats pulmonary arterial hypertension, a life-threatening disease affecting about 50,000 people in North America and Europe.
United Therapeutic shares closed late Wednesday above $71, after beginning the year at $43. Shares sold for $20 in January 2004.
But Navdeep Jaikaria, senior analyst with Rodman and Renshaw in New York, said competing treatments from other companies are now entering the market and may soon limit United Therapeutics’ recent surge in profits, after ‘‘certainly a good quarter,” he said.
CFO Fred Hadeed expects the recent success to continue, however.
‘‘Last year, the day before Thanksgiving, we received approval of FDA for use of Remodulin intravenously. And sales began on this use immediately,” Hadeed said.
In 2002, the U.S. Food and Drug Administration had approved use of Remodulin through subcutaneous injections, just under the skin. ‘‘Now, it is fair to say that Remodulin gets more use for both routes, intravenously and subcutaneously,” Hadeed said.
CEO Martine Rothblatt founded the company in 1996, largely on the hope of finding relief for her daughter’s breathing difficulties from the disease. That same year, the company licensed rights to develop Remodulin from its inventors at Glaxo Welcome and Pfizer.
There is no known cure for the disease, but Remodulin is widely used to relieve the symptoms.
This year, United Therapeutics secured approvals for use of Remodulin in 22 more countries, said Hadeed, bringing its total to nearly 30 nations, including most of the European Union, most of North America, Australia, Switzerland and Argentina.
Rodman and Renshaw recently downgraded its recommendation for United Therapeutics’ stock from ‘‘buy” to ‘‘neutral.”
‘‘We are concerned about intravenous use of Remodulin because there are many drugs now on the market now,” said Jaikaria, who has tracked the company for several years. He said physicians are telling him that an inhaled treatment for pulmonary arterial hypertension called Ventavis, made by CoTherix Inc. of San Francisco, ‘‘is doing quite well now.”
CoTherix reported sales of $8.4 million for Ventavis in the quarter ended Sept. 30, double the previous quarter’s sales. Overall, the company lost $6.2 million for the quarter.
Before United Therapeutics began marketing Remodulin, the treatment market was dominated by the drug Flolan, sold by the large British pharmaceutical firm GlaxoSmithKline. Both drugs are forms of prostacyclin, which helps relax blood vessels in the lungs.
‘‘In terms of convenience and safety alone we are now beating Flolan,” Hadeed said.
Remodulin is a synthetic form of prostacyclin that is stable in the blood for more than four hours, while Flolan is a natural formulation that is stable for only two minutes. Flolan must be administered continually, directly into an artery, through a catheter, and requires refrigeration.
Remodulin is delivered in a similar way, but does not need to be refrigerated. Also, Flolan is in a powder form that patients need to mix every day before use, while Remodulin is already mixed.
The inhaled Ventavis is also a synthetic form of prostacyclin. CoTherix’s Web site claims that it is ‘‘currently the only prostacyclin treatment that dilates the pulmonary vessels by inhalation.”
Unfazed by the emergence of Ventavis, Hadeed said an inhaled form of Remodulin is on its way to market.
‘‘We have commenced our first trial at 14 hospitals in the U.S. and Europe to enroll 150 patients in phase 2 and 3 trials,” he said, adding that ‘‘much of the safety testing is done.” The inhalant Remodulin has the same active ingredient as the injected form.
Aiming for still more patient convenience, United Therapeutics is also developing a pill form of Remodulin.
Jaikaria said an inhalable Remodulin would be positive for the company, and that for the next two years, while the new product is developed and marketed, stockholders should not sell.
Jennifer M. Chao, senior analyst for biotechnology at the Deutsche Bank, North American Equity Research in New York, anticipates United Therapeutics’ stock to rise following a presentation of a study of inhaled Remodulin by an independent firm at the American Heart Association Meeting last month in Dallas. The product is ‘‘is on track for potential top-line results in the second quarter ’06 timeframe,” Chao said.
United Therapeutics’ revenues grew to $33.0 million in the third quarter of 2005, compared with $20.0 million in the third quarter of 2004. Gross margins from sales were $29.6 million in the third quarter of 2005, up from $17.8 million a year ago
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