Tracleer and PPH News
FDA Clears Way for New PH Drug
by John C. Martin
06-09-05 - People with pulmonary hypertension now have a new treatment option at their disposal. The U.S. Food and Drug Administration has approved the drug Revatio, known by its generic name sildenafil citrate, for pulmonary arterial hypertension, says its manufacturer, Pfizer.
Sildenafil citrate is actually the active ingredient in Viagra—Pfizer's medication that it says is used by 26 million men around the world for erectile dysfunction.
Clinical Development History
"Pfizer undertook a 6-year clinical development program in pulmonary arterial hypertension because patients with this devastating disease needed more medical options, and there was evidence that sildenafil could be an effective treatment," said Joe Feczko, MD, President of Worldwide Development and Vice-President of Global Research and Development at Pfizer, in a statement.
The FDA had granted the medication priority review status, an expedited review process for investigational medications that may address unmet medical needs. According to Pfizer, the government agency's approval hinged on a pivotal randomized, double-blind, controlled clinical study involving 277 patients with pulmonary arterial hypertension. Patients were assigned at random to one of three doses of Revatio three times daily or doses of placebo for the same frequency. Researchers then measured the exercise capability of each patient after 12 weeks of therapy.
Drug Demonstrates Efficacy
At the end of the study, those receiving the doses of Revatio showed highly significant improvements in the distance they were able to walk in 6 minutes compared to those consuming a placebo, Pfizer stated. They also showed improvements in their pulmonary artery blood pressure and other measures of heart function in the study. A 1-year placebo-controlled extension trial was also conducted. At its conclusion, the researchers reported that exercise capacity and walking distance were stable in each of the patients who took part, and 94 percent were still alive.
Since no differences in effectiveness were seen between the three dosage groups in the original trial, the drug will be prescribed at the minimum dose used in the trial—20 mg three times per day, Pfizer reported.
A First
The company says its medication will be the first oral therapy for people with early stages of pulmonary hypertension. It is indicated for the treatment of PH to improve exercise ability. Pfizer says the drug has yet to be evaluated in patients currently taking Tracleer (bosentan), manufactured by Actelion Pharmaceuticals as an oral therapy to improve exercise ability in later-stage pulmonary arterial hypertension.1 However, a preliminary European study examining the effectiveness of Revatio and Tracleer reported that the combination may be safe and effective for people with the illness.2
In studies on Revatio, the most common side effects reported were headache, indigestion, flushing, nosebleed, and insomnia, Pfizer stated.
The company says it expects to make the drug available to patients by mid-July.
1. PH Neighborhood. Tracleer: Endothelin Receptor Antagonist. Available at: http://www.phneighborhood.com/content/treatment_options/
medications_for_ph_1643.aspx. Accessed June 9, 2005.
2. Hoeper MM, Faulenbach C, Golpon H, Winkler J, Welte T, Niedermeyer J. Combination therapy with bosentan and sildenafil idiopathic pulmonary arterial hypertension. Eur Respir J 2004 Dec;24(6):1007-10.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
North Carolina, Maryland vie for drug-making plant
(News & Observer, The (Raleigh, NC) (KRT) Via Thomson Dialog NewsEdge) Mar. 24--North Carolina is competing with Maryland to land a drug manufacturing plant that would bring at least 150 jobs. To lure the $54 million project to Research Triangle Park, state and local officials are working on an incentive package.
United Therapeutics wants to build the plant to make a drug for pulmonary arterial hypertension, a cardiovascular disease that leads to heart failure if left untreated.
Two possible locations are under consideration, said David
Zaccardelli, a senior executive in charge of United Therapeutics' pharmaceutical research and development. The plant could be built on land the company already owns next to its headquarters in Silver Spring, Md., or on 50 acres in Research Triangle Park.
"It's contingent upon economic incentives," Zaccardelli said.
Durham County Commissioners are expected to vote Monday on whether to offer the company a $650,000 incentives package. The cash could be used for site preparation, utility extensions and employee training.
But United Therapeutics is also discussing incentives with economic developers in Maryland, Zaccardelli said.
North Carolina could sweeten the offer to tip the scale in RTP's favor -- especially since United Therapeutics is promising to create the kind of jobs that Gov. Mike Easley has identified vital for the state's economy.
State incentives usually include job creation grants. Members of the state's economic investment committee determine the amount of the grants based on the type of job and how much they pay, said Greg Thomas, a spokesman of the N.C. Department of Commerce. Grants tend to be higher if the jobs are knowledge-based and pay well. "They look for high impact projects," Thomas said.
Biotech and pharmaceutical companies are considered high-impact, as are projects involving manufacturing and research and development, Thomas said. But he declined to talk about any particular project.
United Therapeutics was founded in 1996 in the Triangle with a drug licensed from Glaxo Wellcome. Shortly after, the headquarters was established in Maryland, where CEO Martine Rothblatt lives.
The company still leases space in RTP, where it employs 25. That operation oversees the testing of cardiovascular and infectious disease treatments and works with regulators to get new drugs approved for sale.
One of the experimental drugs in the development pipeline is a pill version of Remodulin, an injectable treatment for pulmonary arterial hypertension that United Therapeutics brought to market in 2002. Oral Remodulin is in final testing and is expected to become available as early as 2008.
The company plans to make the pill at the 125,000-square-foot-plant it is considering building in RTP or Silver Spring.
Having the scientists who oversaw the development nearby would help with manufacturing the pill, said Zaccardelli, who works out of the RTP office.
The Triangle also has the kind of trained labor pool that's needed to staff such a plant. "It would be nice to expand here," he said.
Similar arguments convinced U.S. pharmaceutical giant Merck to build a $300 million vaccine manufacturing plant north of Durham, and Japanese drug maker Eisai to expand its RTP operations and build a $105 million plant to produce cancer drugs.
If RTP gets the United Therapeutics plant, it is also likely to get an expansion that is already being planned, Zaccardelli said. The expansion would double the size of the plant to make the injectable version of Remodulin.
Ted Conner, vice president of economic development for the Greater Durham Chamber of Commerce, would just like to see United Therapeutics plant roots in the Triangle.
It's easy to move out of leased space, but "if you own a building, you're a lot more permanent," Conner said.
Two fen-phen lawyers appeal judge's revocation of bond
Cincinnati Post - OH,USA
... lawyers were already determined in a civil case to have defrauded more than 400 clients in a $200 million settlement involving the diet drug fen-phen. ...
Fen-phen lawyers are jailed
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The fen-phen victims should have gotten $133 million, with the lawyers entitled to the remainder. Instead, the victims got $45.5 million, according to court ...
Judge sends 3 fen-phen lawyers off to jail
Kentucky.com - Lexington,KY,USA
Angela Ford, who represents more than 400 former fen-phen clients in the civil lawsuit, said Bertelsman's decision reflects the outrage that many lawyers in ...
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