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Actelion Ltd.: JACC Publication on Tracleer in Children with PAH
Retrospective Analysis Highlights Efficacy Data on Long-Term Use
ALLSCHWIL, Switzerland, Aug. 16, 2005 (PRIMEZONE) -- Actelion Ltd. (Other OTC:ALIOF) (SWX:ATLN) announced today that the Journal of the American College of Cardiology (JACC) has published a new study that investigated the long-term outcome of children with pulmonary arterial hypertension (PAH) treated with the dual endothelin receptor antagonist Tracleer(r) (bosentan) with or without concomitant prostanoid therapy.
Commenting on the publication, lead investigator Dr. Erika Berman Rosenzweig, New York Presbyterian Hospital, New York, USA, said: "In the present study, clinical experience from two PAH centers involving 86 paediatric patients with PAH who received bosentan therapy was pooled to retrospectively assess the safety and long-term effects of bosentan treatment on functional capacity, hemodynamics and survival in children with PAH. The concomitant administration of bosentan and prostanoid therapy was also evaluated."
The authors conclude that in this study bosentan, with or without concomitant prostanoid therapy, was shown to be efficacious for the treatment of PAH in children. In addition, this study also indicated that the safety profile appears similar to that in adult PAH patients.
Dr. Rosenzweig added: "Considering the limited clinical paediatric data currently available, the present retrospective study, which involves a large cohort of children with PAH, provides a fairly extensive experience of long-term safety and efficacy of bosentan for the treatment of paediatric PAH."
Details on study publication and results:
The study, "Effects Of Long-Term Bosentan in Children with Pulmonary Hypertension," by E.B. Rosenzweig, is published in the August issue of JACC (Rosenzweig E.B. et al. Volume 46 Issue 4 Pages 697-704).
In this retrospective study, 86 children with PAH (either idiopathic, associated with congenital heart disease or connective tissue disease) started bosentan with or without concomitant intravenous epoprostenol or subcutaneous treprostinil therapy. Median exposure to bosentan was 14 months. In 90 percent of patients, World Health Organisation (WHO) functional class was improved (46 percent) or unchanged (44 percent). The one- and two-year Kaplan-Meier survival estimates were 98 percent and 91 percent, respectively. At cut-off date, 68 patients (79 percent) were still treated with bosentan, 13 (15 percent) were discontinued and 5 (6 percent) had died.
New bosentan formulation for children under clinical evaluation:
Considerable data exists showing that bosentan improves hemodynamics and exercise capacity in adults with PAH, but so far there has been limited data available on its long-term effects in children.
In the past three years, Actelion worked on a children-specific formulation of bosentan that recently entered clinical evaluation.
About Tracleer(r) in Pulmonary Arterial Hypertension (PAH)
Tracleer(r), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) and made available by Actelion subsidiaries in the United States, the European Union, Japan, Australia, Canada, Switzerland and other markets worldwide.
In clinical trials leading to the marketing approval of the drug, approximately 11 percent of PAH patients receiving Tracleer(r) experienced abnormal but reversible liver enzyme elevations. It is therefore important that patients undergo monthly liver monitoring. Due to the risk of birth defects, women who are pregnant, or of childbearing age who do not use a reliable method of contraception, must not take Tracleer(r).
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The function of the heart and lungs is severely compromised, manifested by a limited exercise capacity, and, ultimately, a reduced life expectancy. Approximately 100,000 people in Europe and the United States are afflicted with either primary or secondary forms of the disease related to conditions or tissue disorders that affect the lungs, such as scleroderma, lupus, HIV/AIDS or congenital heart disease.
Actelion Ltd.
Actelion Ltd. is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug, Tracleer(r), an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer(r) through its own subsidiaries in key markets worldwide, including the United States (based in south San Francisco), the European Union, and Japan, as well as Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium -- the single layer of cells separating every blood vessel from the blood stream. Actelion focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN).
For further information please contact:
Actelion Ltd.
Gewerbestrasse 16
CH-4123 Allschwil
CONTACT:
Investor Contact:
Roland Haefeli
+41 61 565 64 58
+1 650 624 6936
Media Contact:
Peter Engel
+41 61 565 66 28
+1 650 624 6996
Product Information:
Alan Archer
+41 79 289 80 83
Ex-clients want lawyers to put $64 million in receivership
Division of fen-phen settlement at issue
By Andrew Wolfson
awolfson@courier-journal.com
The Courier-Journal
The former lawyers for plaintiffs injured by the diet drug fen-phen misappropriated $64.4 million from their clients and should be forced to give that amount to a receiver while a judge determines how much the clients should get back, says an attorney who now represents the clients.
"The court should appoint a receiver to ensure that the attorney defendants cannot defeat justice in this case by further squandering plaintiffs' settlement proceeds," Lexington lawyer Angela Ford says in a motion filed in Boone Circuit Court.
Special Judge William Wehr is expected to take up the motion this morning as he continues to grapple with the legal scandal stemming from the $200 million settlement of Kentucky's fen-phen case in 2001.
Wehr already has held that three Lexington lawyers, William Gallion, Shirley Cunningham Jr. and Melbourne Mills Jr., who paid themselves fees of more than $20 million each, deliberately deceived their clients, violating their fiduciary duty by "passing out money to themselves and others like it was theirs to do with as they wish."
Wehr today is scheduled to consider how much the lawyers should be forced to repay.
Their attorney, William Johnson, declined to comment on Ford's motion for a receiver, saying he didn't get it until yesterday. He has asked Wehr to set aside his finding that the lawyers breached their duties.
The plaintiffs also have asked the court to find that Cincinnati lawyer Stan Chesley, a nationally known class-action expert who was hired by the Lexington lawyers to negotiate the settlement, violated his fiduciary duty to the clients as well.
Chesley, who also collected a $20 million fee, contends his role in the case was limited and that he had no contact with clients or duty to them.
The case has prompted the forced resignation of the judge who presided, Joseph Bamberger, who was publicly reprimanded in February by the state Judicial Conduct Commission.
The commission said Bamberger "shocked the conscience" by approving fees of $106 million for lawyers and consultants -- including a close friend -- while the plaintiffs collected a total of only about $74 million.
Bamberger also allowed another $20 million to be funneled into a charitable fund, then became one of its $60,000-a-year directors, along with the Lexington lawyers.
After details of those transactions began to leak out, Ford signed up former plaintiffs who then sued their ex-lawyers, including Chesley. She now represents 421 of the 440 original plaintiffs, according to court papers filed last week.
The plaintiffs and lawyers are barred from commenting on the case because of a gag ordered issued earlier at the request of the Lexington attorneys; Ford is seeking to have it set aside.
Ford contends that under their contingency contracts, which called for Gallion, Cunningham and Mills to be paid no more than 33 percent of the settlement, they should have collected a total of $46 million but instead paid themselves $66.3 million.
Ford says Chesley should have been paid $13 million but instead collected $20.5 million. Chesley didn't return a call yesterday; his lawyer, Frank Benton IV, declined to comment, citing the gag order.
In all, 52 percent of the settlement, or $106.3 million, went to various lawyers and other professionals, according to Ford's calculations.
In a March 8 order, Wehr said "simple arithmetic" showed that the Lexington lawyers paid themselves fees far in excess of what was allowed in their contracts. Wehr also froze the money in the Fund for Healthy Living, saying the lawyers never told their clients the magnitude of the leftover funds.
The Lexington attorneys asked Wehr to vacate that order, repeating their already rejected assertion that they had to set aside money in the settlement to cover future claims from fen-phen users, insurers or other health-care providers.
When no such claims were made, "additional attorney's fees were allowed by the court, and the balance was distributed to a charitable trust," Johnson, the defendants' lawyer, said in a motion.
"The position long advocated by defendants Mills, Gallion and Cunningham is … the settling claimants … received full value for their claims," he said. "If plaintiffs received all they were entitled to, then the disposition of any surplus is of no importance to them because the surplus was never theirs."
Fen-phen became the diet craze of the 1990s when researchers found that when mixed together, two appetite suppressants, fenfluramine and phentermine, caused weight loss. But in the fall of 1997, the U.S. Food and Drug Administration removed fen-phen from the market after it was shown to cause heart defects.
The next year, five Kentucky plaintiffs filed suit in Boone Circuit Court against American Home Products Corp., which made one of the drugs in fen-phen. Eventually 440 Kentuckians, opting out of a national case, joined in the Boone County suit.
Reporter Andrew Wolfson can be reached at (502) 582-7189.
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