Tracleer and PPH News Viagra helps boy with lung disease
10 Jan 2005 - CBC News - HAMPTON, N.B. - A New Brunswick boy is getting help for his lung condition from an unexpected source – Viagra.
Braden Gendron, 6, has pulmonary hypertension, or PH, a rare and usually fatal condition affecting the lungs and heart. The only cure is a lung transplant. Braden takes small doses of Viagra, a drug normally prescribed for erectile dysfunction, to increase blood flow to the lungs and help him breathe. His mother said it was the best option his doctors offered. "They told us we could try him on either Flolan, which is an IV drug. He would have to wear a pack continuously... Or they could try a new drug, which was the Viagra," said Jennifer Gendron. Doctors have been using Viagra as a treatment for PH for several years and have found it can stabilize about half of patients. "What we have seen is that with our small group of patients here in Toronto... some patients actually do quite well over a year, some patients even longer," said Dr. Tilman Humpl, Braden's heart specialist at the Hospital for Sick Children. Braden takes four small doses of Viagra every day. His father Dan cuts each pill in half. But even the small amount of drug is having dramatic results. "In the springtime, he rode his bike. We were really surprised because we didn't think we'd see him do that again," said Jennifer. However, because treatment for PH isn't an approved use of Viagra in Canada, neither drug insurance nor government programs will cover the cost of the drug, about $420 a month. Pfizer, maker of Viagra, says it is talking with drug regulators about approving the drug for other purposes.
France OKs United Therapeutics drug
Chris Baysden
French regulators have approved United Therapeutics Corp.'s high blood pressure treatment Remodulin.
March 8, 2005 - The approval is for the Remodulin Injection, which is used for the subcutaneous - or under the skin - treatment of primary pulmonary hypertension. United Therapeutics Corp. (Nasdaq: UTHR) expects the drug to be approved by other European Union countries in May through the mutual recognition approval process. "It opens the door to all of Europe," Fred Hadeed, United Therapeutics' chief financial officer, says of the approval in France. Two Remodulin delivery methods, intravenous and subcutaneous, have been approved in the U.S. The company plans to try to get approval for intravenous delivery of Remodulin in Europe, but that probably won't happen this year, Hadeed says. Remodulin, in its two delivery methods, has a worldwide sales potential between $300 million to $500 million, according to Hadeed. Pulmonary hypertension is a potentially fatal disease that causes people to have elevated blood pressure in the lungs. Patients have difficulty transferring blood through their lungs, which often causes them to have shortness of breath. The disease is hard to diagnose because the blood pressure in the rest of the body can appear normal, Hadeed says. United Therapeutics estimates that about 50,000 people in Europe have pulmonary hypertension - but only 15 to 20 percent of those have been diagnosed, Hadeed says. Remodulin's competitors include the pulmonary hypertension drug Flolan, which is marketed by GlaxoSmithKline. There is no cure for the disease, and treatments are designed to relieve the symptoms, according to information on a GSK Web site.
The Silver Spring, Md.-based biotechnology company has its research and development operations in Research Triangle Park, where it employs almost 30 people.
Approved for All Forms of Pulmonary Arterial Hypertension
2005/6/9 - Actelion Ltd (SWX:ATLN) (Other OTC:ALIOF) announced today that Tracleer(r) (bosentan) is now available upon prescription to all patients in Japan. In early April, the Japanese Ministry of Health, Labor and Welfare had granted formal approval of Tracleer(r) for the treatment of all forms of Pulmonary Arterial Hypertension PAH (WHO class III and IV). In early June, the same authority has granted full reimbursement status for this orally available dual endothelin receptor antagonist. Tracleer(r) is being made available in Japan through Actelion's own affiliate, with initially 35 territory managers focusing on hospital-based physicians.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion, said: "With today's launch in Japan, Actelion has realized its strategic goal of commercializing Tracleer(r) with its own infrastructure in all key pharmaceutical markets worldwide. We can now further leverage our worldwide capabilities in clinical development, regulatory affairs and marketing and sales with new innovative compounds from our own drug discovery efforts or, should the opportunity arise, from in-licensed or acquired drugs."
Satoshi Tanaka, Dr med Sci, and President of Actelion Japan, commented: "Since Actelion Japan has been founded in October 2001, we have built a fully government-certified affiliate. By having documented our professionalism, the Japanese authorities have gained the necessary confidence not only in Tracleer(r) and its clinical benefits, but also in Actelion's capabilities to responsibly promote Tracleer(r) in Japan. We are ready to ensure that Japanese physicians and patients are receiving the same level of service and support as Actelion has successfully established already in North America and Europe."
Dr. Tanaka concluded: "By having conducted a local clinical trial -- bridging to the results of the international Phase 3 clinical trials -- we have generated initial clinical development and regulatory expertise to support the global clinical development of future Actelion compounds."
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% 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, 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 (SWX:ATLN).
From: Health Help News
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