Tracleer and PPH News A Drug to Get Your Blood Pumping
By Charly Travers (TMF BreakerCharly)
February 18, 2005 - There are very few sure things in biotech. Investing in the sector involves making a lot of educated guesses and weighing the rewards for being right against the consequences for being wrong. One company that has a drug I feel pretty good about is Encysive Pharmaceuticals (Nasdaq: ENCY). Encysive recently released phase 3 clinical trial data on its drug Thelin for treating pulmonary arterial hypertension (PAH), or high blood pressure in the lungs. PAH is a big problem because the heart has to work harder than normal to move blood through the lungs. This causes fatigue, chest pain, and eventually heart failure. PAH is chronic and incurable without a heart and lung transplant. Drugs for PAH can improve the patient's capacity for physical activity and also increase the length of time before symptoms worsen. One approved drug is Tracleer, from Swiss company Actelion. Tracleer has been commercially successful, with sales of several hundred million dollars a year. While Actelion's Tracleer is the first mover, Encysive's Thelin is poised to capture a big chunk of this market. The recently released clinical trial data showed that Thelin works just as well as Tracleer and appears to be safer. Thelin also needs to be taken only once a day instead of twice, like Tracleer. Encysive is going to file a new drug application with the Food and Drug Administration in May and seek a priority review. If it gets a priority review, Thelin could be on the market by the end of the year. If there's a standard review, the drug could launch during the first half of next year. Given that Thelin, at the very least, looks to compare favorably to Tracleer, I expect that the drug will reach several hundred million dollars in sales. Seeing as Encysive has a current market cap of $670 million, this is a situation that looks pretty good to me. For additional articles on the biotech industry, see:
Searching for Cheap Biotechs
Investing in a Cure
Grading Old-School Biotech
Biotech Class of 2004
Fool contributor Charly Travers is the biotech analyst for Motley Fool Rule Breakers. He does not own shares of any company mentioned in this article.
Actelion Drug Tracleer Gets High Japan Price
June 08, 2005
Dow Jones Newswires
0716 GMT [Dow Jones] Actelion's (ATLN.EB) Tracleer will be sold at $60,000 in Japan, which is a much higher price than expected, says Kepler Equities analyst Denise Anderson. Drug sells at around $35,000 in the US, and European price is similar to US price, she adds. Rates shares buy with CHF180 target. Closed at CHF125.30. (AAG)
Source: Actelion Ltd
Actelion Launches Tracleer in PAH in Japan
Approved for All Forms of Pulmonary Arterial Hypertension -- Full Reimbursement Status Granted
ALLSCHWIL, Switzerland, June 8, 2005 (PRIMEZONE) -- 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).
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A on Wednesday, 8 June 2005, 12.00 CET / 06.00 a.m. EST / 11.00 BST / 19.00 JST
Dial: +41 (0)91 610 56 00 (Europe)
+1 (1) 866 291 4166 (U.S.)
+44 207 107 06 11 (U.K.)
00531 121 266 (Japan)
Webcast -- Live and replay on demand
Actelion webcasts its Investor Conference Call. On the Web, you may either follow the call live or have the call replayed later on demand. To access the webcast live, simply visit the link on our homepage http://www.actelion.com/ 5-10 minutes before the conference is due to start.
Approximately 60 minutes after the call has ended, the archived investor webcast will be available for replay on the website "Investors/Past Events".
CONTACTS: Actelion Ltd
Gewerbestrasse 16
CH-4123 Allschwil
http://www.actelion.com
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
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