Tracleer and PPH News
Actelion reports further progress to additional markets for Tracleer in Pulmonary Arterial Hypertension
Reimbursement status achieved in Australia - Labeling questions received from Japanese regulator - Limited commercial launch on a named-patient basis in Taiwan
ALLSCHWIL/BASEL, SWITZERLAND - 15 December 2003 - Actelion Ltd (SWX: ATLN) has announced today that its lead product, Tracleer® in pulmonary arterial hypertension, has made further progress to market in Australia, Japan and Taiwan. This dual endothelin receptor antagonist is already commercialized successfully in the United States, the European Union, Canada and Switzerland as well as Israel.
In Australia, the committee in charge of reviewing the health economic justification for new medicines (PBAC) has recommended that the Australian Federal Government list and reimburse Tracleer® on the national Pharmaceuticals Benefits Scheme (PBS), as a cost effective therapy for adults and children older than 3 years of age suffering from either primary pulmonary hypertension (PPH) or from PAH associated with systemic scleroderma (WHO Class III/IV).
Once the decision has been made operational in practice by the Australian Federal Health Department in the coming months, Actelion will immediately make Tracleer® available on a commercial basis. In the meantime, Actelion will continue its compassionate use program that has already significantly benefited more than 150 Australian PAH patients.
In Japan, the regulatory authority has asked Actelion to provide additional information related to the potential labeling, product specification and testing methods as well as the related pharmacovigilance system. These questions follow the legally prescribed six-month review process that was applied for the first time in Japan for designated orphan drugs, such as Tracleer®. Actelion has immediately started to provide the required information to the authorities in charge and looks forward to concluding the regulatory process in Japan in the coming months.
In Taiwan, Tracleer® was granted orphan drug status in the fall of 2003. As a consequence, Actelion's Taiwanese distribution partner, Excelsior Biopharmaceutical Ltd., has now been authorized to immediately commence the commercial launch of Tracleer® on a named-patient basis, pending full national regulatory approval and reimbursement decisions.
About Tracleer® in pulmonary arterial hypertension
Tracleer®, the first oral dual endothelin receptor antagonist, has demonstrated its efficacy in two pivotal, placebo-controlled studies. Tracleer® has shown statistically significant improvements in the primary efficacy endpoint of exercise capacity with patients achieving a significantly greater, and clinically meaningful increase in walking distance compared to placebo.
Clinical trials have also demonstrated Tracleer®'s efficacy in significantly decreasing dyspnea (shortness of breath), one of the most debilitating symptoms for people with PAH. Additionally, treatment with Tracleer® is also associated with a significant delay in disease progression (the time to clinical worsening). Clinical worsening is defined as combined endpoint of death, hospitalization or discontinuation due to worsening PAH, or initiation of epoprostenol therapy.
In clinical trials, approximately 11 % of PAH patients receiving Tracleer® 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 woman of childbearing age, who do not use a reliable method of contraception, must not take Tracleer®.
About Pulmonary Arterial Hypertension
Around 100,000 people in Europe and the US currently suffer from pulmonary arterial hypertension, which includes PPH or PAH related to other diseases such as scleroderma, a degenerative connective tissue disease. Early diagnosis is important for PAH patients. Unfortunately, diagnosis can often be delayed because initial symptoms are unspecific (i.e. breathlessness) and therefore go undetected or are attributed to other diseases.
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Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarter in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union as well as Canada 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
Investor Contact
Roland Haefeli
+41 61 487 34 58
+1 650 624-6936
Media Contact
Peter Engel
+41 61 487 36 28
http:// www.actelion.com
UPDATE 1-Actelion says Tracleer aids Eisenmenger's patients
ZURICH, July 12 (Reuters) - Actelion's (ATLN.S: Quote, Profile, Research) flagship Tracleer drug decreases pulmonary vascular resistance in patients with Eisenmenger's syndrome who cannot be treated in other ways, the Swiss biotech company said on Tuesday.
The drug also improved the patients' capacity to exercise, Actelion's Breathe-5 study showed.
Eisenmenger's syndrome is a progressive heart condition in people who have a congenital heart defect or hole in the heart.
Eisenmenger's patients develop a severe form of pulmonary arterial hypertension as a complication of their congenital heart defect, which cannot be treated by convential means, including surgery, Actelion said in a statement.
A typical symptom of the disease is a blue tinge to the skin resulting from low blood oxygen concentration.
Fifty-four patients participated in the study.
Tracleer, also known by its chemical name bosentan, accounts for virtually all of the company's revenue and has rivals in Pfizer Inc.'s (PFE.N: Quote, Profile, Research) Revatio and in Thelin, a drug being developed by U.S. company Encysive Pharmaceuticals Inc. (ENCY.O: Quote, Profile, Research).
Tracleer was first launched in 2001 in the United States and is available in more than 35 countries. It is also being tested for treatment of forms of pulmonary fibrosis, skin cancer and finger ulcers.
What Is Pulmonary Arterial Hypertension?
Pulmonary (PULL-mun-ary) arterial hypertension (PAH) is continuous high blood pressure in the pulmonary artery. The average blood pressure in a normal pulmonary artery is about 14 mmHg when the person is resting. In PAH, the average is usually greater than 25 mmHg.
PAH is a serious condition for which there are treatments but no cure. Treatment benefits many patients.
The pulmonary arteries are the blood vessels that carry oxygen-poor blood from the right ventricle (VEN-trih-kul) in the heart to the small arteries in the lungs. In PAH, three types of changes may occur in the pulmonary arteries:
The muscles within the walls of the arteries may tighten up. This makes the inside of the arteries narrower.
The walls of the pulmonary arteries may thicken as the amount of muscle increases in some arteries. Scar tissue may form in the walls of arteries. As the walls thicken and scar, the arteries become increasingly narrow.
Tiny blood clots may form within the smaller arteries, causing blockages.
There is less room for the blood to flow through these narrower arteries. The arteries may also stiffen. Over time, some of the arteries may become completely blocked.
The narrowing of the pulmonary arteries causes the right side of heart to work harder to pump blood through the lungs. Over time, the heart muscle weakens and loses its ability to pump enough blood for the body's needs. This is called right heart failure. Heart failure is the most common cause of death in people with PAH.
There are two types of PAH:
Primary pulmonary arterial hypertension (PPAH) is inherited or occurs for no known reason.
Secondary pulmonary arterial hypertension (SPAH) either is caused by or occurs because of another condition. The conditions include chronic heart or lung disease, blood clots in the lungs, or a disease like scleroderma (skler-o-DER-ma).
About 300 new cases of PPAH are diagnosed in the United States each year. SPAH is much more common.
Doctors have learned a lot about PAH in recent years. More treatments are now available. Researchers are also studying several promising new treatments that may prolong lives as well as improve the quality of life for people living with PAH.
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