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Actelion Launches Increased Strength Formulation of Ventavis (Iloprost) for Pulmonary Arterial Hypertension in the United States
Date:9/1/2009

SOUTH SAN FRANCISCO, Calif., Sept. 1 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc., today announced the first commercial sales of a new 20 microgram per milliliter (mcg/mL) formulation of Ventavis(R), for the treatment of New York Heart Association Class III and IV pulmonary arterial hypertension (PAH). This increased strength formulation delivers the same dose of Ventavis in half the volume, which is expected to reduce inhalation time and further support patient compliance. The 20 mcg/mL formulation of Ventavis(R) is available immediately for pre-order, and fulfillment of initial prescriptions by specialty pharmacies is anticipated beginning the week of September 14.

"Ventavis(R) is the leading inhaled prostacylin therapy for patients with PAH, and this stronger formulation is a major advancement. Together with the easy-to-use, compact inhalation device called the I-neb AAD System, it will offer even more convenience to patients using Ventavis," said Kirk Taylor, M.D., Senior Vice President, U.S. Medical Group at Actelion Pharmaceuticals US.

"Ventavis(R) is the inhaled prostacyclin with the most extensive clinical experience, and is an extremely important treatment option for many patients with PAH. Shortening treatment times by 50% with the new 20 mcg/mL concentration will significantly benefit my patients," said Dr. Richard Channick, Professor of Medicine, Pulmonary and Critical Care Division, UC San Diego Medical Center and Editor-in-Chief, Advances in Pulmonary Hypertension.

About Ventavis(R)

Ventavis(R) is indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients with NYHA Class III or IV symptoms. In August 2009, the U.S. Food and Drug Adminsitration approved the new 20 mcg/ml formulation of Ventavis(R).

Ventavis(R) is an inhaled synthetic analog of prostacyclin (PGI2) that produces potent pulmonary vasodilation and inhibits platelet aggregation, among other benefits. Prostacyclin functions as a hormone, binding to receptors on smooth muscle cells, thereby affecting their function. Prostacyclin has multiple physiological effects, including vasodilation, inhibition of platelet aggregation, antiproliferation, anti-inflammation, and enhanced cardiac contractility.

In January 2007, Actelion announced the successful completion of its cash tender offer for shares of CoTherix, Inc., thereby strengthening its PAH franchise by adding Ventavis(R) to its product offerings in the United States. Bayer Schering Pharma - the inventor of Ventavis(R) - markets the drug as the first inhaled prostacyclin in Europe and other countries outside the US.

More information is available at www.4ventavis.com.

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.

PAH is associated with structural changes in both the pulmonary vasculature and the right ventricle. Recent advances (1) in the understanding of the pathogenic factors leading to the pulmonary vascular disease have led to the development of new therapies targeting specific pathways (the prostacyclin pathway; the endothelin pathway; and the nitric oxide pathway) (2). The available therapies have positive effects in PAH, but they do not provide a cure, and in many patients the disease will progress. PAH remains a serious life-threatening condition (2,3). Early recognition and an understanding of the selection and timing of therapeutic options remain critical elements in the optimal management of patients with this disorder.

References

  1. Farber HW; Loscalzo J. Mechanisms of disease: pulmonary arterial hypertension. N. Eng. J. Med. 2004; 351:1655-65.
  2. Humbert M; Sitbon O; Simonneau G. Treatment of pulmonary arterial hypertension. N. Eng. J. Med. 2004;351:1425-36.
  3. Humbert M; Morrell NW; Archer SL; et al. Cellular and molecular pathobiology of pulmonary arterial hypertension. J. Am. Coll. Cardiol. 2004; 43: Suppl. 12: 13S-24S.

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, 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's over 2000 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI(R)).


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SOURCE Actelion Pharmaceuticals US, Inc.
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