Actelion Launches Increased Strength Formulation of Ventavis (Iloprost) for Pulmonary...

Tue Sep 1, 2009 4:00pm EDT
 
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Actelion Launches Increased Strength Formulation of Ventavis (Iloprost) for
Pulmonary Arterial Hypertension in the United States

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)).



SOURCE  Actelion Pharmaceuticals US, Inc.

Danielle Bertrand of WeissComm Partners, +1-415-946-1056,
dbertrand@wcpglobal.com, for Actelion Pharmaceuticals US, Inc.

 

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