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Updated U.S. Product Labeling for Actelion Ltd. (ALIOF.PK)'s Veletri (Epoprostenol for Injection) Allows Patients to Prepare This Medication Up to a Week in Advance of Use for Pulmonary Arterial Hypertension


10/5/2010 11:43:22 AM

SOUTH SAN FRANCISCO, CA--(Marketwire - October 05, 2010) -

Actelion Ltd (SWISS: ATLN) today announced that the U.S. Food and Drug Administration (FDA) has approved additional in-use conditions for administration of Veletri®, an improved formulation of epoprostenol. The additional product information allows patients with moderate to severe pulmonary arterial hypertension (PAH) and PAH associated with the scleroderma spectrum of disease who do not respond adequately to conventional therapy that use Veletri® to prepare their medication up to seven days in advance (for concentrations of >9,000 to 30,000 ng/ml) and store filled cassettes refrigerated at 2°C to 8°C (36° to 46°F). Patients also have the option to administer Veletri® at room temperature immediately after dilution for up to 48 hours at concentrations greater than or equal to 30,000 ng/mL. Veletri® is the first and only intravenous prostacyclin for PAH that offers the flexibility of different preparation and storage options prior to administration.

Dr. Vallerie McLaughlin, Professor of Medicine and Director of Pulmonary Hypertension at the University of Michigan, commented: "Patients with more advanced PAH struggle daily with debilitating symptoms, such as shortness of breath, chest pain and chronic fatigue. I expect the improved convenience of Veletri's preparation and storage flexibility to significantly benefit these patients and make a difference in their everyday life."

In conjunction with the launch of Veletri®, which has been commercially available in the United States since April 2010, Actelion opened its fourth U.S. PAH patient registry. PROSPECT, the registry to PROSPECTively evaluate use of Veletri® in patients with PAH, is a multicenter, observational, U.S.-based registry and is currently registering patients.

Shal Jacobovitz, President of Actelion Pharmaceuticals US, Inc. commented: "Actelion has further characterized the stability of Veletri and followed through with the regulatory procedures resulting in this updated label. This allows physicians and patients in the U.S. to fully utilize the advantages offered by Veletri's stability profile."

Actelion will provide further information on Veletri® at the American Heart Association Scientific Sessions 2010 in Chicago with a poster entitled "Biocomparability of Two Formulations of Epoprostenol, Epoprostenol for Injection (ACT-385781A) and Flolan®, Via Pharmacokinetic Assessment Of Two Primary Metabolites."

The U.S. FDA approved the brand name Veletri® for the company's epoprostenol for injection therapy in August 2010. Consequently, Veletri® labeled product will be available in the fourth quarter of 2010. The registration process for Epoprostenol for Injection is ongoing outside the U.S., initially in France, also with Veletri® as the proposed brand name.

Notes to the editor:

About Veletri®
Veletri® is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy. Veletri® is now the first and only I.V. prostacyclin for PAH that offers up to once-weekly preparation. Fully diluted Veletri® now remains stable for up to seven days for concentrations greater than or equal to 9000 ng/ml if stored in cassettes in the refrigerator (36°F to 46°F; 2°C to 8°C). When stored in this manner, Veletri® can then be administered for up to 24 hours at room temperature at concentrations greater than or equal to 30,000 ng/mL. The enhanced stability of Veletri® means greater convenience and flexibility for patients.

Updated Prescribing Information (PI) is available at www.veletri.com

Accredo Health Group, Inc. is the sole specialty pharmacy provider of Veletri®. Accredo offers an enhanced level of personalized service to patients with chronic and complex disease, and will provide call center, nursing and reimbursement support services for patients using Veletri® and their healthcare providers. Patients and their physicians can call 1-866-FIGHTPH (1-866-344-4874), a hotline maintained by Accredo, to obtain benefit information available for Veletri®.

About Accredo Health Group
Accredo Health Group, Inc., a wholly-owned subsidiary of Medco Health Solutions, Inc., is one of the nation's largest specialty pharmacies dedicated to providing an enhanced level of personalized service to patients with chronic and complex disease. Drugs dispensed by Accredo frequently require special handling and clinical services to ensure the drugs are properly administered to promote patient safety and health.

About the PROSPECT Registry
PROSPECT, the registry to PROSPECTively evaluate use of Veletri® in patients with pulmonary arterial hypertension, is a multicenter, observational, U.S.-based registry. PROSPECT is designed to collect information about the demographics, disease characteristics, and dosing regimens of patients who are initiating or currently receiving Veletri®. Patients will be followed for up to one year, and data will be collected quarterly.

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. 

About Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion markets its medicinal products 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 2,400 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®).


For further information please contact:
Roland Haefeli
Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd
Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
http://www.actelion.com



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