Ventavis (Iloprost) in pulmonary arterial hypertension receives US
approval for increased 20 mcg/ml
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ ALLSCHWIL, SWITZERLAND - 10 August 2009 - Actelion Ltd (SIX: ATLN)announced today that the US Food and Drug Administration (FDA) hasapproved a new 20 microgram per milliliter (mcg/ml) formulation ofVentavis® as a therapy for New York Heart Association Class III andIV pulmonary arterial hypertension (PAH). This new increased 20mcg/ml strength formulation will deliver the same dose in half thevolume which is expected to reduce inhalation time and furthersupport patient compliance.The approval was based on the submission of technical data showingthat the new formulation did not alter the functional characteristicsof the delivery system or the emitted dose to the patient.Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelioncommented: "This is another major improvement for Ventavis® in the USand for the patients who use this important inhaled therapy for PAH.The only inhaled prostacyclin therapy to show significant patientimprovement measured by both exercise capacity and improvement inNYHA Functional Class. [1] In 2008, Actelion successfully implementedan improved cleaning protocol for the device which significantlyreduced the time each patient spent on maintenance."Jean-Paul added: "We have now been successful with this newstrengthened formulation offering additional convenience for USpatients using Ventavis®. We will continue our commitment toVentavis® as well as our portfolio of PAH programs in order toachieve further improvements for the PAH community."Dr. Harold Palevsky, Professor of Medicine at the University ofPennsylvania School of Medicine, Chief of the Pulmonary, Allergy andCritical Care Division, and Director of the Pulmonary VascularDisease Program at Penn Presbyterian Medical Center in Philadelphiacommented: "Ventavis is an important treatment option for manypatients with PAH. Decreasing the time required per inhalation willallow these patients more time to focus on activities that areimportant in their lives. In addition, the new formulation shouldhelp maintain patient compliance, an important part of any PAHtherapy"About Ventavis®Ventavis® is indicated for the treatment of pulmonary arterialhypertension (WHO Group 1) in patients with NYHA Class III or IVsymptoms.In January 2007, Actelion announced the successful completion of itscash tender offer for shares of CoTherix, Inc., thereby strengtheningits PAH franchise by adding Ventavis® to its product offerings in theUnited States. Bayer Schering Pharma - the inventor of Ventavis® -markets the drug as the first inhaled prostacyclin in Europe andother countries outside the US. ###Notes to Editor:About Pulmonary Arterial Hypertension (PAH)Pulmonary arterial hypertension (PAH) is a chronic, life-threateningdisorder characterized by abnormally high blood pressure in thearteries between the heart and lungs of an affected individual. Thefunction of the heart and lungs is severely compromised, manifestedby a limited exercise capacity, and, ultimately, a reduced lifeexpectancy. Approximately 100,000 people in Europe and the UnitedStates are afflicted with either primary or secondary forms of thedisease related to conditions or tissue disorders that affect thelungs, such as scleroderma, lupus, HIV/AIDS or congenital heartdisease.PAH is associated with structural changes in both the pulmonaryvasculature and the right ventricle. Recent advances [2] in theunderstanding of the pathogenic factors leading to the pulmonaryvascular disease have led to the development of new therapiestargeting specific pathways (the prostacyclin pathway; the endothelinpathway; and the nitric oxide pathway) [3]. The available therapieshave positive effects in PAH, but they do not provide a cure, and inmany patients the disease will progress. PAH remains a seriouslife-threatening condition [3,4]. Early recognition and anunderstanding of the selection and timing of therapeutic optionsremain critical elements in the optimal management of patients withthis disorder.About Ventavis®Ventavis® (iloprost) is an inhaled synthetic analog of prostacyclin(PGI2) that produces potent pulmonary vasodilation and inhibitsplatelet aggregation, among other benefits. Prostacyclin functions asa hormone, binding to receptors on smooth muscle cells, therebyaffecting their function. Prostacyclin has multiple physiologicaleffects, including vasodilation, inhibition of platelet aggregation,antiproliferation, anti-inflammation, and enhanced cardiaccontractility. Ventavis® is an inhaled synthetic prostacyclin whichhas been shown to: * Significantly increase (p = 0.0033) patient improvement after 12 weeks of treatment compared to baseline on a composite endpoint of improved exercise capacity 30 minutes after dosing, improvement of at least one NHYA class and no clinical deterioration. * Significantly improve 6-minute walk distance at week 12 with a 10% or greater increase in individual walk distance (p < 0.01). * Significantly improve patients' functional class at week 12 (p = 0.03).For patients with PAH (WHO Group 1) with NYHA Class III or IVsymptoms [1]References 1. Ventavis® Prescribing Information 2. Farber HW; Loscalzo J. Mechanisms of disease: pulmonary arterial hypertension. N. Eng. J. Med. 2004; 351:1655-65. 3. Humbert M; Sitbon O; Simonneau G. Treatment of pulmonary arterial hypertension. N. Eng. J. Med. 2004;351:1425-36. 4. 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 LtdActelion Ltd is a biopharmaceutical company with its corporateheadquarters in Allschwil/Basel, Switzerland. Actelion's first drugTracleer®, 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 keymarkets worldwide, including the United States (based in South SanFrancisco), the European Union, Japan, Canada, Australia andSwitzerland. Actelion, founded in late 1997, is a leading player ininnovative science related to the endothelium - the single layer ofcells separating every blood vessel from the blood stream. Actelion'sover 2000 employees focus on the discovery, development and marketingof innovative drugs for significant unmet medical needs. Actelionshares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) aspart of the Swiss blue-chip index SMI (Swiss Market Index SMI®).For further information please contact:Investor ContactRoland HaefeliVice President, Head of Investor Relations & Corporate CommunicationsActelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil+41 61 565 62 62+1 650 624 69 36http://www.actelion.comhttp://hugin.info/131801/R/1330336/316157.pdf --- End of Message ---Actelion Pharmaceuticals LtdGewerbestrasse 16 Allschwil SwitzerlandWKN: 936767; ISIN: CH0010532478; Index: SBIOM, SLIFE, SMCI, SMIEXP, SMIM, SPI, SPIEX;Listed: Main Market in SIX Swiss Exchange;
Datum: 10.08.2009 - 06:55 Uhr
Sprache: Deutsch
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