Primary Arterial Hypertension News - Menu New Ventavis(R) Data to Be Presented at American Thoracic Society's International Conference
SOUTH SAN FRANCISCO, Calif., May 16 /PRNewswire-FirstCall/ -- CoTherix, Inc. (Nasdaq: CTRX - News) today announced that data on Ventavis® (iloprost) Inhalation Solution will be presented at the annual International Conference of the American Thoracic Society (ATS), May 20-25 in San Diego. Ventavis® is marketed in the United States by CoTherix for the treatment of pulmonary arterial hypertension, a highly debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries of the lungs, in patients with NYHA Class III or IV symptoms.
The following data on Ventavis will be presented on Sunday, May 22 from 10:45 a.m. to 12:15 p.m. PT, during the ATS Thematic Poster Session for Pulmonary Hypertension. Abstracts include:
-- "Efficacy of Inhaled Iloprost in NYHA Class IV Pulmonary Hypertension
(PH)" (H. Olschewski, MD, et al.); Poster K28
-- "Safety, Dosing, and Clinical Benefit of 2-Year Therapy with Inhaled
Iloprost" (H. Olschewski, MD, et al.); Poster K29 -- "Maintenance of Clinical Benefit of Inhaled Iloprost during Trough
Periods" (L.J. Rubin, MD, et al.); Poster K61 Four additional abstracts related to Ventavis will be presented at the meeting. For more information visit booth #740. About Ventavis Ventavis® (iloprost) Inhalation Solution was approved by the U.S. Food and Drug Administration (FDA) on December 29, 2004 for the treatment of PAH (WHO Group I) in patients with NYHA Class III or IV symptoms. Ventavis is the newest entry into the prostacyclin class of PAH treatments. Prior to the introduction of Ventavis, prostacyclin therapies for PAH required continuous delivery through subcutaneous or intravenous routes -- invasive treatments which can be difficult to tolerate and/or require complicated maintenance. Now, with Ventavis, PAH patients can benefit from a non-invasive, inhaled treatment option. In clinical studies of Ventavis as monotherapy, common adverse reactions due to Ventavis included: vasodilation (flushing, 27%), cough (39%), headache (30%), flu syndrome (14%), nausea (13%), trismus (12%), hypotension (11%), insomnia (8%) and syncope (8%); other serious adverse events reported with the use of Ventavis included congestive heart failure, chest pain, superventricular tachycardia, dyspnea, peripheral edema, and kidney failure. Because of the risk of syncope, vital signs should be monitored while initiating Ventavis. Dose adjustments or a change in therapy should be considered if exertional syncope occurs. Ventavis should not be initiated in patients with systolic blood pressure lower than 85 mm Hg. Stop Ventavis immediately if signs of pulmonary edema occur, this may be a sign of pulmonary venous hypertension. Ventavis has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections. For important additional information concerning the safety and use of Ventavis, please see the prescribing information available at www.4Ventavis.com. About PAH PAH affects an estimated 50,000 patients in the United States, with only about 15,000 diagnosed and under treatment. Its cause may be unknown, or result from other diseases that cause a restriction of blood flow to the lungs, including scleroderma, HIV and lupus. Symptoms of the disease include fatigue, shortness of breath on exertion, chest pain and dizziness. Left untreated, the median survival time following diagnosis may be as short as three years. About Cotherix, Inc. CoTherix, Inc. is a biopharmaceutical company focused on licensing, developing and commercializing therapeutic products for the treatment of cardiopulmonary and other chronic diseases. CoTherix's Ventavis (iloprost) Inhalation Solution was approved by the FDA in December 2004 for the treatment of pulmonary arterial hypertension, a highly debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries of the lungs, in patients with NYHA Class III or IV symptoms. Ventavis is an inhaled formulation of iloprost, a synthetic compound that is structurally similar to prostacyclins. CoTherix and the CoTherix logo are trademarks of CoTherix, Inc. Ventavis is a trademark of Schering AG, Germany. More information can be found at www.cotherix.com. Forward-Looking Statements The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. The results of initial clinical trials do not necessarily predict the results of later stage clinical trials. Data collected from clinical trials are subject to varying interpretation, and may be deemed insufficient by the FDA or other regulatory bodies reviewing applications for market approval or label expansion (including combination therapy) of any product or product candidate. We cannot guarantee that any product candidate, including any combination therapy, will receive FDA or other regulatory approval or that we will seek any such approval. All forward-looking statements included in this press release are based upon information available to us as of the date hereof, and we assume no obligation to update any such forward-looking statement as a result of new information, future events or otherwise. Our actual results could differ materially from our current expectations. Factors that could cause or contribute to such differences include, but are not limited to, factors described from time to time in our filings with the Securities and Exchange Commission, including those discussed in the "Risk Factors and Other Uncertainties" section of our Annual Report on Form 10-K filed on March 31, 2005.
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Source: CoTherix, Inc.
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