Tracleer and PPH News CoTherix's Ventavis(R) Commercially Available for the Treatment of Pulmonary Arterial Hypertension
- First Prescriptions Filled for New Inhaled Therapy SOUTH SAN FRANCISCO, Calif., March 22 /PRNewswire/ -- CoTherix, Inc. announced today the commercial availability of Ventavis® (iloprost) Inhalation Solution in the U.S. for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in patients with NYHA Class III or IV symptoms. PAH is a progressive, highly debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries.
"Now that Ventavis is broadly available in the U.S., patients can receive the benefits of a prostacyclin without the needles and catheters associated with the infused prostacyclin treatments," said Donald J. Santel, Chief Executive Officer of CoTherix, Inc. "We're pleased to deliver this important therapy to the PAH community ahead of our formal launch in early April." Santel added, "Based on the positive results from our STEP trial evaluating the combination of Ventavis added to Tracleer therapy, we believe there is an opportunity for Ventavis to be used early in the course of the disease." "As part of our launch plan for Ventavis, we have activated a sales force of 23 highly trained individuals, established a hotline to assist physicians and patients in attaining reimbursement, and secured ample drug to meet the anticipated initial patient demand. We believe we have all the components in place to serve this important market," said Thomas L. Feldman, President and Chief Business Officer of CoTherix, Inc. "It's extremely encouraging to see that third-party payers are approving reimbursement for Ventavis and prescriptions have been filled." Healthcare professionals can contact 877-4VENTAVIS (877-483-6828) to receive additional information on Ventavis. 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 are difficult to tolerate and/or require complicated maintenance. Now, with Ventavis, PAH patients can benefit from a non-invasive, inhaled treatment option. In recently released results from the STEP clinical study, the addition of Ventavis to Tracleer® (bosentan) therapy provided statistically significant improvements in several key clinical parameters. Ventavis is currently marketed by Schering AG in several European countries and Australia. CoTherix licensed exclusive rights to develop and commercialize Ventavis in the U.S. from Schering AG in October 2003 and filed a New Drug Application (NDA) in June 2004. In August 2004, CoTherix's NDA was accepted by the FDA and granted priority review with orphan drug designation. Safety Profile In previous clinical studies of Ventavis monotherapy, common adverse reactions due to Ventavis included: vasodilation (flushing, 27%), cough (39%), headache (30%), flu syndrome (14%), nausea (13%), jaw pain (12%), hypotension (11%), insomnia (8%) and syncope (8%); other serious adverse events reported with the use of Ventavis included congestive heart failure, chest pain, supraventricular 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. Ventavis has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections. 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, including statements regarding our expectations, beliefs, hopes, intentions or strategies such as, without limitation, statements about prescribing, trial results, the sufficiency of our supply of Ventavis, and patient demand. The results of initial clinical trials do not necessarily predict the results of later clinical trials, and it is not known whether future studies will confirm results of the STEP trial. 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. We cannot anticipate future success of our sales efforts and we have not and may not generate any significant revenues. Factors that could cause or contribute to such differences include, but are not limited to, factors discussed in the "Risk Factors" section of our Registration Statement on Form S-1 filed on January 20, 2005 and the related prospectus filed pursuant to Rule 424(b)(4) on February 10, 2005.
-----------------------------------------
Source: CoTherix, Inc.
First Ever Placebo-Controlled Study in Patients With Eisenmenger's Syndrome to Show Benefit of Treatment Published in Circulation
BREATHE-5 study shows exercise capacity and haemodynamics improved for patients treated with bosentan
ALLSCHWIL, SWITZERLAND -- July 5, 2006 -- A study published in Circulation showed that patients with Eisenmenger's syndrome, a severe form of pulmonary arterial hypertension (PAH) developed as a complication of a congenital heart defect, responded positively to treatment with bosentan (Tracleer®).1
Eisenmenger's syndrome is the most advanced form of PAH related to congenital heart disease, exercise capacity is particularly poor even in comparison to other forms of Congenital Heart Disease (CHD) and is associated with organ damage and a higher likelihood of premature death.2
The study, BREATHE-5 (Bosentan Randomized trial of Endothelin Antagonist THErapy-5), investigated 54 patients over a 16 week period and is the first ever multi-centre, randomized, double blind, placebo-controlled study conducted in this very sick group of patients to show treatment benefit.1
Treatment with bosentan significantly improved patients exercise capacity, measured by the six-minute walk test, resulting in a treatment effect of 53.1 meters (p=0.008).1
Haemodynamics, measured as pulmonary vascular resistance (PVRi), also improved in bosentan patients resulting in a statistically significant treatment effect (p=0.0383).1
Professor Nazzareno Galiè, from the Institute of Cardiology, University of Bologna, and the lead author of the study comments:
"It is impressive to see that in this group of sick patients exercise capacity can be improved significantly over a short period of time without compromising oxygenation. These findings are encouraging for patients with a condition where currently there is no therapeutic option."
The study's primary endpoint was to assess the safety of bosentan in these patients, as assessed by mean oxygen saturation. The study results show bosentan did not worsen oxygen saturation with a treatment effect of 1.0% on oxygen saturation (Sp02). 1
All patients enrolled in the study had Eisenmenger's syndrome and were in WHO Class III. Improvement from WHO Class III to WHO Class II was seen in two patients in the placebo group (13%) compared with 13 patients in the bosentan group (35%). One patient in the placebo group (6%) and one patient in the bosentan group (3%) deteriorated to WHO class IV, all other patients remained in WHO class III.1
The safety profile of bosentan, in this study, was comparable to that observed in previous clinical trials in PAH.1
Bosentan is an oral dual endothelin receptor antagonist which is currently licensed for the treatment of pulmonary arterial hypertension (PAH Functional Class III and IV in the United States, Class III in Europe) to improve exercise ability and decrease the rate of clinical worsening.3 The results of the BREATHE-5 study in patients with PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology are currently under review with the European Medicines Agency (EMEA).
About the study
BREATHE-5 was the first trial designed as a multi-centre, double-blind, randomised (2:1), placebo-controlled study to assess the effects of bosentan on systemic oxygen saturation, pulmonary and systemic haemodynamics and exercise capacity in patients with Eisenmenger's syndrome
Fifty-four patients were randomised 2:1 to bosentan (n=37) or placebo (n=17) for 16 weeks. The trial was conducted in 15 centres in Europe, North America and Australia.
About Eisenmenger's syndrome
Eisenmenger's syndrome is a progressive heart condition and occurs in people who have a congenital heart defect or 'hole in the heart'. Prior to the development of Eisenmenger's syndrome, the heart defect allows blood to flow from the left ventricle to the right (left-to-right shunt), which increases blood flow through the lungs. Over time damage to the pulmonary vessels causes increased resistance to the blood flow to the lungs (pulmonary hypertension) leading to a reversal of the shunt, with blood flowing from the right to the left side. This phenomenon of pulmonary hypertension and right to left shunting is termed 'Eisenmenger's syndrome', or 'Eisenmenger's physiology'.
This flow of blood from the right to the left causes the most recognizable symptom of Eisenmenger's syndrome, a blue tinge to the skin (cyanosis) resulting from low blood oxygen concentration. Currently, no intervention significantly improves the clinical status of these patients.
REFERENCES:
1. Galie N et al. Bosentan therapy in patients with Eisenmenger syndrome: a multi-centre, double-blind randomised placebo-controlled study. Circulation 2006.
2. Diller GP et al. Exercise intolerance in adult congenital heart disease: comparative severity, correlates, and prognostic implication. Circulation. 2005;112:828-35.
3. Tracleer SPC
SOURCE: Actelion
|
