SOUTH SAN FRANCISCO, Calif., April 5 /PRNewswire-FirstCall/ -- CoTherix, Inc. today announced a collaborative research and development agreement with Quadrant Drug Delivery, Limited to develop an extended-release formulation of CoTherix's product, Ventavis(R) (iloprost) Inhalation Solution. The goal of this initiative is to reduce the frequency and duration of dosing. Financial terms of the agreement were not disclosed. Ventavis is marketed by CoTherix in the U.S. for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization Group I) in patients with NYHA Class III or IV symptoms.
"This agreement highlights our strategy to develop a second-generation product and maintain our leadership position in delivering effective, inhaled therapies for PAH," said Donald J. Santel, Chief Executive Officer of CoTherix, Inc. "This announcement also underscores our commitment to the PAH community to help patients better manage this serious disease."
"Our goal is to provide greater patient convenience by reducing the number of doses required per day and enabling dose delivery in a single breath using a pocket-sized device," said Curtis Ruegg, Ph.D., Senior Vice President of Technical Operations of CoTherix, Inc. "Ventavis is extremely potent and stable, making it an ideal candidate for extended-release reformulation."
"We are delighted to have this opportunity to apply our dry powder formulation technologies developed over the last 10 years to help create an extended-release formulation of Ventavis," said Mr. Raj Uppal, Chief Executive Officer of Quadrant Drug Delivery, Limited. "By coupling our expertise in drug formulation and stabilization technologies with our experience in the pulmonary delivery area, we are confident we can assist CoTherix in improving the Ventavis formulation."
Ventavis(R)(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(R) (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 United States 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.
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(R) (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 http://www.cotherix.com/.
About Quadrant Drug Delivery, Ltd.
Quadrant Drug Delivery, Ltd. is a privately owned company based in Nottingham, U.K. It provides specialized drug formulation and stabilization technologies to the pharmaceutical and biotechnology industries with particular emphasis on dry powder drug delivery to the lungs. Quadrant's proprietary approaches can improve product performance by increasing the efficiency of delivery of medicines to the lungs and systemic circulation as well as stabilizing labile molecules offering the potential for room temperature stable products.
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.
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. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the future development and commercialization of an extended-release formulation of Ventavis, the success of development efforts and the potential for delivery using a hand-held device. 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. We can not guarantee that any product candidate, including any reformulation of Ventavis, will receive FDA or other regulatory approval or that we will seek any such approval. Factors that could cause or contribute to such differences include, but are not limited to, factors discussed in the "Risk Factors and Other Uncertainties" section of our Annual Report on Form 10-K filed on March 31, 2005.