>>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® (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."
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 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.<<
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