>>TH 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.<<
snip, emphasis mine
Ya know, if CTRX is essentially a one trick pony, 50,000 patients does not constitute much of a market. And that's if they find them all, and vanguish all competitors. That would be $500 million in revenue. Let's say they manage 1/4 of that in three years, peaking in six years at half of that (don't know if improvements in diagnosis are expected). If they can get good margins, it'll be enough, if it's to be priced anywhere near existing treatments. You have any insight or knowledge about this?
Might have to listen to a CC or presentation. I'm curious about the potential sales numbers as the stock tanks and starts looking cheap. Is there potential for Ventavis in other indications?
CTX-100 struck me as having a wider market, but perhaps margins would not be as good?
TIA & Cheers, Tuck |
