<b>This company has done its part in trying to bring the drug to the market. Will you do your part as a CF patient and participate in the trial?
Don't forget - more companies would be developing drugs if they knew that they could recoup costs from countries in Europe and Canada. But due to price caps, there is less of an incentive.
</b>
Inspire starts phase III trial on cystic fibrosis drug
Friday July 28, 2:12 pm ET
Inspire Pharmaceuticals has launched phase III human testing on a cystic fibrosis drug that could loom large for the Durham company.
The trial, which will last for 48 weeks, will test the effectiveness and safety of denufosol tetrasodium in 350 patients with mild cystic fibrosis.
Two phase III human trials must be completed before a drug can be submitted to the U.S. Food and Drug Administration for approval. Inspire (NASDAQ: ISPH - News) will launch its second phase III trial on denufosol tetrasodium in 2007. It will be a two-year study designed to see if the drug has any cancer-causing effects. Inspire said in January it hopes to have its phase III results compiled by 2009.
Cystic fibrosis is a disease that leads to the buildup of a thick mucus in the lungs, leading to chronic infections. Denufosol tetrasodium is designed to stimulate a response in the lungs that thins the mucus. The drug essentially activates cells in the lung's airways that perform the mucus-thinning work usually done by cells that are shut down by cystic fibrosis.
"This is a critical development for CF patients and could represent an entirely new way to correct the basic defect in cells that line the airways," said Robert J. Beall, president and CEO of the Cystic Fibrosis Foundation. "Reaching phase III is a significant achievement - for any drug - and we look forward to the study results and what it could mean for CF patients' lives."
While Inspire has yet to release any estimates of the market potential for denufosol, a similar drug produced by Genentech recorded 2005 sales of $187 million.
The uncertain future of Inspire's lead drug candidate, a dry eye treatment called diquafosol tetrasodium, could place even greater importance on the success of the cystic fibrosis drug in Inspire's future. The company has yet to develop and bring a drug of its own to market, though it is selling two drugs it has licensed from Allergan Inc.: the eye-itching treatment Elestat and a dry-eye drug called Restasis.
Inspire's stock plummeted 35 percent in December after the FDA for the second time refused to approve the company's dry eye drug. At a meeting in March, FDA officials requested more information on the drug. Inspire still is in the process of gathering that information, according to company spokesman Dan Budwick.
Inspire, which employs 170 people, has other drugs in development, but none are beyond phase II human trials.
Published July 28, 2006 by the Triangle Business Journal
Don't forget - more companies would be developing drugs if they knew that they could recoup costs from countries in Europe and Canada. But due to price caps, there is less of an incentive.
</b>
Inspire starts phase III trial on cystic fibrosis drug
Friday July 28, 2:12 pm ET
Inspire Pharmaceuticals has launched phase III human testing on a cystic fibrosis drug that could loom large for the Durham company.
The trial, which will last for 48 weeks, will test the effectiveness and safety of denufosol tetrasodium in 350 patients with mild cystic fibrosis.
Two phase III human trials must be completed before a drug can be submitted to the U.S. Food and Drug Administration for approval. Inspire (NASDAQ: ISPH - News) will launch its second phase III trial on denufosol tetrasodium in 2007. It will be a two-year study designed to see if the drug has any cancer-causing effects. Inspire said in January it hopes to have its phase III results compiled by 2009.
Cystic fibrosis is a disease that leads to the buildup of a thick mucus in the lungs, leading to chronic infections. Denufosol tetrasodium is designed to stimulate a response in the lungs that thins the mucus. The drug essentially activates cells in the lung's airways that perform the mucus-thinning work usually done by cells that are shut down by cystic fibrosis.
"This is a critical development for CF patients and could represent an entirely new way to correct the basic defect in cells that line the airways," said Robert J. Beall, president and CEO of the Cystic Fibrosis Foundation. "Reaching phase III is a significant achievement - for any drug - and we look forward to the study results and what it could mean for CF patients' lives."
While Inspire has yet to release any estimates of the market potential for denufosol, a similar drug produced by Genentech recorded 2005 sales of $187 million.
The uncertain future of Inspire's lead drug candidate, a dry eye treatment called diquafosol tetrasodium, could place even greater importance on the success of the cystic fibrosis drug in Inspire's future. The company has yet to develop and bring a drug of its own to market, though it is selling two drugs it has licensed from Allergan Inc.: the eye-itching treatment Elestat and a dry-eye drug called Restasis.
Inspire's stock plummeted 35 percent in December after the FDA for the second time refused to approve the company's dry eye drug. At a meeting in March, FDA officials requested more information on the drug. Inspire still is in the process of gathering that information, according to company spokesman Dan Budwick.
Inspire, which employs 170 people, has other drugs in development, but none are beyond phase II human trials.
Published July 28, 2006 by the Triangle Business Journal