Windtree Therapeutics Inc (WINT)

[turtlepower]

* Drug for premature infants has big sales potential
* FDA has not questioned effectiveness of Surfaxin
By Ransdell Pierson
NEW YORK, April 9 (Reuters) - The chief executive officer of Discovery Laboratories Inc said on Thursday his company's experimental drug, Surfaxin, could displace rival products used to treat a dangerous respiratory condition in premature infants.
"With proper partners in the future, Surfaxin has potential to be revolutionary in nature" and to generate blockbuster sales, Robert Capetola said in an interview.
The U.S. Food and Drug Administration is expected to make a decision by April 17 on Surfaxin, a coating designed to help the lungs of premature babies properly inflate and deflate. Many preemies require ventilation equipment because their lungs have inadequate natural lung coating, called surfactant.
Surfaxin combines three types of fats with a humanized protein -- meaning one that has the same arrangement of amino acids found in natural human surfactant. In clinical trials, it has reduced mortality in preemies compared with currently available pulmonary surfactants made with cow or pig proteins, or with fats alone.
The tiny company has been developing Surfaxin for 11 years, and has failed on several occasions since 2004 to win U.S. approval.
Capetola is hoping its latest marketing application will be the charm and noted the FDA has not questioned the effectiveness of Surfaxin. Instead, he said the agency has wanted to ascertain that manufacturing and purity standards were followed.
"We've addressed all their questions in what we consider a very satisfactory way," said Capetola, a former head of discovery research for Johnson & Johnson .
Tom Miller, Discovery Labs' senior vice president of commercialization, said current pulmonary surfactants now have annual U.S. sales of about $75 million and that Surfaxin could make them obsolete.
"Our goal is not to fight for limited market share, but to completely displace animal-derived surfactants," he said. "Globally, current products have annual sales of $200 million and we expect to eventually own that entirely."
But he noted that no clinical trials of Surfaxin have yet been started in Europe or Japan. (Reporting by Ransdell Pierson; Editing by Andre Grenon)

http://www.guardian.co.uk/business/feedarticle/8448248