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Discovery Laboratories Inc. released positive key data from its support trial of Surfaxin in respiratory distress syndrome in premature infants.

The trial was designed as a noninferiority study comparing Surfaxin to the approved product Curosurf, something the company called "the gold standard of pulmonary surfactants." Although a pivotal trial is still under way, positive trial data are never unwelcome.

"Anytime you can provide additional safety, patient exposure and efficacy data to the FDA, it can do nothing but help the package," Robert Capetola, president and CEO of Discovery, told BioWorld Today.

Discovery's stock (NASDAQ:DSCO) rose 59 cents Thursday, or 13.3 percent, to close at $5.04.

Specifically, regarding the endpoint of the number of living patients with no bronchopulmonary dysplasia at 28 days of age, Surfaxin was statistically equivalent to Curosurf and demonstrated a roughly 14 percent relative difference in favor of Surfaxin. When looking at all-cause mortality at 28 days of age, Surfaxin was again equivalent and showed an approximate 27 percent relative difference in its favor.

The trial enrolled 252 patients at 23 sites in the U.S., UK, Spain, France, Poland, Hungary, Portugal and Canada. However, the company said further evaluation of secondary endpoints and safety data is under way and details "will be generated over the next month or two." Discovery plans to present a complete analysis of data at the European Society for Pediatric Research meeting in Bilbao, Spain, in September.

For now, investors and observers will have to be satisfied knowing Surfaxin, a synthetic surfactant, was shown to be at least equivalent in the trial to Curosurf, a pig-lung extract. Surfactants are produced naturally in the lungs and help facilitate respiration by modifying the surface tension of the fluid normally present in the lung's alveoli. Premature babies possess a lack of natural surfactant and are in danger of lung collapse, Discovery said.

The idea behind Surfaxin is to circumvent the problems with animal-derived surfactants - namely, limited quantities and the risk of animal-associated diseases, Discovery said.

The pivotal trial is designed to enroll 1,500 patients. Data from the trial are scheduled to be released in the fourth quarter. The trial compares Surfaxin to GlaxoSmithKline plc's Exosurf in one arm and to Abbott Laboratories' Survanta in the other.

Capetola told listeners on a conference call the annual revenue in the neonatal area for Surfaxin would be about $150 million to $200 million, although he said the market "is much greater than that, but most babies in the world don't get treated" because of lack of medicine or funds.

If approved in the neonatology area, Discovery would market the product itself, although partner Quintiles Transnational Corp. would pay for it, Capetola said. For Europe and Latin America, Discovery has an alliance with Laboratorios del Dr. Esteve SA, of Barcelona, Spain.

Discovery also has Surfaxin in a Phase III trial ongoing in meconium aspiration syndrome and a Phase IIb trial in acute respiratory distress syndrome. Also, it just started a prophylactic meconium aspiration syndrome trial in South Africa, Capetola said. It is developing an aerosol form of Surfaxin and is "readying itself for a clinical trial at this time," although when, exactly, it might start Capetola wasn't able to say.

The company ended the first quarter with $14.2 million in cash and investments and reported a net loss of $4.5 million. It has a $10 million line of credit with Quintiles, and John Cooper, senior vice president, chief financial officer, said it has money to get "into the second quarter of next year."

At which time it should have reached some important milestones, such as data from its pivotal Surfaxin trial, Cooper said. There has been some interest in Surfaxin from not only the National Institutes of Health in Bethesda, Md., and the U.S. government, but also from Canada as a treatment for severe acute respiratory syndrome. The company remains focused on its non-animal surfactant platform, however.

"Our goal is to make humanized pulmonary surfactants to obviate the problems of putting animalized products into human beings," Capetola said in the call. "That's our reason for developing this technology."