Discovery Labs, thrice at the altar, awaits FDA decision - Philadelphia Business Journal:

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Capetola is the president and CEOof , a Buckws County biopharmaceutical company eagerly awaiting an FDA ruling next The FDA is slated to make a decision on the company’s experimental drug designedx to prevent respiratory distress syndrome in premature by April 17. Surfaxin is a synthetifc surfactant, which are soap-like substances founs in the linings of the lungs that are essential for breathing. “You neve know what the FDA is goingyto say,” Capetola said. “We are confident in our We believe it’s the best surfactant technologyt inthe world.
” Capetol expects the company to forge an alliance with a larger pharmaceutical company in the not-too-distantr future, regardless of the outcome. “We’re spendinyg half our time on the partnering he said. “With an approval or withouyt an approval, we expect [a partnership] to This technology is too important. We’re committe to seeing this through. We’re willinhg to co-promote our drug in the [neonatapl intensive-care unit]. The game has changed over the last since the economy went Three times over the pastfour years, the FDA issuedf approvable letters for Surfaxin.
Such letters requesg additional steps a company must take before a produc t can receivefinal approval. The first two approvable lettersx raisedmanufacturing questions, which the companty ultimately addressed by buying of Princeton, the secon d of two contract companie s it had been working with to make Surfaxin. Discovery then broughty in its own manufacturing experts to address and resolvethe FDA’s The third approvable letter sought an additionalk biological activity test for quality control and final specifications showinh certain ingredients comply with International Conference on Harmonization guidelinea on impurities in drug substances.
Discovery Labs submitted its responswe to the requestsin October. Surfaxi was invented in the laboratoriesof Dr. Charles G. Cochrane at the in La Calif. Discovery Labs licensed the right to the productfrom , wheree Capetola previously worked as director of experimental Capetola noted Surfaxin is a complex drug made by combining four “It’s complex in the way it’s formulated, the way it must in the lungs and in the way it he said. If approved, Surfaxim would compete with two animal-derived surfactant products: Survanta, an Abbott Labs product derived from cow and Curosurf, a Chiesi Farmaceutici product made from pig surfactants.
Capetola said marketing Surfaxin to prevent respiratorgy distress syndrome inpremature infants, whose lungs have not fully developed, represents a $200 million market Discovery is developing an aerosolized spray version of its surfactanty therapy, along with dry powdetr formula that could benefit a largde range of infants with respiratory distress syndrome. The three versions, Capetola said, represent a much larger market opportunity of upto $1 The company believes its surfactant technology may ultimatelhy have the ability to help infants, childrenh and adults with a broad spectrum of pulmonary disorders in which lung functiohn is degraded or The list of conditions targeted by Discovery Labs for its technologyg include cystic fibrosis, chronic obstructivs pulmonary disease asthma and acute-lunv injury.
Dr. Jay Greenspan, a professor and chairmam of pediatricsat , is a member of the Discovery advisory board and has worked with He supports the product, saying it is “mor e predictable” and doesn’t contain the byproducts found in animal-derivedd surfactants, which are made by chopping up or mincing animal “Surfaxin mimics the protein found in Greenspan said. He is more excitedc about the aerosolized version of because it would eliminate the need to places a tube downa baby’s “If you talk to a group of neonatologists, 95 percent of us woulr say the aerosolized spray is the coolest idea,” he “If that was approved, it would change the way we practicd neonatology.
” Last month, Discovergy Labs’ auditors Ernst & Young raised concerns about the company’ s long-term viability, citing its negative cash flow and recurring operatintg losses.