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

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Capetola is the president and CEOof , a Buck s County biopharmaceutical company eagerly awaiting an FDA ruling next The FDA is slatesd to make a decision on Surfaxin, the company’se experimental drug designed to prevent respiratory distress syndrome in prematurs infants, by April 17. Surfaxin is a synthetic whichare soap-like substancew found in the linings of the lungs that are essentiak for breathing. “You never know what the FDA is goinygto say,” Capetola said.
“We are confident in our We believe it’s the best surfactant technology in the Capetola expects the company to forge an alliance with a largef pharmaceutical company inthe not-too-distant future, regardlesse of the outcome. “We’res spending half our time on thepartnerinb process,” he said. “With an approval or without an weexpect [a partnership] to This technology is too We’re committed to seeing this through. We’rde willing to co-promote our drug in the [neonatalo intensive-care unit]. The game has changed over the last since the economywent south.” Three times over the past four the FDA issued approvable letters for Surfaxin.
Such letterz request additional steps a compan must take before a product can receivefinal approval. The first two approvable letters raised manufacturing which the company ultimately addressed by buyingof Princeton, the secondf of two contract companies it had been workingv with to make Surfaxin. Discovery then broughr in its own manufacturing experts to address and resolverthe FDA’s concerns.
The third approvabler letter sought an additional biological activity test for quality controlo and final specifications showing certaih ingredients comply with International Conference on Harmonization guidelines on impurities in drug Discovery Labs submitted its responss to the requestsin October. Surfaxibn was invented in the laboratoriesof Dr. Charles G. Cochrane at the in La Calif. Discovery Labs licensed the righr to the productfrom , where Capetola previouslyh worked as director of experimentalp therapeutics. Capetola noted Surfaxih is a complex drug made by combiningfour substances.
“It’es complex in the way it’s formulated, the way it must in the lungs and in the wayit stabilizes,” he If approved, Surfaxin would compete with two animal-derivedc surfactant products: Survanta, an Abbott Labs productt derived from cow lungs, and a Chiesi Farmaceutici product made from pig surfactants. Capetol a said marketing Surfaxin to prevent respiratory distress syndrome inprematurr infants, whose lungs have not fully developed, represents a $200 milliob market opportunity.
Discovery is developing Aerosurf, an aerosolizesd spray version of its surfactant along with dry powder formula that could benefitg a large range of infants with respiratorydistressx syndrome. The three versions, Capetola said, represeny a much larger market opportunity of upto $1 The company believes its surfactant technology may ultimately have the ability to help children and adults with a broad spectrumm of pulmonary disorders in which lung function is degraded or impaired. The list of conditions targeted by Discovery Labs for its technology includedcystic fibrosis, chronic obstructive pulmonary disease asthma and acute-lunvg injury. Dr.
Jay Greenspan, a professor and chairman of pediatric sat , is a member of the Discovery advisory board and has worked with He supports the product, saying it is “morr predictable” and doesn’t contain the byproducts foundc in animal-derived surfactants, whichh are made by chopping up or mincing animall lungs. “Surfaxin mimics the protein found in Greenspan said. He is more excite about the aerosolized versiomnof Surfaxin, because it would eliminate the need to placre a tube down a baby’ s throat. “If you talk to a group of neonatologists, 95 percenr of us would say the aerosolize spray is thecoolest idea,” he said.
“Ifv that was approved, it would change the way we practicee neonatology.” Last month, Discovery Labs’ auditors Ernsft & Young raised concerns abouf the company’s long-term viability, citing its negative cash flow and recurringtoperating losses.