Warrington, Pa., Biotech Company Develops Aerosol Medicines
By Linda Loyd, The Philadelphia Inquirer
Dec. 13–A division of the nation’s largest tobacco company is teaming up with a Philadelphia-area biotechnology company to develop aerosol medicines for a variety of respiratory diseases.
Discovery Laboratories Inc., in Warrington, said yesterday it has formed a strategic alliance with Chrysalis Technologies, a unit of the No. 1 U.S. cigarette maker Philip Morris USA, to design and sell aerosolized surfactant replacement therapies to treat serious respiratory conditions, such as asthma, cystic fibrosis, acute lung injury, and breathing problems in premature infants.
Richmond, Va.-based Chrysalis Technologies, a wholly owned subsidiary of the maker of Marlboro and Virginia Slims cigarettes, has an aerosolization device technology that enables the delivery of medicines deep into the lungs.
Robert J. Capetola, president and chief executive officer of Discovery Labs, acknowledged “it is ironic” that the technology originated with a tobacco business. “But the science was there, and the science is what drove the decision,” he said, in an interview.
Discovery Labs is a maker of surfactant replacement therapies, which mimic human lung surfactants that are produced naturally in healthy lungs and are essential for breathing.
The Bucks County company evaluated technologies around the world for the “best-suited to deliver the highest qualities of pulmonary surfactant to the lungs of little babies,” Capetola said. “As it turns out, Chrysalis came out ahead of everyone else.”
Under the deal, Discovery Labs will have exclusive rights to Chrysalis’ aerosolization technology for use with pulmonary surfactants. Discovery will be responsible for all manufacturing, regulatory, clinical, sales and marketing efforts, Capetola told investors on a conference call.
Philip Morris USA’s Chrysalis will receive tiered royalties based on Discovery’s sales of products developed by the alliance. In turn, Chrysalis will pay for and manage the engineering of the aerosol delivery systems.
The technology could enable doctors to treat infants without inserting a breathing tube down the trachea, Capetola said. “It’s one of the most exciting developments we have in our pipeline,” he said. The companies plan to begin mid-stage Phase 2 clinical trials next year.
Chrysalis Technologies’ Web site said the company was seeking pharmaceutical and biotech partners for its aerosol inhaler “to enable or enhance pulmonary drug delivery.”
Altria Group Inc.’s Philip Morris USA said in a statement that “while not part of our tobacco or tobacco-related adjacency growth strategy, this alliance offers us the opportunity to develop our aerosol generation technology with a new class of pulmonary medicine products” at a time tobacco sales have been declining.
In 2004, the percentage of U.S. adult smokers was 20.9 percent, down from 21.6 percent a year earlier, according to the American Lung Association. At the same time, consumption dropped from 400 billion cigarettes in 2003 to 388 billion cigarettes last year, the group said.
Discovery Labs’ lead product, Surfaxin, has received an “approvable” letter from the Food and Drug Administration for the prevention of respiratory distress syndrome in premature infants.
In August, federal regulators asked for more information on its Surfaxin lung drug for premature infants. The company expects a final decision from the FDA in April.
As a development stage company, Discovery Labs reported a loss of $10.4 million for the third quarter and $29.5 million for the nine months ended Sept. 30.
Shares of Discovery Labs closed up 7 cents to $7.20 on the Nasdaq Stock Market. Shares of Altria Group, which owns 86.5 percent of Kraft Foods Inc., closed up 30 cents to $72.51 on the New York Stock Exchange.
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