Discovery Labs ($DSCO) envisions a late 2012 commercial launch in both the U.S. and Europe of its Afectair ventilator drug delivery system, assuming manufacturing timelines stick and European regulators rule as hoped for.
The Warrington, PA-company has billed Afectair as a simplified way to deliver inhaled aerosol medications to critical care patients who require ventilator support. Discovery Labs describes its tech as "a series of proprietary disposable ventilator circuit/patient interface connectors." While the product may not be a blockbuster, the company says it should generate $50 million to $75 million in revenue annually.
The FDA cleared the product for U.S. use, so Discovery Labs is now gearing up its manufacturing plans to make sure it can start selling the product by later this year. The company announced Feb. 8 that it had inked a deal with Lacey Manufacturing to both make and supply Afectair.
In Europe, Discovery Labs said it is seeking a CE mark for the product. Assuming that timeline is on schedule, the company said it believes it will obtain the necessary approval in time to start marketing Afectair by late this year.
Separately, the company has renewed efforts to gain approval for Surfaxin, a treatment for respiratory distress syndrome in infants. The company has been trying to gain approval since 2004, but the FDA has had numerous issues with the drug's stability and release mechanisms. A cash crunch could adversely affect the future for both Afectair and Surfaxin. As of the 2011 third quarter, Discovery reported just $15.4 million in cash on hand, after spending just more than $6 million during the quarter, according to Phillyburbs.com.
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