Discovery Laboratories, Inc.
) portfolio consists of Surfaxin, an intratracheal suspension for
the prevention of respiratory distress syndrome (RDS) in
premature infants who are at high risk of the disease.
The U.S. Food and Drug Administration (FDA) had approved the drug
in Mar 2012. Discovery Labs had then planned to launch Surfaxin
in late 2012. However, in the third quarter of 2012, the company
delayed the launch of Surfaxin based on a review of an analytical
testing and quality control process of the drug. It was found
that an improvement was required in one of the analytical
chemistry methods used to assess Surfaxin and an update to
product specifications related to Surfaxin was warranted.
Consequently, Discovery Labs submitted updated product
specifications to the FDA after improving and revalidating the
analytical chemistry method. In Apr 2013, the FDA requested
clarification related to updated product specifications for
Surfaxin. The company submitted its response in Jun 2013. In Oct
2013, the FDA approved the product specifications update related
to Surfaxin. The company expects to launch the drug in the fourth
quarter of 2013.
Meanwhile, Discovery Labs expects to initiate a phase II program
on another RDS candidate, Aerosurf, by year end. The company has
submitted an investigational new drug (IND) application to the
FDA for Aerosurf.
) Survanta is approved for the prevention and treatment of RDS in
Discovery Labs currently carries a Zacks Rank #4 (Sell). At
present, companies like
) look attractive with a Zacks Rank #1 (Strong Buy).
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