Surfactants in the News Again, FDA grants orphan status to Chiesi Pharma in the wake of Discovery Lab's Approval - $DSCO

According to the FDA's Orphan Drug product website, Chiesi Pharmaceuticals (an Italian-private pharma company) has been granted Orphan drug designation for 'Synthetic Surfactant Comprised Of Dppc, Popg Na, Synthetic Sp-C Analogue And Synthetic Sp-B Analogue' for the treatment of preterm neonatal respiratory distress syndrome (RDS). Recall that the FDA recently approved Discover Labs ($DSCO) synthetic surfactant too (aka: Surfaxin).

Chiesi currently has an approved animal-sourced product for neonatal RDS, Curosurf; this new orphan designation is specifically for a synthetic drug candidate.  The companies previously approved products include Curosurf  (all are animal-sourced products).  In the US, Cornerstone Therapeutics ($CRTX) has  marketing rights.

Discovery Laboratories ($DSCO): Raises $45 million

Discovery Laboratories Inc. (NASDAQ:DSCO) completed the raise at $45 million through the sale of 16 million shares at $2.80. Lazard; Stifel Nicolaus Weisel; and Roth Capital Partners were the selected banks. Discovery Laboratories proposed the offering late Thursday, when its share price was $3.50. Discovery Laboratories was off $0.65 (19%) to $2.85 on Friday.

Earlier this month, FDA approved the company's Surfaxin (a synthetic drug) designed to replace the animal surfactants that are used to to prevent respiratory distress syndrome (RDS) in premature infants. The company plans to launch the humanized lung surfactant in the U.S. late this year.  See our prior comment, "4th Time is a Charm".

Discovery Labs ($DSCO): No Hesitation, Discovery Is Raising Dollars in the wake of Good FDA News

Discovery Labs ($DSCO) announces proposed public offering of undetermined amounce of common stock through Lazard.

Lazard Capital Markets LLC is acting as the sole book-running manager for the offering, Stifel Nicolaus Weisel is acting as co-lead manager, and ROTH Capital Partners, LLC is acting as co-manager , see ournote from earlier in the week regarding Surfaxin, 4th times a charm.

Discovery Labs ($DSCO): Fourth time's a charm !

Discovery Laboratories (DSCO) gains on Surfaxin approval : Discovery Laboratories Inc. (NASDAQ: DSCO) gained as much as 44% yesterday (Wednesday) before closing up 9%, or $0.33, to $4.08 after FDA approved Surfaxin lucinactant late Tuesday to prevent respiratory distress syndrome in premature infants. Discovery plans to launch the humanized lung surfactant in the U.S. late this year. We can't recall if this is the fourth or fifth time that Surfaxin went up for approval but Kudos to the DSCO team for hanging in there to get it done.

Conclusion: Discovery (DSCO) is worth watching now. While this is a niche product, there is a real market opportunity in prematurely born infants and we believe with the great need that specialty and big pharma has DSCO could be acquired at a premium, so we would be inclined to own shares and see what happens.

Flash Player 9 or higher is required to view the chart
Click here to download Flash Player now

View the full DSCO chart at Wikinvest