More than a year after receiving regulatory approval for its first drug, Discovery Laboratories Inc. still has not launched Surfaxin, a treatment to prevent a respiratory illness that affects premature infants.
The Warrington biotechnology firm now says it expects to begin selling Surfaxin to hospitals during the second quarter after delaying the launch last October. The company said the delay was related to one of the analytical chemistry methods used to assess how the synthetic drug conforms to its product specifications.
The only hurdle now is obtaining confirmation from the Food & Drug Administration for the updated product specifications, according to the company.
During a conference call with securities analysts, Discovery Labs reiterated its sales expectations for Surfaxin of $8 million to $10 million for the first 12 months and about $40 million for the fourth year.
Discovery Labs continued to lose money in 2012 with its net loss for the full year increasing to $37.3 million, or 95 cents per share, from $21.0 million, or 93 cents per share, in 2011. The company ended the year with $26.9 million in cash on its balance sheet.
Shares closed down 6.6 percent, or 17 cents per share, to $2.42 Wednesday. Shares are down 35 percent since the FDA approved Surfaxin.