The FDA has finally approved Surfaxin, a preventative treatment for respiratory distress syndrome (RDS) in premature infants. Its maker, Discovery Laboratories, has been working for years (since 2004) with regulators to gain approval for the drug, so the regulatory nod is a hard-earned win for the drug development firm.
Shares of Discovery Labs jumped 35% yesterday upon news of the approval. Many preemie RDS cases are treated with animal-derived surfactants (marketed by companies including Cornerston Therapeutics and Abbott), so Discovery’s synthetic surfactant drug adds a new option for physicians. But while Surfaxin is one of few sanctioned drugs for RDS treatment, the market for premature infants at risk for RDS is relatively small — estimated at about $50 to $70 million.
However, approval of Surfaxin is a good sign for the future of Discovery Labs, which will hopefully be able to gain FDA approval for additional respiratory therapies based on its synthetic surfactant technology. The company has drugs in its pipeline aiming to treat conditions such as cystic fibrosis and acute respiratory failure, as well as additional RDS treatments that could eliminate the cold storage and endotracheal administration requirements for surfactant use.
The regulatory delays on Surfaxin have led the company to conduct layoffs and cost-cutting efforts in recent years, so for the time being, Discovery Labs must focus the majority of its resources on the commercialization of Surfaxin, which is scheduled for late 2012.