Thursday, April 16, 2009

Another promising biotech awaiting FDA approval

With Arena Pharmaceuticals still waiting for recognition of their medicinal and market value, and Dendreon gaining said recognition market cap-wise, we're looking to up our batting average once again with a company seeking FDA approval--after several failed attempts.

Discovery Laboratories, a biotech company, develops proprietary surfactant technology as Surfactant Replacement Therapies (SRT) for respiratory disorders and diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Its products include Surfaxin (lucinactant), which is used for the prevention of respiratory distress syndrome in premature infants, as well as for the prevention of bronchopulmonary dysplasia in premature infants; and Aerosurf, which is used for the prevention and treatment of respiratory failure in infants. The company also provides its products for the treatment of acute respiratory failure, cystic fibrosis, acute lung injury, acute respiratory distress syndrome, chronic obstructive pulmonary disorder, asthma, and other debilitating respiratory conditions.

It addresses a huge market worldwide, and has met FDA guidelines for safety and efficacy, but has had issues of impurity tolerances and producibility. Due to improved technology, we'll see this Friday whether they have cleared those hurdles.

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