BioCentury
ARTICLE | Clinical News

SkyePharma regulatory update

April 12, 1999 7:00 AM UTC

The FDA granted accelerated marketing approval for SKP's DepoCyt, an injectable sustained-release liposomal formulation of cytarabine to treat lymphomatous meningitis. The drug was developed by SKP subsidiary DepoTech Corp. (San Diego, Calif.). As a result of the approval, shareholders of DepoTech prior to DepoTech's acquisition by SKP will receive 1.06 SKP ADS for every 10 shares of DepoTech common stock fomerly held.

As a condition of the approval, which was based on the surrogate marker of complete response rate, DepoTech must complete clinical testing that demonstrates a clinical benefit resulting from DepoCyt. ...