MR contrast developer Epix Pharmaceuticals of Cambridge, MA, has been hit with a class-action lawsuit related to a recent approvable letter the company received for its lead product in development, MS-325.
The suit was filed by Lerach Coughlin Stoia Geller Rudman & Robbins in the U.S. District Court for the District of Massachusetts. The complaint alleges that, by the start of July 10, 2003, Epix had become aware of clinical quality issues with the underlying data for phase III clinical trials for MS-325. The suit alleges that these issues, including the generation of unintelligible imaging scans, made difficult, if not impossible, the proper control of Epix's clinical test results and statistical analysis of the data and results.
On January 14 this year, Epix reported that the U.S. Food and Drug Administration requested additional clinical studies to demonstrate efficacy, prior to approval, of the MS-325 contrast agent. Epix said that the agency's principal questions related to the noncontrast MRA comparator scans used in the phase III trials, and to the statistical treatment of uninterpretable images.
The law firm said that it seeks to recover damages on behalf of all purchasers of Epix securities between July 10, 2003, and January 14, 2005.
By AuntMinnie.com staff writers
January 28, 2005
Related Reading
Epix gets approvable letter, January 14, 2005
Epix shows Q3 downturn, October 27, 2004
Epix Medical changes name, September 8, 2004
Epix begins testing blood clot imaging agent, August 6, 2004
Epix names Uprichard president and COO, July 16, 2004
Copyright © 2005 AuntMinnie.com
