Epix net loss widens, delays MS-325 NDA

MR contrast agent developer Epix Medical reported second quarter revenues of $3.7 million, up 68% compared with revenues of $2.2 million posted in the second quarter of 2001. For the period (end-June 30), the Cambridge, MA-based firm had a net loss of $6.7 million, compared with a net loss of $5.1 million in the same period last year.

Epix also said it is conducting three additional phase III clinical trials of its MS-325 agent in the aortoiliac, renal and pedal arteries, in a bid to support a broad indication for MR angiography using MS-325 to diagnose peripheral vascular disease. Although overall patient recruitment rate for centers enrolling patients is on track with earlier projections, Epix said that startup of new centers has been slower than anticipated.

As a result, Epix expects patient enrollment will be completed in the first quarter of 2003, which would delay filing of a new drug application (NDA) with the Food and Drug Administration by three to six months. Epix said that partner Schering plans to file for clearance of the agent in Europe shortly after the NDA filing.

By AuntMinnie.com staff writers
July 26, 2002

Related Reading

Epix shows first-quarter loss, April 24, 2002

Epix to raise $30 million, January 16, 2002

Epix revenues climb in Q3, October 19, 2001

Epix, Bracco ink licensing deal, September 25, 2001

Wirth joins Epix Medical board, August 30, 2001

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