Thursday, December 11, 2008

Acusphere’s Imagify rejected by FDA committee

By Mass High Tech staff

One day after the Nasdaq Global Market temporarily stopped trading of Acusphere Inc. common stock, the company’s heart imaging agent, Imagify for Injectable Suspension, was rejected by the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee. The FDA cited concerns that the risks of the product outweigh the benefits of its diagnostic capabilities for detecting coronary artery disease, Acusphere (Nasdaq: ACUS) officials said.

The rejection from the FDA committee advisories does not necessarily translate to a rejection by the FDA itself in evaluating Imagify for its New Drug Application.

Imagify is an investigational injectable imaging drug that uses ultrasound to diagnose coronary artery disease. The ultrasound technique would provide an alternative to standard nuclear stress testing, company officials reported.

Watertown-based Acusphere has battled a tough year with multiple Nasdaq delisting warnings and layoffs of 24 employees, about a quarter of its staff, in July. The staff cuts are in the company’s manufacturing group responsible for making Imagify. In October, the company announced a $20 million debt offering agreement with biopharmaceutical firm Cephalon Inc. At the time, Acusphere CEO and president Sherri C. Oberg said in a statement that the agreement would help finance the FDA approval process of Imagify.

In September, Acusphere reported a quarterly net loss of $10.3 million on quarterly revenue of $340,000.