Acusphere advancing Imagnify, expects new phase 3 data in 2007

By Jennifer Lanning Drey

Portland, Ore., Nov. 8 - Acusphere Inc.'s lead product candidate, Imagnify, is in late-stage phase 3 clinical trials with new data expected in the second quarter of 2007, company chief financial officer John F. Thero said Wednesday.

Thero discussed Imagnify's recent advancements, which include the completion of the first of two pivotal phase 3 clinical trials, at the Cowen and Co. 7th Annual Global Health Care Conference in London.

Imagnify is an ultrasound contrast agent for screening patients with coronary heart disease. Acusphere believes the market for Imagnify in the United States tops $2 billion, Thero said.

The company expects to submit a New Drug Application to the Food and Drug Administration for Imagnify in the second half of 2007.

"We're very excited that we have a lead product that's coming near the end of phase 3," Thero said.

The company plans to retain rights to Imagnify in the United States and already has a $70 million partnership deal in place with Nycomed, which will sell the Imagnify in Europe.

Behind Imagnify, Acusphere also is developing the Hydrophobic Drug Delivery System, which is designed to improve the delivery of drugs that don't dissolve well in water.

The company has studied the technology in a phase 1 clinical trial with Pacltaxel, which showed that the technology was effective.

Acusphere is studying a second drug delivery system, designed to deliver drugs to the lungs, in a phase 1 clinical trial.

Acusphere is a specialty pharmaceutical company based in Watertown, Mass., that develops new drugs and improved formulations of existing drugs using its proprietary microparticle technology.

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