Acusphere says AI-700 phase 3 results coming in second quarter

By E. Janene Geiss

Philadelphia, March 20 - Acusphere, Inc. announced Monday that the 90-day patient follow-up period for one of its phase 3 pivotal trials, the "32" trial for AI-700, has concluded.

The company is now focused on conducting quality control checks to ensure that all of the required data have been fully gathered and filed prior to locking the data base and announcing trial results in the second quarter of 2006, according to a company news release.

The "33" trial will continue to enroll patients into the second quarter of 2006 with results from this trial expected in the fourth quarter this year, officials said.

Since inception of Acusphere's clinical testing of AI-700, more than 1,000 people have received AI-700, including about 750 patients in the phase 3 pivotal trials.

Based upon market research, Acusphere said it believes the potential market for AI-700 expanded in 2005, with an estimated 3 million stress echoes and 8.9 million nuclear stress tests performed in the United States.

Using an assumed $200 price per procedure for AI-700, this represents a potential U.S. market for AI-700 of about $2.4 billion, the company said.

In a further update, build-out of the company's AI-700 manufacturing facility was substantially completed in 2005 and it is now undergoing qualification of AI-700 operations within the facility in compliance with current good manufacturing practices.

The company said it anticipates this process facility will be ready to support a New Drug Application filing for AI-700 in the first half of 2007.

Nycomed, Acusphere's European partner for AI-700, in late 2005 and early 2006, agreed to make payment to Acusphere of up to $2 million earmarked to fund certain activities associated with branding of AI-700 and manufacturing facility qualification, officials said. These payments represent an acceleration of a milestone payment previously due upon acceptance of Nycomed's filing of the Marketing Authorization Approval, the European equivalent of an NDA, for AI-700.

"We have made tremendous clinical and manufacturing progress this year toward the goal of commercializing our lead product candidate, AI-700," Sherri C. Oberg, president and chief executive officer, said in the release.

Acusphere is a Watertown, Mass., specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microparticle technology. Acusphere's three initial product candidates are designed to address large unmet clinical needs within cardiology, oncology and asthma.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.