Acusphere Inc. to Delay Filing of Heart Drug NDA
The Company also completed a pre-NDA meeting with FDA on Chemistry Manufacturing and Controls (CMC), and plans to incorporate FDA's feedback into the NDA. The Company does not expect this feedback to impact its timeline for filing. However, given the tight timelines for the remaining operational steps to confirm that the manufacturing process is sterile, the Company now believes that the NDA filing date is more likely to occur in early 2008, rather than its previous guidance of year-end 2007.
Dennis J. Bucceri, Senior Vice President, Regulatory, at Acusphere, said, "We are continuing to work diligently with FDA on the elements of the NDA for Imagify. We are confident that we have a clear path forward on the CMC portion of the submission and anticipate continuing our active dialogue with FDA through to the completion of the filing."
Sherri C. Oberg, President and Chief Executive Officer of Acusphere, said, "Completing and filing the Imagify NDA as soon as possible remains our immediate and highest priority so as to start FDA's review and approval of our application as soon as possible. We believe, however, that it is prudent to recognize that this may require more time than was anticipated in our previously communicated timeline. As we proceed with potential partnership discussions for Imagify, we are all focused on the potential multi-billion dollar market that it will enter in the U.S. and elsewhere around the world."
About Acusphere, Inc.
Acusphere (NASDAQ: ACUS - News) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, Imagify(TM) (perflubutane polymer microspheres) injectable suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States. In May 2007 we announced the results of our Phase 3 clinical program for Imagify. We are currently working towards submitting an NDA (New Drug Application) for Imagify. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that over 10 million procedures are done each year in the U.S. to detect coronary artery disease, the leading cause of death in the United States. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site at www.acusphere.com. "Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
Forward-looking Statements
The above press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and likelihood of regulatory approval of an NDA submission for Imagify, the commercial opportunity for Imagify, publication of clinical results, manufacturing qualification and other product development. There can be no assurance that the FDA will accept the Company's NDA for Imagify or that Imagify will be approved for the indication the Company is seeking, or at all. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results and uncertainties regarding the potential affects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, future capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.
Contact: Acusphere, Inc. Conway Communications Mary T. Conway, 617-244-9682 or Investors: 617-925-3444 IR@acusphere.com or Media: 617-648-8800
Source: Acusphere, Inc.