Acusphere Presents at Controlled Release Society
The reformulation of clopidogrel bisulfate is an example of the potential for Acusphere's proprietary Hydrophobic Drug Delivery System (HDDS(TM)) technology to create intravenous formulations of drugs that are currently only available in oral dosage form. In a hospital setting, intravenous formulations can be desirable because rapid onset of action is especially important in acute situations, and many patients are unable to take oral medications. Many drugs are hydrophobic and only available in oral dosage form, and some have generated revenue of over $1 billion in annual worldwide revenues, such as Biaxin(R), Celebrex(R), Coreg(R), Norvasc(R) and Plavix(R). The Company has demonstrated, in multiple laboratory tests that its technology has the potential to enable the intravenous formulation of drugs currently available only in oral form in a wide variety of drug classes, including antibiotics, non-steroidal anti-inflammatory drugs, anti-platelets and anti-hypertensives. Some of these new formulations, if commercialized, could potentially fit into the acute care commercial infrastructure that the Company is developing to support its lead product candidate, Imagify(TM) (perflubutane polymer microspheres) injectable suspension. Acusphere plans to announce such a new development program later this quarter.
"Clopidogrel bisulfate is a particularly challenging drug to formulate for intravenous delivery because it is not only hydrophobic but it is also an oil under conditions appropriate for administration," stated Howard Bernstein, M.D., Ph.D., Acusphere's Executive Vice President of Research and Development. "These findings further demonstrate the breadth of our proprietary technology's ability to create intravenous formulations of even the most difficult to formulate drugs."
About Acusphere, Inc.
Acusphere (NASDAQ: ACUS) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. The Company is 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. Its 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 the Company announced the results of its Phase 3 clinical program for Imagify. It is 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. The Company estimates that the potential annual U.S. market opportunity for Imagify exceeds $2 billion. 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.
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 concerning the technical capabilities of the Company's microparticle technology and the commercial prospects for the same, the Company's intention of commencing and announcing a new development program for this technology later this year, the timing and ability of the Company to file an NDA for its lead product Imagify and the ability of the Company to successfully commercialize Imagify and develop an infrastructure to support such commercialization. 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 and development, especially those involving new and untested technologies, uncertainties associated with regulatory approvals, especially uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results for Imagify 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 March 31, 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.
Stephen Schultz, 617-648-8800
Director, Corporate Communications
Posted: July 2007