Acusphere Takes Occupancy of Commercial Manufacturing Facility in Tewksbury, Massachusetts.WATERTOWN, Mass. -- Acusphere, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ACUS acus (a´kus) a needle or needle-like process. acus a needle or needle-like process. ), a specialty pharmaceutical company that develops drugs using its porous microparticle technology, announced today that it has taken occupancy of its commercial manufacturing facility in Tewksbury, Massachusetts Tewksbury (pronounced IPA: /ˈtʊksbɛriː, ˈtʊksbriː/) is a town in Middlesex County, Massachusetts, United States. The population was 28,851 at the 2000 census. . Over the past year, Acusphere has been converting an existing pharmaceutical manufacturing facility within 25 miles of the Company's Watertown, Massachusetts The Town of Watertown is a city[1] in Middlesex County, Massachusetts, United States. The population was 32,986 at the 2000 census. History Watertown, first known as Saltonstall Plantation, was one of the earliest of the Massachusetts Bay settlements. headquarters to manufacture its lead product candidate. Engineering, design and construction of this facility began under a contract entered into in November 2004. Acusphere recently received an occupancy permit for this built-out facility. The Company is now focusing on the next stage of the project: the start-up and qualification of AI-700 operations within the facility, in accordance with current good manufacturing practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. (cGMPs). "We are very pleased with the progress we have made in constructing a facility designed for AI-700," commented Sherri C. Oberg, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Acusphere. "We believe that this facility will provide us with the commercial scale production capability necessary to effectively launch AI-700 throughout the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and, through partners, worldwide." An estimated 10.7 million procedures in the U.S. and more than 1.0 million procedures in Europe are performed each year to screen patients with suspected coronary heart disease coronary heart disease: see coronary artery disease. coronary heart disease or ischemic heart disease Progressive reduction of blood supply to the heart muscle due to narrowing or blocking of a coronary artery (see atherosclerosis). , primarily using nuclear imaging. AI-700-enhanced ultrasound is being developed as a cost-effective and convenient alternative to nuclear imaging. About Acusphere, Inc. Acusphere (NASDAQ: ACUS) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microparticle technology. Acusphere's three initial product candidates for which it has clinical data are designed to address unmet clinical needs within cardiology cardiology Medical specialty dealing with heart diseases and disorders. It began with the 1749 publication by Jean Baptiste de Sénac of contemporary knowledge of the heart. Diagnostic methods improved in the 19th century, and in 1905 the electrocardiograph was invented. , oncology and asthma. Acusphere's lead product candidate, AI-700, is a cardiovascular drug in Phase 3 clinical development. An estimated 10.7 million procedures are performed each year in the U.S. to detect coronary heart disease, the leading cause of death in the United States. Acusphere's product candidates have been created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microparticles in a versatile manner that enables particles 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" is a trademark of Acusphere, Inc. Forward-looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. This Release contains forward-looking statements, including statements regarding the qualification and capacity of its manufacturing facility and the effective commercial launch of AI-700. The Company's actual results and trading in shares of the Company's stock may differ materially from that anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding the ultimate outcome of Acusphere's Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. for AI-700, unproven markets, future capital needs and uncertainty of additional financing, competition, uncertainties associated with intellectual property, complex manufacturing, high quality requirements, dependence on third-party manufacturers, suppliers and collaborators, loss of key personnel, lack of sales and marketing experience, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other potential risks and challenges. Further details regarding potential risks and challenges are detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended June 30, 2005. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this 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 Release or to reflect the occurrence of unanticipated events. |
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