Healthcare Industry News: nanoparticles
News Release - September 20, 2006
Acusphere Hires Jonathan Jaffe, M.D. in Newly Created Position of Vice President Medical AffairsCommercial Preparations Also Include Naming of Product Candidate
WATERTOWN, Mass.--(HSMN NewsFeed)--Sept. 20, 2006--Acusphere, Inc. (NASDAQ: ACUS ) today announced that the Company has taken additional important steps in preparation for commercialization of its lead product candidate, AI-700, an ultrasound contrast agent for early detection of coronary heart disease. Jonathan Jaffe, M.D. joined the Company as Vice President, Medical Affairs, bringing to Acusphere 30 years of experience focused on cardiology and cardiovascular disorders. Dr. Jaffe has overall responsibility at Acusphere for medical affairs, including the relationship between Acusphere and the medical/scientific community. He also will be relied upon for input on commercial initiatives and various strategic matters.
Dr. Jaffe is a board certified cardiologist and prior to joining Acusphere, directed the Merck National Science Cardiovascular/ Endocrine/ Metabolic and Obesity team. In this capacity, Dr. Jaffe's team was focused on connecting Merck with the scientific and academic communities to establish valuable working relationships. In addition to his experience at Merck, Dr. Jaffe has extensive professional experience in clinical research and the prevention, early detection and treatment of cardiovascular disorders. His private sector medical experience was focused on practicing preventive cardiology and includes extensive background in echocardiography and vascular imaging.
"I am pleased to join the Acusphere team as we near the completion of the AI-700 clinical trials process at a time when cardiac disorders are growing at rapid rates," said Dr. Jaffe. "Early detection of cardiovascular disease using a safe and convenient method is fundamental to our promise, as physicians, to providing quality and timely healthcare affordably."
Acusphere also announced that AI-700 has been given the brand name of Imagify(TM) (Perflubutane Polymer Microspheres) Injectable Suspension, pronounced i-maj'-i-fi. Creating a brand name for this product candidate reflects the Company's ongoing preparations for commercialization of this product. The name includes input from the Company's European partner, Nycomed, and is intended to be used worldwide.
In making this announcement, Sherri Oberg, Acusphere's President and CEO stated, "We are delighted to have Dr. Jaffe join our team. His stature and experience will be very helpful as we complete our Phase 3 trials, work with FDA on the NDA (New Drug Application) review process and prepare to launch Imagify. His unique combination of industry, clinical and real-world experience should provide a very good complement to our existing clinical team both for Imagify and for other potential products that we are considering developing."
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 are designed to address large unmet clinical needs within cardiology, oncology and asthma. These product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microparticles in a versatile manner that allows particles to be customized to address the delivery needs of a variety of drugs. Acusphere's lead product candidate, Imagify (formerly known as AI-700), is a cardiovascular drug in Phase 3 clinical development. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary heart disease. An estimated 11.9 million procedures are done each year in the U.S. to detect coronary heart disease, the leading cause of death in the United States. For more information about Acusphere visit the Company's web site at www.acusphere.com. "Acusphere" is a trademark of Acusphere, Inc.
The above press release contains forward-looking statements regarding the application of Acusphere's proprietary microparticle technology which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that statements in this press release, including statements relating to the commercialization of Imagify and development of other products constitute forward-looking statements which involve risks and uncertainties. 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 the ultimate outcome of Acusphere's Phase 3 clinical trials for Imagify and uncertainties regarding the number of patients required to complete the Phase 3 clinical trials, unproven markets, future capital needs and uncertainty of additional financing, lack of sales and marketing experience, 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, competition, uncertainties associated with intellectual property, 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, 2006. 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.
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