Healthcare Industry News: nanoparticles
News Release - February 5, 2007
Acusphere Hires Dennis Bucceri to Head Regulatory AffairsIndustry Veteran to Lead Regulatory Process for Imagify(TM) and Other Product Candidates
WATERTOWN, Mass.--(HSMN NewsFeed)--Acusphere, Inc. (NASDAQ: ACUS ) today announced the Company has hired Dennis Bucceri as Senior Vice President of Regulatory Affairs. This addition is made as the Company prepares for the regulatory evaluation stage of its lead product candidate, Imagify, a cardiovascular drug for screening of coronary artery disease, and evaluates development of other potential product candidates. Mr. Bucceri brings to Acusphere a wealth of experience and leadership in support of regulatory affairs. He has been responsible for submitting and securing approval of over 35 NDA's (new drug applications) during his career.
Mr. Bucceri comes to Acusphere from Genzyme Corporation where he was Vice President in charge of Regulatory Affairs for the Therapeutics Group for six years. His responsibilities covered broad regulatory supervision of submissions, manufacturing, marketing and drug registration. Prior to Genzyme, Mr. Bucceri served at Hoechst-Roussel for 20 years in roles of increasing responsibility including Vice President, Regulatory Affairs. He subsequently held senior-level regulatory roles at Serono Laboratories and Astra, USA. Mr. Bucceri began his career as a Commissioned Officer at the U.S. Food and Drug Administration (FDA).
In welcoming Bucceri to the Company, Acusphere President and CEO Sherri C. Oberg stated, "Dennis brings a great understanding of the regulatory process and further strengthens our regulatory experience as we prepare to move Imagify from clinical to regulatory evaluation. His proven track record provides me with added confidence that we will be prepared for our planned NDA submission for Imagify. In addition, his breadth of experience will strengthen our ability to evaluate drug product candidates for expansion of our product pipeline. "
The Company also announced that Nancy Wetherbee, who was formerly Senior Vice President of Business Development, is no longer with the Company.
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, 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 ability for Imagify to be approved for commercial use and the 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 September 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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