Healthcare Industry News: paclitaxel
News Release - November 2, 2007
Acusphere to Develop Potential Abraxane(R) BioequivalentReformulation of paclitaxel offers partnership opportunities and faster track to commercialization
WATERTOWN, Mass.--(HSMN NewsFeed)--Acusphere, Inc. (NASDAQ: ACUS ) announced today that its product candidate AI-850 has a comparable pharmocokinetic profile to the breast cancer drug Abraxane® based upon human data available in publications on each drug. AI-850 is Acusphere’s patented formulation of paclitaxel, the active ingredient in Abraxane. Drug product candidates that are confirmed to have equivalent pharmacokinetics in a human study may be eligible for regulatory approval as a bioequivalent, with an accelerated development timeline, since Phase 2 and 3 human clinical trials are usually not required. Abraxane for Injectable Suspension, which is marketed under a co-promotion agreement between Abraxis BioScience, Inc. and AstraZeneca, generated $150 million in revenues in the six months ended June 30, 2007, and is projected by some analysts to reach revenues of $1 billion by 2013.
Acusphere plans to make changes to the AI-850 formulation that will make it a more suitable commercial formulation and plans to work with a partner to bring this improved formulation into development for approval as a bioequivalent to Abraxane. The Company has commenced discussions with potential partners to move this program forward.
Sherri C. Oberg, Acusphere’s President and CEO, said, “Our Hydrophobic Drug Delivery System (HDDS) technology has enabled us to engineer a drug candidate that has comparable pharmacokinetics to one of the fastest growing cancer drugs. We are in active discussions with potential partners on a strategy that could lead to quicker commercialization options for this important program. This program will have no impact on our previously-communicated financial guidance for operating expenses.”
About Acusphere, Inc.
Acusphere 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™ (Perflubutane Polymer Microspheres) for 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 pivotal trials 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.
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 commercial opportunity for AI-850 and Imagify, statements regarding the timing and likelihood of regulatory approval, and the commercial prospects for, each of these product candidates and statements regarding partnership discussions. There can be no assurance that these partnership discussions will result in an agreement.
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 with respect to 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 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.
Abraxane® is a registered trademark of Abraxis BioScience Inc.
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