Acusphere, Incorporated
News and Blogs

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Acusphere Receives Letter from NASDAQ Citing Failure to Regain Compliance with Minimum Bid Price Rules (Business Wire)
biz.yahoo.com | Jul 15, 2008
Acusphere Receives Letter from NASDAQ Citing Failure to Regain Compliance with Minimum Bid Price Rules. - WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (NASDAQ: ACUS - News) announced today that on July 14, 2008, it received a letter from The NASDAQ Stock Market LLC indicating that the Company
Analyst Comments: Votorantim Celulose, SCOR Group, Acusphere, Eagle Test Systems
www.istockanalyst.com | Jun 30, 2008
We are keeping our Hold recommendation on Brazilian pulp-producer Votorantim Celulose e Papel S.A. (VCP). Demand for pulp and paper remains heated in Brazil and abroad, especially in Asia, which is keeping prices elevated. Guidance for the second quarter of 2008 was positive, and the short-term
http://www.istockanalyst.com/article/viewarticle+articleid_2350567.html
Acusphere seeks FDA approval for imaging agent (at bizjournals.com)
boston.bizjournals.com | Apr 29, 2008
The Watertown, Mass.-based company (Nasdaq: ACUS) said on Tuesday that it had submitted a new drug application to the U.S. Food and Drug Administration for its lead product Imagify.
http://boston.bizjournals.com/boston/stories/2008/04/28/daily15.html?ana=yfcpc
Acusphere files new drug application for Imagify
www.pharmaceutical-business-review.com | Apr 29, 2008
Acusphere has submitted a new drug application to the FDA for approval to market its lead product candidate, Imagify.
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ACUSPHERE, INC.
Watertown, MA, July 2, 2002 Acusphere, Inc. announced today the issuance of U.S. Patent No. 6,395,300, entitled "Porous Drug Matrices and Methods of Manufacture Thereof.
Acusphere to bring in $23.8M from stock deals - Mass High Tech: The Journal of New England
www.bizjournals.com
The Watertown-based plans to sell 9.3 million units to institutional investors, say executives. Each unit will cost $2.75 and consist of one share of common stock and a warrant to purchase 0.4 shares of stock between June 12, 2007 and Dec. 12, 2011 at a price of $3.11 per share.
http://www.bizjournals.com/masshightech/stories/2006/12/04/daily27.html?from_rss=1
Acusphere Drug-Delivery Company Profile (market briefing)
Acusphere Inc is a specialty pharmaceutical company that develops improved formulations of existing drugs and drug-delivery systems using its proprietary porous microparticle drug-delivery technology.
News from Zibb.com
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Acusphere, Inc. Reports Q1 2008 Financial Results and Business Highlights - Zibb.com
WATERTOWN, Mass., May 08, 2008 (BUSINESS WIRE) --
Acusphere, Inc. (NASDAQ: ACUS) today reported financial results for the first quarter ended March 31, 2008 and commented on its financial results and business highlights.
Following the end of the quarter, Acusphere submitted its first New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA) for its lead product candidate, Imagify(TM) (Perflubutane Polymer Microspheres) for Injectable Suspension. Imagify is a Perfusion Stress Echo imaging agent for use in detecting coronary artery disease.
Major Accomplishments in Q108
-- Licensed Hydrophobic Drug Delivery System (HDDS) technology for oncology applications to Cephalon Inc. for $10 million
-- Completed aseptic validation process at its Tewksbury, Massachusetts manufacturing facility
-- Secured stockholder approval of authorization to implement a reverse stock split of the Company's common stock if necessary; thus far, the Board of Directors has determined not to effect the split
Business Priorities
Acusphere's key current priorities are:
-- Moving ahead with facilities preparation and other aspects of the regulatory review of Imagify
-- Continuing potential partnership and financing discussions for Imagify
The Company continues to support the Marketing Authorization Application (MAA) submission in Europe by Nycomed, its European partner, which is planned for the second half of 2008. Process validation efforts are continuing at the Tewksbury facility, along with preparations for the FDA's pre-approval inspection, which could occur by early 2009.
Acusphere continues to be actively engaged in the previously-announced wide-ranging partnership discussions regarding Imagify. In addition, the Company continues to explore other financing alternatives. With the Company's entire focus on Imagify and the preparations for the NDA submission in 2008, operating expenses during the first quarter this year were up slightly compared to both the year ago period and the immediately preceding quarter. Total cash used by the Company in the first quarter, however, exclusive of the $10 million licensing fee, declined $11.4 million compared to a decline of $13.4 million in the immediately preceding quarter.
Sherri C. Oberg, President and CEO of Acusphere, said, "We are very pleased with our accomplishments thus far this year, especially with the recent submission of the NDA for Imagify. This is a pivotal achievement for our company, and we look forward to an on-going dialogue with FDA as part of the review process."
She added, "At the same time, we are continuing to work diligently on potential financing and strategic partnership discussions, and were pleased with our recent licensing deal with Cephalon for our HDDS technology."
Financial Results
The Company's financial results for the quarter ended March 31, 2008, are summarized in the accompanying table and detailed in Acusphere's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission today.
The Company recognized $0.7 million in collaboration revenue during the first quarter of 2008. These revenues were recognized in connection with its agreement with Nycomed for European marketing rights for the Company's lead product candidate, Imagify. As of March 31, 2008, the Company had $14.0 million in deferred revenue.
Operating expenses for the first quarter of 2008 were $13.9 million, versus $13.2 million in the prior year period. R&D expense increased $0.7 million to $10.7 million, reflecting the expensing of an IP-related milestone payment payable in the second quarter triggered by Acusphere's submission of the Imagify NDA in April. General and administrative expenses, at $3.2 million in the first quarter of 2008, were basically flat with the prior year period. Operating expenses include non-cash charges of $2.9 million in the first quarter of 2008 and $3.2 million in the first quarter of 2007, for depreciation, amortization and stock options.
The net loss after dividends for the first quarter of 2008 was $14.0 million, or $0.30 per common share, versus a net loss of $13.1 million, or $0.34 per common share, in the prior year period.
As of March 31, 2008, the Company's balance sheet included approximately $48.0 million in total assets, comprised primarily of $24.7 million in cash and short-term investments and $20.8 million in property and equipment, net of accumulated depreciation.
The Company is today revising downward its previous guidance for 2008 quarterly cash utilization to $9-$13 million per quarter with the low end of the range being more reflective of the latter part of the year. Previously, the Company had anticipated quarterly cash expenditures of $11-14 million this year. The submission of the NDA and completion of many of the activities required to support the review of the NDA now warrant the lower guidance. Based upon these projections, and the current cash position, the Company anticipates the need for additional sources of funds to operate beyond the third quarter of 2008.
Conference Call Information
Acusphere plans to hold a conference call with investors today, Thursday, May 8, 2008, commencing at 4:30 PM (Eastern Time). The conference call will cover the Company's financial results, operating results and business outlook and will be led by Sherri C. Oberg, President and Chief Executive Officer and Lawrence A. Gyenes, Senior Vice President and Chief Financial Officer. These Acusphere representatives will also be available for investor questions. The conference may be heard live via the investor relations section of the Company's website at www.acusphere.com or by dialing 1-800-299-6183, or internationally 1-617-801-9713, using the confirmation code: 74094918. After the conference call, a replay of the call webcast will be made available via the Company's web site and a telephone replay will be available through June 8, 2008 by dialing 1-888-286-8010, or internationally 1-617-801-6888, using the confirmation code: 36266537.
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. 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(TM) (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, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008. 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 more than 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.
Glossary of Terms:
MAA: Marketing Authorization Application seeking European regulatory approval to market and sell a new drug such as Imagify.
NDA: New Drug Application seeking U.S. regulatory approval to market and sell a new drug such as Imagify.
HDDS: Hydrophobic Drug Delivery System is Acusphere's patented technology designed to allow intravenous delivery of many drugs that are not easily soluble in water.
Forward-looking Statements
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 Company's financial guidance for 2008, the efficacy, safety and tolerability of Imagify, the NDA and MAA submission for Imagify and likelihood of regulatory approval, the commercial opportunity for Imagify, manufacturing qualification, the commercial opportunity for other product candidate and other business development efforts, including partnership discussions. There can be no assurance that regulatory authorities will accept the Company's NDA or MAA for Imagify or that Imagify will be approved for the indication the Company is seeking, or at all. There can be no assurance that partnership discussions will result in an agreement. The Company's Q1 2008 interim financial statements, as discussed in this release, are preliminary and unaudited, and subject to adjustment. 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 and uncertainties regarding the potential effects 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 Annual Report on Form 10-K for the year ended December 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.
ACUSPHERE, INC.
FINANCIAL HIGHLIGHTS
-- In Thousands (except per share data) --
CONDENSED CONSOLIDATED OPERATING RESULTS
(Unaudited)
Three Months Ended
---------------------
March 31, March 31,
2008 2007
Revenue $ 667 $ 667
Operating expenses:
Research and development 10,741 9,988
General and administrative 3,171 3,220
---------- ----------
Total operating expenses 13,912 13,208
Interest and other income (expense) (237) 186
Change in valuation of derivative - (160)
---------- ----------
Net loss ($13,482) ($12,515)
Dividends on preferred stock (528) (593)
---------- ----------
Net loss available to common stockholders ($14,010) ($13,108)
Net loss per common share - basic and diluted ($0. 30) ($0.34)
Weighted-average shares outstanding - basic and
diluted 46,503 38,111
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
(Unaudited)
----------------------
March 31, December 31,
2008 2007
--------- ------------
Cash and short-term investments $24,729 $26,102
Current assets 25,873 27,367
Total assets 48,010 52,020
Current portion of long-term obligations 9,664 8,556
Other current liabilities, less current
deferred revenue 7,026 5,603
Deferred revenue, current and long-term 14,000 4,667
Long-term liabilities, net of current portion 7,146 9,454
Stockholders' equity 10,174 23,740
SOURCE: Acusphere, Inc.
Conway Communications Mary T. Conway, 617-244-9682 or Acusphere, Inc. Investors: 617-925-3444 IR@acusphere.com or Media: 617-648-8800
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Companies: Acusphere Inc (ACUS)
Acusphere Announces FDA Acceptance of Imagify(TM) NDA for Detection of Coronary Artery Disease -
WATERTOWN, Mass., Jun 30, 2008 (BUSINESS WIRE) --
Acusphere, Inc. (NASDAQ: ACUS) announced today that the New Drug Application (NDA) for approval to market its lead product candidate, Imagify(TM) (Perflubutane Polymer Microspheres for Injectable Suspension), has been accepted for review by the U.S. Food & Drug Administration (FDA). Imagify is an ultrasound imaging agent for the detection of coronary artery disease, the leading cause of death in the United States. The NDA includes data from studies of Imagify in more than 1,000 patients worldwide, including two pivotal international multi-center Phase III clinical trials, RAMP-1 and RAMP-2 (Real-Time Assessment of Myocardial Perfusion).
Imagify is the first ultrasound imaging agent designed to assess blood flow in the heart (myocardial perfusion), a sensitive marker of coronary artery disease. The Company believes it is also the first ultrasound imaging agent to demonstrate in large clinical trials clinically equivalent accuracy to nuclear stress testing, the current standard for assessing myocardial perfusion. Currently, perfusion information is not available using cardiac ultrasound, but must be obtained using a nuclear stress test, an expensive and time-consuming test that involves injecting the patient with a radioactive imaging agent. More than 10 million stress imaging procedures are done each year in the U.S. to detect coronary artery disease.
Sherri C. Oberg, Acusphere's President and Chief Executive Officer, said, "We are very pleased that FDA has decided to accept our NDA submission for Imagify. In our view, Imagify could enable great strides forward in the detection of heart disease, with such important benefits as lower costs, speedier results and greater accessibility without exposure to radiation. We at Acusphere are eager to see those benefits brought to the aid of millions of patients and doctors in the U.S."
The FDA acceptance of the NDA submission indicates that the application is sufficiently complete to permit a substantive review and meets the threshold for filing. With a standard review, under the FDA Prescription Drug User Fee Act (PDUFA), the target action date is 10 months from the submission date, or February 28, 2009.
About Imagify(TM)
Imagify(TM) is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease. Myocardial perfusion is blood flow in the heart muscle and is a sensitive marker of coronary artery disease. Currently, perfusion information is not available using cardiac ultrasound but must be obtained using a nuclear stress test, which is the most frequently used imaging procedure for detecting coronary artery disease. Imagify is designed to provide real-time perfusion information with quicker results, lower cost, broader access and no exposure to radiation compared with nuclear stress tests. Imagify was designed to be used with commercially available ultrasound equipment and established imaging techniques. In the RAMP-1 and -2 trials, Imagify was well-tolerated with the majority of adverse effects (AEs) reported being mild in intensity, transient, and resolved without residual effects. The most common AEs (>4%) reported were headache, chest pain or discomfort, nausea, flushing, leukocytosis, feeling hot and dizziness and occurred following dipyridamole dosing (an alternative to exercise stress) and required no treatment.
About CAD
According to the American Heart Association, approximately 16 million people in the United States suffer from coronary artery disease (CAD), the single leading cause of death in the United States. CAD is characterized by the accumulation of plaque, which narrows coronary arteries and reduces blood flow in the heart muscle. The reduced blood flow can cause chest pain, and if the plaque ruptures, it may cause a heart attack. The American Heart Association estimates that the direct and indirect cost of CAD in the United States for 2007 was more than $150 billion. Early detection of CAD can save lives, reduce treatment costs and improve patients' quality of life. Two of the most common methods of CAD screening are nuclear stress imaging and stress echocardiography, or "stress echo"--ultrasound of the heart. In 2006, more than 10 million of these screening procedures were performed in the United States, including more than seven million nuclear stress tests and nearly three million stress echo procedures.
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(TM) (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. 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 safety and efficacy of and commercial opportunity for Imagify. There can be no assurance 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 and uncertainties regarding the potential effects of not achieving clinical endpoints, 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 Annual Report on Form 10-K for the year ended December 31, 2007 and its 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.
SOURCE: Acusphere, Inc.
Conway Communications Jane W. McCahon, 978-443-0160 or Acusphere, Inc. Investors: 617-925-3444 IR@acusphere.com or Media: 617-648-8800
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Companies: Acusphere Inc (ACUS)
Acusphere, Inc. Reschedules IP Payments - Zibb.com
WATERTOWN, Mass., May 20, 2008 (BUSINESS WIRE) --
Acusphere, Inc. (NASDAQ: ACUS) today announced that it had completed the renegotiation of payment terms under certain intellectual property agreements. Payments due in the 12 months ending March 31, 2009 have been reduced by $3.5 million and shifted out by the same amount to later in 2009. The Company expects a full response letter from the FDA on its recently filed NDA for Imagify(TM) (Perflubutane Polymer Microspheres) for Injectable Suspension, on or around the PDUFA date in Q1 2009.
Lawrence A. Gyenes, Chief Financial Officer of Acusphere, said, "We are very pleased to reach these agreements. They allow us to conserve cash, as we continue to work diligently on a range of potential strategic partnership and financing alternatives to fund our on-going business operations."
Under the revised payment terms, the Company now expects to make the following IP payments: $1.1 million in Q2 2008 and $0.8 million in Q3 2008. All other IP payments, including accrued interest, are due on or after May 2009.
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. 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(TM) (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, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008. 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 more than 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.
Forward-looking Statements
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 Company's financial guidance for 2008, the efficacy, safety and tolerability of Imagify, the NDA and MAA submission for Imagify and likelihood of regulatory approval, the commercial opportunity for Imagify and other business development efforts, including partnership discussions. There can be no assurance that regulatory authorities will accept the Company's NDA or MAA for Imagify or that Imagify will be approved for the indication the Company is seeking, or at all. There can be no assurance that partnership discussions will result in an agreement. 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 and uncertainties regarding the potential effects 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 three-month period ended March 31, 2008 and the Company's Annual Report on Form 10-K for the year ended December 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.
SOURCE: Acusphere, Inc.
Conway Communications Mary T. Conway, 617-244-9682 or Acusphere, Inc., 617-925-3444 Media: (617) 648-8800 IR@acusphere.com
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Companies: Acusphere Inc (ACUS)
Acusphere Gets FDA Review of Its Imagify NDA for Detection of Coronary Artery Disease - Zibb.com
MEADVILLE, Pa., Jul 03, 2008 (ASCRIBE NEWS via COMTEX) --
Acusphere announced that the New Drug Application (NDA) for approval to market its lead product candidate, Imagify (Perflubutane Polymer Microspheres for Injectable Suspension), has been accepted for review by the U.S. Food & Drug Administration (FDA).
According to the Company, Imagify is an ultrasound imaging agent for the detection of coronary artery disease, the leading cause of death in the United States.
The NDA includes data from studies of Imagify in more than 1,000 patients worldwide, including two pivotal international multi-center Phase III clinical trials, RAMP-1 and RAMP-2 (Real-Time Assessment of Myocardial Perfusion).
Imagify is the first ultrasound imaging agent designed to assess blood flow in the heart (myocardial perfusion), a sensitive marker of coronary artery disease. The Company believes it is also the first ultrasound imaging agent to demonstrate in large clinical trials clinically equivalent accuracy to nuclear stress testing, the current standard for assessing myocardial perfusion. Currently, perfusion information is not available using cardiac ultrasound, but must be obtained using a nuclear stress test, an expensive and time-consuming test that involves injecting the patient with a radioactive imaging agent. More than 10 million stress imaging procedures are done each year in the U.S. to detect coronary artery disease, as noted in the release.
Sherri C. Oberg, Acusphere's President and Chief Executive Officer, said, "We are very pleased that FDA has decided to accept our NDA submission for Imagify. In our view, Imagify could enable great strides forward in the detection of heart disease, with such important benefits as lower costs, speedier results and greater accessibility without exposure to radiation. We at Acusphere are eager to see those benefits brought to the aid of millions of patients and doctors in the U.S."
The FDA acceptance of the NDA submission indicates that the application is sufficiently complete to permit a substantive review and meets the threshold for filing. With a standard review, under the FDA Prescription Drug User Fee Act (PDUFA), the target action date is 10 months from the submission date, or February 28, 2009.
Imagify is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease.
Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology.
((Comments on this story may be sent to health@closeupmedia.com))
((Distributed via M2 Communications Ltd - http://www.m2.com))
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Comments on this story may be sent to health@closeupmedia.com
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News from Zibb.com
- Acusphere, Inc. Reports Q1 2008 Financial Results and Business Highlights - Zibb.com
- Acusphere Announces FDA Acceptance of Imagify(TM) NDA for Detection of Coronary Artery Disease -
- Acusphere, Inc. Reschedules IP Payments - Zibb.com
- Acusphere Gets FDA Review of Its Imagify NDA for Detection of Coronary Artery Disease - Zibb.com
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