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Acusphere, Inc. Appoints Michael Slater SVP Regulatory Affairs and Operations Replacing Dennis Bucceri (Business Wire)
biz.yahoo.com | Sep 25, 2008
Acusphere, Inc. Appoints Michael Slater SVP Regulatory Affairs and Operations Replacing Dennis Bucceri. - WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (NASDAQ: ACUS - News) today announced that Michael R.
Acusphere lays off 24 workers
www.bizjournals.com | Jul 28, 2008
Acusphere estimates the measures will save about $2.1 million. The goal is to decrease operating costs as the company waits for U.S. Food and Drug Administration approval of Imagify, its new imaging agent. Acusphere estimates the FDA will make a decision on Imagify, by Feb. 28, 2009.
http://www.bizjournals.com/boston/stories/2008/07/28/daily10.html?ana=from_rss
Acusphere Inc. Announces Staff Reductions
www.biospace.com | Jul 28, 2008
Other cost cutting measures include management salary concessions and the reduction in use of consultants and other contract personnelWATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere Inc. (NASDAQ: ACUS) announced today that it has reduced its employee base by 24 people, or about 24%, primarily
http://www.biospace.com/news_story.aspx?StoryID=104812&full=1
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
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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 Inc.
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http://www.biospace.net/company_profile.aspx?CompanyId=261404
Apria - resources - News
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).
Pharmacy Choice - Pharmaceutical News - Acusphere to Present at the 8th US-Japan Symposium on Drug
8th US-Japan Symposium on Drug Delivery Systems WATERTOWN, Mass.--(BUSINESS WIRE)--Dec. 21, 2005--Acusphere, Inc. (NASDAQ:ACUS) today announced today that Dr.
http://www.pharmacychoice.com/News/article.cfm?Article_ID=18887
News from Zibb.com
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Acusphere Inc. (ACUS) Corporate Event Announcement Notice - Zibb.com
Aug 11, 2008 (Wall Street Horizon via COMTEX) --
Acusphere Inc. (ACUS)
Expected next earnings release: Announcement date: 8/11/2008 - After Market Earnings Quarter: Q2 Announcement Status: Verified
Tags: corporate earnings market
Companies: Acusphere Inc (ACUS)
Acusphere Receives Letter from NASDAQ Citing Failure to Comply with the Minimum Stockholders'
WATERTOWN, Mass., Aug 13, 2008 (BUSINESS WIRE) --
Acusphere, Inc. (NASDAQ: ACUS) announced today that on August 12, 2008, the company received a letter from NASDAQ indicating that based on the company's stockholders' equity as reported in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, Acusphere does not comply with the minimum stockholders' equity requirement of $10 million for continued listing on The NASDAQ Global Market as set forth in NASDAQ Marketplace Rule 4450(a)(3). As a result, the company's common stock will be subject to delisting from The NASDAQ Global Market unless Acusphere adequately addresses this deficiency at the company's hearing before the NASDAQ Listing Qualifications Panel (the "Panel") scheduled for the first half of September 2008. At the hearing, the company will request continued listing on either The NASDAQ Global Market or The NASDAQ Capital Market based upon its plan for demonstrating compliance with the applicable listing requirements. Pursuant to the NASDAQ Marketplace Rules, the Panel has the authority to grant the company up to an additional 180 days from the date of NASDAQ's letter regarding the minimum bid price deficiency, July 14, 2008 (i.e., January 9, 2009), to implement its plan of compliance. There can be no assurance that the Panel will grant Acusphere's request for continued listing on NASDAQ. In the event the Panel denies the company's request for continued listing, Acusphere's common stock may become eligible for quotation and trading on the OTC Bulletin Board.
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 possible delisting from the NASDAQ Global Market. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including those 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 June 30, 2008. 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.
Acusphere, Inc. Lawrence A. Gyenes, 617-648-8800 Chief Financial Officer or Investors: 617-925-3444 IR@acusphere.com or Media: 617-648-8800
Tags: annual report cardiovascular disease drugs equity market nasdaq nuclear pharmaceuticals securities technology web
Companies: Acusphere Inc (ACUS)
Acusphere Announces Staff Reductions - Zibb.com
WATERTOWN, Mass., Jul 28, 2008 (BUSINESS WIRE) --
Acusphere Inc. (NASDAQ: ACUS) announced today that it has reduced its employee base by 24 people, or about 24%, primarily in functions related to manufacturing of its lead product candidate, Imagify(TM) (Perflubutane Polymer Microspheres) for Injectable Suspension. In addition, all senior managers at the Vice President level and above are taking salary reductions of 10% or more effective August 1, 2008, to further decrease operating costs while Acusphere awaits U.S. Food & Drug Administration (FDA) review and potential approval of its New Drug Application (NDA) for Imagify. The Company has also given notification of termination to certain consultants and contractors. With the announced reductions, total employment at Acusphere is now 77 personnel.
In late June, FDA accepted Acusphere's NDA submission for Imagify, indicating that the application was sufficiently complete to permit a substantive review. With a standard review under the Prescription Drug User Fee Act (PDUFA), the target action date is 10 months from the submission date, or February 28, 2009. At the PDUFA date, FDA will either approve Imagify or provide a complete response letter on its review of the Imagify NDA. The reductions announced today, in combination with previously announced cash savings from patent payment deferrals, manufacturing cost reimbursements and the renegotiation of other contracts currently underway, are intended to support the Company's goal of stretching its existing financial resources and reduce its financing needs prior to the PDUFA date. The Company believes that potential partnering and financing terms could be more favorable following the PDUFA date.
Total annualized cash savings from reductions in staff and senior management salaries are estimated to be approximately $2.1 million. The Company estimates it will take a one-time charge in the third quarter of 2008 of approximately $0.3 million associated with the staff reductions. In addition, notice of termination to certain consultants and contractors will result in estimated annual savings of approximately $2.0 million. When combined with the patent payment deferrals and manufacturing cost reimbursements, the actions announced today bring total cash savings prior to the PDUFA date to approximately $6.4 million.
Sherri C. Oberg, Acusphere's President and Chief Executive Officer, said, "These decisions are extremely difficult but both appropriate and necessary given the current financing environment for life sciences companies, our continued belief that Imagify will be approved, our improved prospects for financing on more favorable terms after the PDUFA date and our progress in manufacturing. We greatly appreciate the dedicated efforts of employees who have enabled us to reach this critical point for Imagify."
Members of senior management have agreed to revisions in their compensation that closely align their interests with those of shareholders. In exchange for reducing salary, which will help Acusphere move closer to its goal of minimizing financing needs prior to the PDUFA date, each senior management member will receive a cash incentive and option grants that will only be paid out or vested if the Company is able to attract meaningful capital post-PDUFA date. The magnitude of the cash incentive and option grant varies with the size of the salary reduction taken.
As of June 30, 2008, Acusphere had unaudited cash and short-term investments of approximately $12 million. With the reductions announced to date, the Company anticipates a quarterly cash spend rate for the third and fourth quarters of 2008 of $8 to $9 million. On that basis, the Company's available funding should carry it well into the fourth quarter of this year. The Company expects to report its financial results for the quarter ended June 30, 2008 on August 11, 2008.
Conference Call Information
Acusphere plans to hold a conference call with investors today, Monday, July 28, 2008, commencing at 4:30 PM (Eastern Time) to discuss this development. The conference call 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 1-866-770-7129, or internationally 1-617-213-8067, using the confirmation code: 44306568. 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 August 28, 2008 by dialing 1-888-286-8010, or internationally 1-617-801-6888, using the confirmation code: 37370986.
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 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, 2008. 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.
Acusphere, Inc. Investors: Lawrence A. Gyenes, 617-925-3444 SVP & CFO IR@acusphere.com or Media: 617-648-8800
Tags: annual report cardiovascular ceo clinical commercial conference contract contractors disease drugs employment environment fda financial results government manufacturing market nasdaq nuclear patent pharmaceuticals president property research salaries securities technology trial web
Companies: Acusphere Inc (ACUS)
Acusphere, Inc. Appoints Michael Slater SVP Regulatory Affairs and Operations Replacing Dennis
WATERTOWN, Mass., Sep 25, 2008 (BUSINESS WIRE) --
Acusphere, Inc. (NASDAQ: ACUS) today announced that Michael R. Slater will assume the position of Senior Vice President, Regulatory Affairs and Operations effective September 29, 2008, following the decision of Dennis Bucceri to leave the company for another opportunity. Mr. Slater, currently Senior Vice President, Operations, oversaw regulatory affairs at Acusphere prior to Mr. Bucceri's appointment in 2007. He has also held this position in other companies, including Biogen and Anika Therapeutics.
Sherri C. Oberg, President and CEO of Acusphere, said, "We are disappointed to lose Dennis, but respect his decision to return to a larger, more established company. We are confident that Michael Slater will be able to effectively step back into the regulatory affairs role and continue to push forward with the remaining critical milestones in the review and ultimately approval by the U.S. Food and Drug Administration (FDA) of our lead product, Imagify(TM). As I've said before, Greater Boston is a competitive arena for experienced biotech management. Dennis' role in shepherding Imagify, one of the few blockbuster products currently moving through FDA review, makes him highly attractive to a host of other larger companies. We thank him and wish him continued success."
The expected target action date for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension, under the Prescription Drug User Fee Act (PDUFA) is February 28, 2009.
Mr. Slater has served as Senior Vice President, Operations at Acusphere since 2001. Prior to joining Acusphere, he was Vice President of Operations and Vice President of Quality Systems and Regulatory Affairs at Anika Therapeutics, Inc. Mr. Slater has also served as Vice President of Regulatory Affairs at Biogen, Inc., Director of Corporate Regulatory Affairs at Biogen S.A., an independent consultant to the biopharmaceutical industry, as well as Executive Vice President, Development Operations for ImmuLogic Pharmaceutical Corporation. While at Hoechst Pharmaceuticals he held various positions including Senior Manager, Medical Services. Mr. Slater holds a B.S. in Information Science from the Metropolitan University of Leeds, England.
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, ImagifyTM (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 and filed in June 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 efficacy, safety and tolerability of Imagify, the NDA 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 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 Annual Report on Form 10-K for the year ended December 31, 2007 and its Form 10-Q for the quarter ended June 30, 2008. 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.
Acusphere, Inc. Lawrence A. Gyenes, 617-648-8800 Chief Financial Officer or Investors: 617-925-3444 IR@acusphere.com
Tags: appointment biotechnology business cardiovascular ceo clinical commercial consultant corporate disease drugs england executive fda food government manufacturing market medical nasdaq nuclear partnership pharmaceuticals president products property research securities technology trial university web
Companies: Acusphere Inc (ACUS)
News from Zibb.com
- Acusphere Inc. (ACUS) Corporate Event Announcement Notice - Zibb.com
- Acusphere Receives Letter from NASDAQ Citing Failure to Comply with the Minimum Stockholders'
- Acusphere Announces Staff Reductions - Zibb.com
- Acusphere, Inc. Appoints Michael Slater SVP Regulatory Affairs and Operations Replacing Dennis
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