ACUSPHERE INC. - 500 Beiträge pro Seite

[bioperformer]

ACUSPHERE INC.








Spätestens seit gestern dürfte das noch recht kleine, jedoch nicht minder chancenreiche Unternehmen auf dem Einkaufszettel einiger größerer Adressen notiert worden sein.
Gründe gibt es dafür wohl einige, mit der Bekanntgabe einer 70 Mio.US$ schweren Kooperationsvereinbarung mit dem nicht börsennotiertem Unternehmen Nycomed sollte jedoch der Start in eine bessere Zukunft erfolgt sein.

Acusphere selbst sieht sich im Bereich der Medikamententwicklung bestens positioniert, arbeitet allerdings auch an optimierten Formulierungen bereits bestehender Medikamente.
In der Produktpipeline befinden sich derzeit drei Kandidaten in verschiedenen Fortschrittsphasen, in den Bereichen Kardiologie, Oncologie sowie Asthma angesiedelt.

Ai-700, derzeit in der 3.Phase, ist auch als indirekter Auslöser für den - zugegeben nicht ganz unerwarteten Kurssprung - von gut 20% zum Vortag zu werten.
Wirkungsfeld ist hier ein Ultraschallkontrastmittel für den Bereich Koronararterienleiden, der als Todesursache in US führend ist.

Auch die beiden hier noch nicht näher angesprochenen Produktanwärter Ai-850, sowie Ai-128 könnten kurstreibend wirken, zumal der Bereich "Nano" auch noch für die eine oder andere Überraschung sorgen wird.

Noch ein paar Zahlen zum Unternehmen:
Bei einem derzeitigen Kurs von 7,75 US$ ist Acusphere gerade mal mit lächerlichen 111 Mio. US$ bewertet.
Gut 31% der Shares befinden sich derzeit in Händen institutioneller Anleger, aktueller Buchwert derzeit bei 3,35 US$.

Fazit: Im Hinblick auf weitere, wahrscheinliche Kooperationsvereinbarungen für den amerikanischen Markt, -welche durchaus Volumina von 3-4facher Größenordnung der gestern veröffentlichten Vereinbarung haben könnten - steht das Unternehmen vor einer Neubewertung.
Das daraus entstehende Kurspotenzial sollte nicht unterschätzt werden, der Laden ist ein heißes Eisen.

[bioperformer]

Kooperationsvereinbarung vom 07.07.04 nochmals im Detail



Acusphere Announces $70 Million European Partnership for AI-700
WATERTOWN, Mass.--(BUSINESS WIRE)--July 7, 2004--Acusphere, Inc. (NASDAQ: ACUS), a specialty pharmaceutical company that develops drug products using its porous microparticle technology, announced today that it has entered into a Collaboration, License and Supply Agreement with Nycomed for the European development and marketing rights to Acusphere`s lead product candidate AI-700. Nycomed is a pan-European pharmaceutical company with about $725 million in annual revenues. AI-700 is an ultrasound contrast agent currently in Phase 3 clinical trials for assessing myocardial perfusion in the diagnosis of coronary heart disease, a leading cause of death in the United States and Europe.

As part of the Agreement, Nycomed will provide $70 million in license fees, research and development funding, and milestone payments, including $12 million in payments over the first two years. These near-term payments include $4 million in upfront license fees and $8 million in research and development funding payable in eight equal quarterly installments. An additional $58 million in milestone payments are related to regulatory approvals and achievement of certain sales goals. In addition, Acusphere will be paid to manufacture the product for Nycomed and will receive royalties on Nycomed`s sales of AI-700. Nycomed will be responsible for sales, marketing and the regulatory submissions required for marketing throughout its sales territory, which includes the member states of the European Union, as well as Russia/CIS and Turkey.

"As one of the few pan-European pharmaceutical companies, Nycomed is an excellent partner to develop and market AI-700 throughout Europe," commented Sherri C. Oberg, President and CEO of Acusphere. "Nycomed brings a long, successful heritage in building close relations with health care professionals throughout the European hospital-specialist sector. This heritage, combined with an extensive European market presence, and a clear strategy to build a strong cardiovascular portfolio, makes Nycomed an experienced partner with a positive reputation among European cardiologists. Nycomed has sales forces in 19 European countries and its strategy to focus its marketing and sales activities almost exclusively in Europe is highly compatible with our commercial strategy in the United States, where we currently plan to build our own marketing and sales capability for AI-700. As a pharmaceutical company with over $700 million in revenues, Nycomed has a sophisticated marketing and sales capability, along with an ability to focus targeted attention on AI-700, which has the potential to represent a sizable proportion of Nycomed`s overall sales."

Hakan Bjorklund, CEO of Nycomed commented, "We are enthusiastic about the potential market opportunity for AI-700 in Europe and are impressed with the clinical results to date. AI-700 is an excellent match with our cardiovascular product focus. With the successful in-licensing of Angiox(TM) (bivalirudin), a thrombin-specific anticoagulant for percutaneous coronary intervention, which is scheduled for pan-European launch later this year, we are already in the process of developing and training a hospital specialist sales force that will call on our customer base of cardiologists in Europe. With AI-700, we are excited to be participating in the commercialization of a product with such great potential to improve the diagnosis and management of coronary heart disease. We are committed to working closely with Acusphere and we are looking forward to supporting the MAA filing in the first half of 2006, consistent with Acusphere`s planned NDA filing date."

Ultrasound is the only frequently used imaging technique without a commercially significant imaging agent. Acusphere has designed AI-700 to work with ultrasound in the assessment of myocardial perfusion (blood flow in the heart muscle), a sensitive marker of coronary heart disease. In 2002, an estimated 9.5 million procedures in the U.S. and 1.5-2.0 million procedures in Europe were performed to screen patients with suspected coronary heart disease, primarily using nuclear imaging. AI-700-enhanced ultrasound is being developed as a cost-effective and convenient alternative to nuclear imaging.

Ferghana Partners Group (New York and London), a specialist investment bank in the life sciences field, acted as financial and transaction advisor to Acusphere on this Agreement with Nycomed.

Conference Call Information

Acusphere will host a conference today, July 7, 2004, at 11:00 a.m. (EDT) to discuss this Agreement and answer questions. The conference may be heard live via the investor relations section of our website at www.acusphere.com or by dialing 1-800-599-9795, using the confirmation code: 47942555. For participants dialing in from outside the U.S. please use the number 1-617-786-2905 using the same confirmation code, 47942555. After the conference call, a replay of the call will be made available for thirty days via our web site and a telephone replay will be available through July 14, 2004 by dialing 1-888-286-8010, using the confirmation code: 20088851.

About Acusphere, Inc.

Acusphere 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 in clinical development and 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, AI-700, is a cardiovascular drug in Phase 3 clinical development in the U.S. and Europe. For more information about Acusphere visit the Company`s web site at www.acusphere.com.

About Nycomed

Nycomed is a pharmaceutical company differentiating itself by its European focus. The company`s capabilities include product sourcing, late-stage clinical trials, registration, pricing and reimbursement negotiation and product life-cycle management. Dedicated sales teams target general practitioners, pharmacists and hospital specialists, including cardiologists. With 2,800 people, mostly in marketing & sales, Nycomed covers 19 European markets including the Russia/CIS. Products are also exported to other countries including Japan and the USA. Nycomed is a privately-owned company with 2003 revenues of EUR 635.5 million. Further information is available at: www.nycomed.com.

"Acusphere" and "AI-700" are trademarks of Acusphere, Inc.

This Release contains forward-looking statements, including statements regarding development, regulatory filings, milestone payments and commercial potential of AI-700. 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, uncertainties associated with research, development, testing and related regulatory approvals, unproven markets, future capital needs and uncertainty of additional financing, competition, uncertainties associated with intellectual property, complex manufacturing, high quality requirements, dependence on third-party manufacturers, suppliers and collaborators, lack of sales and marketing experience, 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 March 31, 2004. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this 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 Release or to reflect the occurrence of unanticipated events.


CONTACT: Acusphere, Inc.
John F. Thero
Investors:
617-925-3444
[e-mail]
or
Media:
617-648-8800

SOURCE: Acusphere, Inc.

[bioperformer]

Press Release Source: Acusphere, Inc.


Acusphere Enters into Lease Agreement for Manufacturing Facility
Friday July 23, 8:42 am ET


WATERTOWN, Mass.--(BUSINESS WIRE)--July 23, 2004--Acusphere, Inc. (NASDAQ: ACUS - News), a specialty pharmaceutical company that develops drug products using its proprietary porous microparticle technology, announced today that it has entered into a lease agreement for 58,000 square feet of commercial manufacturing space in Tewksbury, Massachusetts. Acusphere intends to develop this facility to meet its anticipated initial commercial production needs for AI-700, the company`s lead drug, currently in Phase 3 clinical trials. AI-700 is an ultrasound contrast agent in development for the detection of coronary heart disease, the leading cause of death in the United States.
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Acusphere currently manufactures AI-700 outside of Massachusetts. The Tewksbury facility is located within 30 miles of Acusphere`s headquarters in Watertown, Massachusetts. This proximity, and the availability and experience of local resources, are expected to provide operational efficiencies.

Earlier this month, Acusphere announced a $70 million partnership agreement with Nycomed, a pan-European pharmaceutical marketing company. Under this agreement, Acusphere will manufacture AI-700 for Nycomed`s sale in Europe. The Tewksbury facility, subject to completion of remodeling and regulatory approvals, will be designed to manufacture product for sale in the US, Europe and elsewhere worldwide.

"Leasing additional manufacturing space at this time reflects our continued optimism in AI-700. We plan to have the manufacturing facility qualified and ready in time for our NDA filing," said Sherri C. Oberg, Acusphere President and CEO.

In conjunction with this announcement, Acusphere affirmed that it remains on track for its previously announced goals of enrolling 300 patients in its Phase 3 clinical program for AI-700 by the end of 2004 and filing an NDA for AI-700 in the first half of 2006. Acusphere further confirmed its previously announced guidance for 2004 operating expenses, which are expected to be in the range of $30-35 million, excluding stock-based compensation costs, with the majority of these operating expenses incurred for research and development.

About Acusphere, Inc.

Acusphere 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 in clinical development and 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, AI-700, is a cardiovascular drug in Phase 3 clinical development. AI-700 is designed to be used in a preferred alternative procedure to the estimated 9.5 million procedures 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.

This Release contains forward-looking statements, including statements regarding Acusphere`s ability to commercialize AI-700 and to develop and obtain regulatory approvals necessary to utilize its commercial manufacturing space and the cost of such operations. 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, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding the ultimate outcome of Acusphere`s Phase 3 clinical trials for AI-700, unproven markets, future capital needs and uncertainty of additional financing, competition, uncertainties associated with intellectual property, complex manufacturing, high quality requirements, dependence on third-party manufacturers, suppliers and collaborators, lack of sales and marketing experience, 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 March 31, 2004. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this 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 Release or to reflect the occurrence of unanticipated events.



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Contact:
Acusphere, Inc.
John F. Thero
Sr. Vice President and CFO
Investors:
Tel: [phone]
Email: [e-mail]
Media: 617-648-8800



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Source: Acusphere, Inc.

[bioperformer]

Acusphere Announces $21.5 Million Private Financing
Monday August 2, 8:45 am ET


WATERTOWN, Mass.--(BUSINESS WIRE)--Aug. 2, 2004--Acusphere, Inc. (NASDAQ: ACUS - News), a specialty pharmaceutical company that develops drug products using its proprietary porous microparticle technology, announced today that it has entered into definitive purchase agreements for a $21.5 million private placement of newly issued shares of common stock and the concurrent issuance of warrants for the purchase of additional shares of common stock to institutional and accredited investors. The financing is expected to occur in two closings, with the first closing resulting in aggregate gross proceeds to the Company of approximately $17.9 million, scheduled to be completed early this week, subject to customary closing conditions. A second and final closing resulting in additional gross proceeds of approximately $3.6 million should occur later this year subject to receiving shareholder approval in accordance with the marketplace rules of The Nasdaq Stock Market, Inc. and customary closing conditions.
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Subject to shareholder approval for the second closing, the Company will issue in the financing an aggregate of approximately 3.4 million shares of common stock at a price of $6.25 per share, together with warrants to purchase up to 688,000 additional shares of common stock at an exercise price of $8.50 per share. SG Cowen & Co., LLC is serving as exclusive placement agent for the financing and will receive a customary fee from the Company.

Net proceeds from the financing are expected to be used to fund the development program for Acusphere`s lead product candidate, AI-700, an ultrasound contrast agent currently in Phase 3 clinical trials for detecting myocardial perfusion, a sensitive marker of coronary heart disease, which is the leading cause of death in the United States. Net proceeds from the financing are also expected to be used for working capital and general corporate purposes.

"This additional funding provides Acusphere with sufficient cash for our currently planned operations into 2006," commented Sherri C. Oberg, President and Chief Executive Officer of Acusphere. "We are gratified by the confidence our investors have shown in Acusphere`s technology, management and business strategy, building upon the momentum we established with our recent European licensing agreement with Nycomed and our lease agreement for commercial manufacturing space. We will continue to work hard to reward that confidence in the future for the benefit of all shareholders."

At the first closing of the financing, the Company will issue approximately 2.9 million shares of common stock and warrants to purchase up to approximately 573,000 additional shares of common stock, resulting in gross proceeds to the Company at this first closing of approximately $17.9 million. No shareholder approval is required for this first closing.

The Nasdaq Stock Market, Inc. requires shareholder approval for the issuance of common stock (or securities convertible into or exercisable for common stock) in an amount greater than 20% of the Company`s current outstanding common stock or voting power on a pre-transaction basis, if such securities are sold at a per share price less than the greater of the market value or book value of the Company`s common stock. Prior to the issuance of the securities in the financing, the Company had approximately 14.3 million shares of common stock outstanding. Therefore, the Company intends to file a preliminary proxy statement with the Securities and Exchange Commission as soon as practicable and to seek shareholder approval for the issuance of approximately 574,000 shares of common stock and warrants to purchase up to approximately 115,000 additional shares of common stock, resulting in gross proceeds to the Company of approximately $3.6 million, at the second and final closing, or that portion of the total securities proposed to be issued in the financing that exceeds the Nasdaq 20% threshold. The holders of approximately 35% of the outstanding shares of the Company`s common stock on a pre-transaction basis have agreed with the investors participating in the financing to vote any shares then held by them in favor of the issuance of the securities proposed to be issued at the second and final closing. Information regarding this transaction and the scheduling of this shareholder vote will be included in proxy materials that will be sent to shareholders.

The shares of common stock and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange commission or an applicable exemption from the registration requirements. The shares and warrants were offered and sold only to institutional and accredited investors. The Company has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock issued in the private placement and the shares of common stock issued upon exercise of the warrants.

This news release is not an offer to sell or the solicitation of an offer to buy the shares of common stock or warrants to purchase shares of common stock or any other securities of the Company.

Financial Results and Conference Call Information

Acusphere plans on the evening of Thursday, August 5, 2004 to release information regarding its second quarter operation results and to follow that release that day with a conference call commencing at 5:30 p.m. (Eastern Time). The conference call will include discussion of the Company`s operating results, the above described financing and other operational matters, followed by answers to 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 1-800-659-1966, using the confirmation code: 70040791. For participants dialing in from outside the U.S. please call 1-617-614-2711 using the same confirmation code, 70040791. After the conference call, a replay of the call will be made available for 30 days via the Company`s web site and a telephone replay will be available through September 4, 2004 by dialing 1-888-286-8010, or internationally 1-617-801-6888, using the confirmation code: 49969147.

About Acusphere, Inc.

Acusphere (NASDAQ:ACUS - News) 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 in clinical development and 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, AI-700, is a cardiovascular drug in Phase 3 clinical development. AI-700 is designed to be used in a preferred alternative procedure to the estimated 9.5 million procedures 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.

Forward-looking Statements

This Release contains forward-looking statements, including statements regarding the Company`s expectations regarding its use of the proceeds from the transaction, financial requirements, intent and ability to solicit shareholder approval for this transaction and file a related proxy statement in connection therewith, and intent and ability to file a registration statement covering the securities offered in this transaction. The Company`s actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including the risk that the private placement may not be completed in a timely manner if at all, the risk that shareholder approval may not be obtained for the proposed second closing of the private placement, anticipated operating losses, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding the ultimate outcome of Acusphere`s Phase 3 clinical trials for AI-700, unproven markets, future capital needs and uncertainty of additional financing, competition, uncertainties associated with intellectual property, complex manufacturing, high quality requirements, dependence on third-party manufacturers, suppliers and collaborators, lack of sales and marketing experience, 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 March 31, 2004. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this 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 Release or to reflect the occurrence of unanticipated events.

Additional Information

In connection with the private placement, Acusphere plans to file a proxy statement and other relevant documents with the Securities and Exchange Commission ("SEC") relating to a solicitation of proxies from its stockholders in connection with a special meeting of stockholders. STOCKHOLDERS OF ACUSPHERE ARE ADVISED TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. The proxy statement will be available free of charge at www.sec.gov. In addition, investors and security holders may obtain free copies of the proxy statement and other documents filed with the SEC when they become available by contacting Investor Relations, Acusphere, Inc., 500 Arsenal Street, Watertown, MA 02472 (Telephone: [phone]). Information regarding the identity of the persons who may, under SEC rules, be deemed to be participants in the solicitation of stockholders of Acusphere, and their interests in the solicitation, will be set forth in a proxy statement that will be filed by Acusphere with the SEC.



--------------------------------------------------------------------------------
Contact:
Acusphere, Inc.
John F. Thero, Sr. Vice President and CFO
Investors: 617-925-3444
[e-mail]
Media: 617-648-8800



--------------------------------------------------------------------------------
Source: Acusphere, Inc.

[mystreet]

Phase III (!!) und Mkap < 100 Mio
gibts nicht? gibts doch !!!!!!!!!
Business Editors/Healthcare Editors

WATERTOWN, Mass.--(BUSINESS WIRE)--Dec. 16, 2004--Acusphere, Inc.(NASDAQ:ACUS) today announced enrollment of 300 patients in its Phase3 clinical program for AI-700, its lead product candidate.Cumulatively enrolling 300 patients in this program before the end of2004 had been a publicly stated goal of the Company. AI-700 is acardiovascular drug designed to enable ultrasound to compete moreeffectively with nuclear stress testing, the leading procedure fordetecting coronary heart disease. Currently an estimated 9.5 millionprocedures are performed each year in the United States for detectingcoronary heart disease.
The AI-700 Phase 3 clinical program includes a pilot phase fortraining of new clinical sites, and two simultaneous pivotal trials.More than 20 medical centers in the United States, Europe andAustralia are actively enrolling in the pivotal phase of the Phase 3program. Acusphere estimates that 600 patients in total will berequired to complete enrollment in its pivotal trials, and plans tocomplete enrollment of these patients in the second half of 2005.
"We are pleased with the continued progress we are making inenrolling patients in the AI-700 clinical trials. We are proud to haveaccomplished this important milestone within the timeframe weforecasted more than a year ago, and we thank the clinicalinvestigators, patients and all members of our clinical support teamfor their dedication in advancing these clinical trials." commentedSherri C. Oberg, Acusphere´s President and Chief Executive Officer."Heart disease remains the number one cause of death for men and womenin the United States and in many other areas of the world. We believethat AI-700 will lead to a relatively fast and inexpensive means ofscreening patients suspected of having heart disease. We haveestablished a track record of consistently delivering on our importantmilestones in a timely manner and we remain committed to completingenrollment in our pivotal trials in the second half of 2005."