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Acusphere Inc (ACUS) SEC Filing 10-Q Quarterly report for the period ending Monday, June 30, 2008

Acusphere Inc

CIK: 1115143 Ticker: ACUS

EXHIBIT 99.1

 

 

FOR IMMEDIATE RELEASE

 

Acusphere, Inc. Reports Q2 2008

Financial Results and Business Highlights

 

WATERTOWN, Mass., August 11, 2008 — Acusphere, Inc. (NASDAQ: ACUS) today reported financial results for the second quarter ended June 30, 2008 and commented on its financial results and business highlights.

 

Major Accomplishments

 

·                  Submitted New Drug Application (NDA) to the U.S. Food & Drug Administration for its lead product candidate, Imagify™ (Perflubutane Polymer Microspheres) for Injectable Suspension.

·                  Announced FDA acceptance of NDA, with expected target action date under the Prescription Drug User Fee Act (PDUFA) of February 28, 2009.

·                  Amended agreement with Nycomed to receive up to $750,000 in payments associated with qualification of commercial manufacturing plant in Tewksbury; such payments to be credited against Nycomed’s first product purchases of Imagify.

·                  Amended intellectual property agreements to shift a portion of the payments due in 2008 to beyond the PDUFA date in 2009.

·                  Successfully completed production of process validation batches.

 

Business Priorities

 

Acusphere’s key current priorities are:

 

·                  Continuing Company financing and partnership discussions for Imagify

 

The Company continues to support the Marketing Authorization Application (MAA) submission in Europe by Nycomed, its European partner, which remains planned for the second half of 2008.  Process validation batches were completed at the Tewksbury facility.  Preparations continue for the FDA pre-approval inspection which the Company believes will occur by early 2009.

 


The following information was filed by Acusphere Inc (ACUS) on Monday, August 11, 2008 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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SEC Filing Tools
Ticker: ACUS
CIK: 1115143
Form Type: 10-Q Quarterly Report
Accession Number: 0001104659-08-051874
Submitted to the SEC: Mon Aug 11 2008 4:12:34 PM EST
Accepted by the SEC: Mon Aug 11 2008
Period: Monday, June 30, 2008
Industry: Pharmaceutical Preparations

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