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Critical Therapeutics Announces Beckman Coulter Exercises Option to Continue HMGB1 Diagnostic Development.

LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that Beckman Coulter, Inc. has exercised its option to continue to license patent rights relating to the use of High Mobility Group Box 1 (HMGB1) technology to develop an immunoassay for detection and diagnosis of inflammatory diseases. Beckman Coulter has paid Critical Therapeutics a product development fee as a result of exercising its option and has agreed to begin formal product development of an HMGB1 diagnostic. In January 2005, Critical Therapeutics originally entered into a license agreement with Beckman Coulter relating to the development of diagnostic products for measuring HMGB1. Under the terms of the license agreement, Critical Therapeutics is entitled to receive a milestone payment upon the achievement of the first commercial sale of a licensed product and royalties on net sales of licensed products by Beckman Coulter.

"The role of HMGB1 in acute and chronic disease is an emerging area of research and development in critical care medicine," said Frank Thomas, President and Chief Executive Officer of Critical Therapeutics. "We believe that a test to detect and measure levels of HMGB1 in the bloodstream could play an important role in diagnosing acute diseases resulting in multi-organ failure, including sepsis and septic shock, as well as chronic inflammatory diseases, such as rheumatoid arthritis."

The research being performed by Beckman Coulter relating to an HMGB1 diagnostic test is occurring concurrently with the Company's collaboration with MedImmune to advance a human HMGB1 antibody candidate into clinical trials. Critical Therapeutics exclusively licensed its HMGB1 patent estate for the treatment and prevention of diseases to MedImmune in 2003. The agreement calls for MedImmune and Critical Therapeutics to collaborate on research and development of antibodies and other drug products targeting HMGB1 for the potential treatment of acute and chronic inflammatory diseases. The collaboration is in the process of selecting a candidate for clinical development.

About HMGB1

HMGB1 has been identified as a potential late mediator of inflammation-induced tissue damage. Unlike other previously identified mediators of the cytokine cascade, HMGB1 is expressed much later in the cascade and persists at elevated levels for a longer period of time. HMGB1's delayed and prolonged expression may offer a new therapeutic target with a potentially broader treatment window for acute diseases resulting in multiple organ failure, including sepsis and septic shock, as well as for chronic diseases associated with the inflammatory response mediated by cytokines, such as rheumatoid arthritis.

About Critical Therapeutics

Critical Therapeutics, Inc. is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to ZYFLO[R] (zileuton tablets), which is marketed in the United States for the prevention and chronic treatment of asthma in patients 12 years of age and older. Critical Therapeutics is working to expand its zileuton franchise by developing a twice daily, controlled-release formulation for the prevention and chronic treatment of asthma and an intravenous formulation for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is collaborating with MedImmune, Inc. to design antibody therapies that treat acute and chronic diseases triggered by the inflammatory cytokine HMGB1. Research pipeline programs include lifecycle management to extend the zileuton franchise and an alpha-7 project for the treatment of inflammation. Critical Therapeutics is located in Lexington, Mass. For more information, please visit

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, statements regarding the potential role of HMGB1 in diagnosing and treating disease; possible future payments to us under the license agreement with Beckman Coulter; our development plans for an HMGB1 diagnostic; and all other statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "will," "would" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties relating to: future development and commercialization efforts by Beckman Coulter of an HMGB1 diagnostic; the expected timing and outcome of the New Drug Application (NDA) for the controlled-release formulation of zileuton (CR) and related discussions with the FDA; our ability to transition our management team effectively; our ability to successfully enter into strategic co-promotion, collaboration or licensing transactions on favorable terms, if at all; our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO, and, if approved, zileuton CR; our ability to successfully market and sell ZYFLO with a reduced sales force; patient, physician and third-party payor acceptance of ZYFLO and, if approved, zileuton CR, as a safe and effective therapeutic product; adverse side effects experienced by patients taking ZYFLO and, if approved, zileuton CR; our heavy dependence on the commercial success of ZYFLO and, if approved, zileuton CR; our ability to maintain regulatory approvals to market and sell ZYFLO and, if approved, zileuton CR; conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; our ability to obtain the substantial additional funding required to conduct our research, development and commercialization activities; our dependence on our strategic collaboration with MedImmune, Inc.; and our ability to obtain, maintain and enforce patent and other intellectual property protection for ZYFLO, our discoveries and drug candidates. These and other risks are described in greater detail in the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q and other filings that we make with the Securities and Exchange Commission. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

The statements in this release reflect our expectations and beliefs as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

ZYFLO([R]) is a registered trademark of Critical Therapeutics, Inc.
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Publication:Business Wire
Date:Feb 13, 2007
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