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Critical Therapeutics Announces the Issuance of Four New Patents for Its Alpha-7 and HMGB1 Preclinical Programs


Thursday, October 11, 2007

Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced the issuance of four new U.S. patents during 2007 that strengthen the Company’s intellectual property protecting its two pre-clinical programs, alpha-7 nicotinic acetylcholine receptor (Alpha-7) and High Mobility Group Box 1 (HMGB1). The patents relate to methods and molecules that act as agonists of the Alpha-7 receptor, or target the HMGB1 protein, to treat inflammatory disease.

Alpha-7

The Alpha-7 pre-clinical program is directed at the discovery and development of novel small molecule drugs for the treatment of both chronic and severe acute inflammation. The Company has a number of promising candidates and has selected a development compound that is currently in pre-clinical development. Critical Therapeutics expects to file an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) during the second half of 2008.

  • US Patent number 7,273,872, "Inhibition of Inflammation Using Alpha-7 Receptor-binding Cholinergic Agonists," claims a method of treating a patient suffering from inflammatory disease with selective Alpha-7 agonists. Additional claims are directed to the use of specific known selective Alpha-7 agonists. This patent issued on September 25, 2007.
  • US Patent number 7,238,715, "Treatment of Pancreatitis Using Alpha-7 Receptor-binding Cholinergic Agonists," claims a method of treating a subject suffering from pancreatitis with selective Alpha-7 agonists. Additional claims are directed to the use of specific known selective Alpha-7 agonists. This patent issued on July 3, 2007.

HMGB1

The HMGB1 program, which is being conducted in collaboration with MedImmune, Inc., a biotechnology company wholly owned by AstraZeneca plc, is focused on the generation and development of therapeutic antibodies to HMGB1 for the treatment and prevention of acute and chronic inflammatory diseases, including fully human monoclonal antibodies that neutralize the pro-inflammatory effects of the cytokine HMGB1. The collaboration has identified potential clinical candidates for acute and chronic diseases, including arthritis, lupus and sepsis. The Company anticipates that the collaboration will select a final clinical development candidate for at least one of these indications within the next 12 months.

  • US Patent number 7,192,917, "Antagonists of HMGB1 for Treating Inflammatory Conditions," claims a method for treating conditions characterized by the activation of the inflammatory cytokine cascade, including sepsis, rheumatoid arthritis, lupus, septic shock and acute respiratory distress syndrome, comprising treatment with an effective amount of an antibody that binds to HMGB1 and inhibits the interaction between HMGB1 and RAGE. This patent issued on March 20, 2007.
  • US Patent number 7,220,723, "Inhibitors of the Interaction between HMGB1 Polypeptides and Toll-like Receptor 2 as Anti-inflammatory Agents," claims a method of using a soluble toll-like receptor 2 (sTLR2) that inhibits the interaction between a sTLR2 and an HMGB1 polypeptide to treat an inflammatory condition. This patent issued on May 22, 2007.

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 two FDA-approved drugs for the prevention and chronic treatment of asthma in patients 12 years of age and older: twice-daily ZYFLO CRTM (zileuton extended-release tablets) and ZYFLO® (zileuton immediate-release tablets). Critical Therapeutics is working to develop products for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is developing therapies directed toward the body's inflammatory response. Critical Therapeutics is located in Lexington, Mass. For more information, please visit www.crtx.com.

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 effectiveness, strength and enforceability of our patent and other intellectual property protection for Alpha-7 and HMGB1 and the possible timing and results for future development, safety and efficacy of the Alpha-7 and HMGB1 programs, including the status, timing and results of the filing of an IND for the Alpha-7 and the selection of a clinical development candidate for the HMGB1 program, 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: our ability to obtain, maintain and enforce patent and other intellectual property protection for Alpha-7, HMGB1, ZYFLO CR, our discoveries and our drug candidates; the results of preclinical studies and clinical trials with respect to our products under development and whether such results will be indicative of results obtained in later clinical trials; our ability to successfully market and sell ZYFLO CR and ZYFLO, including the success of our co-promotion arrangement with Dey, L.P. (DEY); our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO CR and ZYFLO; patient, physician and third-party payor acceptance of ZYFLO CR and ZYFLO as a safe and effective therapeutic product; adverse side effects experienced by patients taking ZYFLO CR and ZYFLO; our heavy dependence on the commercial success of ZYFLO CR and ZYFLO; our ability to maintain regulatory approvals to market and sell ZYFLO CR and ZYFLO; our ability to successfully enter into additional strategic co-promotion, collaboration or licensing transactions on favorable terms, if at all; 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; and our dependence on our strategic collaboration with MedImmune, Inc. 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.

In addition, the statements in this press 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® is a registered trademark of Critical Therapeutics, Inc.

ZYFLO CRTM is a trademark of Critical Therapeutics, Inc.



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