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Critical Therapeutics Licenses Rights for Vagus Nerve Stimulation Device to Innovative Metabolics.

Company Retains Rights to Therapeutic Applications Utilizing Alpha-7 Nicotinic Receptor Agonist Drugs

LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) has granted an exclusive worldwide license to Innovative Metabolics, Inc. for intellectual property rights related to the development and commercialization of medical device approaches to stimulating the vagus nerve, which is believed to play a role in regulating the body's inflammatory response.

"Licensing these patent rights allows us to monetize an asset that is not an area of focus for the Company," said President and Chief Executive Officer Frank Thomas. "While we have opted to out-license patent rights for both electrical and mechanical stimulation of the vagus nerve, we have retained our intellectual property rights associated with the development of a small molecule drug that acts on the alpha-7 receptor."

Under its agreement with Innovative Metabolics, Critical Therapeutics is entitled to receive an initial license fee of $500,000 in cash plus a specified number of shares of preferred stock of Innovative Metabolics upon the completion of a financing by Innovative Metabolics and a one-time milestone payment of $1 million upon the achievement of all regulatory approvals. Critical Therapeutics also is entitled to receive royalties based on future sales and a percentage of payments received by Innovative Metabolics in connection with any sublicenses.

Innovative Metabolics is a privately held company founded by two of Critical Therapeutics' co-founders, Kevin J. Tracey, M.D. and H. Shaw Warren, M.D. In 2002, Dr. Tracey and a team of researchers at The Feinstein Institute for Medical Research (formerly the North Shore-Long Island Jewish Research Institute) discovered a pathway for the anti-inflammatory signal between the brain and major organs such as the heart, stomach, liver and small intestine. As part of this discovery, the Feinstein Institute secured intellectual property directed to both therapeutic and device approaches of stimulating this anti-inflammatory pathway. The discovery of this pathway was published in the December 2002 issue of Nature. Critical Therapeutics licensed patent rights related to the modulation of this pathway by pharmacologic agents and vagal nerve stimulation from the Feinstein Institute in 2003.

"Since Kevin's initial discovery, we have made great strides in understanding this novel anti-inflammatory pathway," said Thomas. "Allowing Innovative Metabolics to further invest in the device opportunity may provide valuable insights into this pathway that can be leveraged in our alpha-7 nicotinic receptor program. Critical Therapeutics now has a lead small molecule candidate, which was discovered through our own medicinal chemistry efforts, entering toxicology studies. This candidate has shown anti-inflammatory effects in models of asthma and acute lung injury."

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 introducing 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 possible future payments to us under the license agreement with Innovative Metabolics; our development plans for our alpha-7 project; the potential role of the vagus nerve in regulating the body's inflammatory response; 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: the completion of the initial financing by Innovative Metabolics; future development and commercialization efforts by Innovative Metabolics of a device to stimulate the vagus nerve; 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 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:Jan 30, 2007
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