Critical Therapeutics Announces Beckman Coulter Exercises Option to Continue HMGB1 Diagnostic Development.LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that Beckman Coulter This article needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. , Inc. has exercised its option to continue to license patent rights relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the use of High Mobility Group Box 1 (HMGB1) technology to develop an immunoassay Immunoassay An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus. 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 Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight 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 Frank Thomas may refer to:
Sepsis refers to a bacterial infection in the bloodstream or body tissues. This is a very broad term covering the presence of many types of microscopic disease-causing organisms. and septic shock Septic Shock Definition Septic shock is a potentially lethal drop in blood pressure due to the presence of bacteria in the blood. Description Septic shock is a possible consequence of bacteremia, or bacteria in the bloodstream. , as well as chronic inflammatory diseases, such as rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. ." 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 Cytokine Any of a group of soluble proteins that are released by a cell to send messages which are delivered to the same cell (autocrine), an adjacent cell (paracrine), or a distant cell (endocrine). 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 Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. , 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 zileuton /zi·leu·ton/ (zi-loo´ton) an inhibitor of leukotriene formation, used as an antiasthmatic. Zileuton (Zyflo) tablets), which is marketed in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. 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 antibody therapy Clinical immunology Any therapeutic intervention in which a monoclonal or other concentrated antibody is used to manage a condition–eg, cancer or severe infection 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 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 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for the controlled-release formulation of zileuton (CR) and related discussions with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ; 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 Side effects Effects of a proposed project on other parts of the firm. 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 Form 10-Q See 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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