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Critical Therapeutics Highlights Near-Term Milestones to Drive Commercial Success and Clinical Development.


At 2007 Analyst Day, Company Discusses ZYFLO CR(TM) Launch Strategy, R&D Programs and Provides Guidance on Key Financial Metrics

LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) today hosted its 2007 Analyst Day at the Four Seasons Hotel in New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
. During the event, the Company:

1. announced its September 27, 2007 U.S. launch date for ZYFLO CR(TM) (zileuton zileuton /zi·leu·ton/ (zi-loo´ton) an inhibitor of leukotriene formation, used as an antiasthmatic.
Zileuton (Zyflo) 
) extended-release tablets;

2. updated analysts and investors on its ZYFLO CR launch strategy and co-promotion partnership with Dey, L.P. (DEY);

3. reviewed the Company's three clinical development programs and its two novel drug candidates in preclinical development programs; and

4. provided certain operational and financial guidance for 2007.

"We have several near-term milestones on the horizon, including the launch of two new products that position us for success and provide the momentum to drive long-term value for shareholders," Frank Thomas, president and chief executive officer of Critical Therapeutics, told Analyst Day attendees.

On September 27, 2007, Critical Therapeutics and its co-promotion partner, DEY, will commercially launch ZYFLO CR in the U.S. The companies expect to follow the launch of ZYLFO CR with the upcoming launch later this fall of Perforomist[TM] (formoterol fumurate) Inhalation Solution, DEY's new treatment for chronic obstructive pulmonary disease chronic obstructive pulmonary disease
n. Abbr. COPD
A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced.
 (COPD COPD chronic obstructive pulmonary disease.

COPD
abbr.
chronic obstructive pulmonary disease


Chronic obstructive pulmonary disease (COPD) 
).

"We are complementing the commercial launch of these products with zileuton-associated clinical development programs and earlier product development programs centered on controlling the production of potent inflammatory mediators that play a key role in regulating the body's immune system immune system

Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders.
," Thomas said. "We are excited about the progress we are making in our clinical development of an injectable formulation of zileuton for adjunctive use in acute asthma exacerbations and the development of a new oral formulation through our R(+) zileuton isomer isomer (ī`səmər), in chemistry, one of two or more compounds having the same molecular formula but different structures (arrangements of atoms in the molecule). Isomerism is the occurrence of such compounds.  program."

The Analyst Day featured a panel session with three expert respiratory physicians:

* Allan T. Luskin, M.D., Clinical Associate Professor of Medicine, University of Wisconsin; Director of Respiratory Institute, Dean Medical Center, Madison, Wisconsin, addressed the prevalence of asthma, which continues to grow at a rapid pace. Dr. Luskin highlighted the inclusion of zileuton in new guidelines from the National Asthma Education and Prevention Program (NAEPP NAEPP National Asthma Education and Prevention Program ). "At least one-third of asthma patients' medications do not provide them with the necessary relief from their symptoms," said Dr. Luskin. "The new NAEPP guidelines, which now recommend zileuton as a therapeutic alternative, will be widely distributed amongst leading respiratory specialists and will incorporate new treatment options, which may improve clinical control for asthma patients."

* Bradley E. Chipps, M.D., Medical Director of Respiratory Therapy respiratory therapy

Medical profession concerned with assisting the respiratory function of individuals who have severe lung disorders. Practices include suctioning to clear secretions from the airway, use of aerosol mists (sometimes medicated) or gases to ease breathing,
 and the Cystic Fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males.  Center, Sutter Medical Center; Capital Allergy and Respiratory Disease Center, Sacramento, California, discussed the importance of ZYFLO CR as a new treatment option for asthma patients. "This new treatment provides another therapeutic option for patients whose asthma symptoms are still uncontrolled despite their current therapies," he said.

* Philip Marcus, M.D., MPH, Chief, Division of Pulmonary and Critical Care Medicine, St. Francis Hospital St. Francis Hospital may refer to:
  • St. Francis Hospital — Wilmington, Delaware
  • St. Francis Hospital — Columbus, Georgia
  • St. Francis Hospital — Greenville, South Carolina
  • St. Francis Hospital — Memphis, Tennessee
  • St.
, Roslyn, NY; Clinical Professor of Medicine and Pharmacology, New York College of Osteopathic Medicine New York College of Osteopathic Medicine (NYCOM) is an osteopathic medical institution located in Old Westbury, Long Island, NY. Established in 1977, NYCOM is a fully accredited medical institution that boasts a long list of rotational sites for its medical students. , described his personal experience with a patient whose symptoms improved after four months on ZYFLO. "The patient is eagerly awaiting the launch of ZYFLO CR," Dr. Marcus said.

ZYFLO CR Launch

ZYFLO CR will be commercially launched nationwide on Thursday, September 27, 2007, with a combined sales force of 240 sales representatives calling on more than 18,000 allergists, pulmonologists and primary care physicians. Roger Heerman, vice president of sales and marketing, told the investment community, "We are excited to offer a twice-daily dosing regimen of ZYFLO CR for patients. In addition to a large and experienced specialty-focused sales team, ZYFLO CR will be supported by new branding designed to highlight the drug's unique mechanism of action."

R&D Pipeline

Trevor Phillips, chief operating officer Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
, provided attendees with an overview of the Company's clinical programs and pre-clinical pipeline. "In the coming weeks, we will have three clinical trials underway and two compounds in late pre-clinical development. We believe these programs have the potential to achieve important milestones for investors over the next 12 to 18 months."

Highlights from these programs include:

* Phase IV trial of ZYFLO CR in asthma patients on inhaled corticosteroids Corticosteroids, Inhaled Definition

Inhaled corticosteroids are glucocorticoids (a class of steroid hormones that are synthesized by the adrenal cortex and have anti-inflammatory activity) formulated to be used in the respiratory tract and lungs.
. Results from this trial are expected to be available in late 2008;

* Phase I trial of R(+) zileuton isomer. Results from this trial are expected in the first quarter of 2008;

* Phase II trial of zileuton injection for adjunctive use in acute exacerbations of asthma. Results from this trial are expected in the third quarter of 2008;

* Alpha-7 agonist program. A lead compound has been selected for further development. The Company expects to conduct toxicology studies on this compound in the first half of 2008 and submit an Investigational New Drug Application with the U.S. Food and Drug Administration (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.
) in the second half of 2008; and

* HMGB1 Antibody. In collaboration with MedImmune, Inc., the selection of a clinical candidate is expected by early 2008.

Financial Guidance

Tucker Kelly, chief financial officer and senior vice president of finance and corporate development, reviewed the terms of the Company's co-promotion agreement with DEY and reiterated full year 2007 net cash expenditure guidance of between $23 million and $25 million.

Presentation slides from the event are available in the Analyst Day section of the Company's Investor Relations Investor relations

The process by which the corporation communicates with its investors.
 website at www.crtx.com.

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 CR[TM] (zileuton) extended-release tablets and ZYFLO[R] (zileuton tablets). Critical Therapeutics is working to develop products for adjunctive use in 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.

About ZYFLO and ZYFLO CR

ZYFLO CR[TM] and ZYFLO[R] (zileuton tablets) are the only FDA-approved leukotriene leukotriene /leu·ko·tri·ene/ (-tri´en) any of a group of biologically active compounds derived from arachidonic acid that function as regulators of allergic and inflammatory reactions.  synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR and ZYFLO are not indicated for use in the reversal of bronchospasm bronchospasm /bron·cho·spasm/ (brong´ko-spazm) bronchial spasm; spasmodic contraction of the smooth muscle of the bronchi, as in asthma.

bron·cho·spasm
n.
 in acute asthma attacks, but can be continued during acute exacerbations of asthma. Leukotrienes Leukotrienes
A class of small molecules produced by cells in response to allergen exposure; they contribute to allergy and asthma symptoms.

Mentioned in: Leukotriene Inhibitors

leukotrienes
 are inflammatory mediators in asthma that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion.

The recommended dose of ZYFLO CR is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. The recommended dose of ZYFLO is one 600 mg immediate-release tablet four times a day for a total daily dose of 2400 mg.

ZYFLO CR and ZYFLO are contraindicated in patients with active liver disease Liver Disease Definition

Liver disease is a general term for any damage that reduces the functioning of the liver.
Description

The liver is a large, solid organ located in the upper right-hand side of the abdomen.
 or transaminase transaminase /trans·am·i·nase/ (-am´i-nas) aminotransferase.

trans·am·i·nase
n.
See aminotransferase.
 elevations greater than or equal to three times the upper limit of normal. A small percentage of patients treated with ZYFLO CR (2.5%) and ZYFLO (1.9%) in placebo-controlled trials showed an increased release of a liver enzyme known as ALT and bilirubin Bilirubin

The predominant orange pigment of bile. It is the major metabolic breakdown product of heme, the prosthetic group of hemoglobin in red blood cells, and other chromoproteins such as myoglobin, cytochrome, and catalase.
 (an orange or yellowish pigment in bile). As a result, the level of liver enzymes in patients treated with ZYFLO CR and ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO CR and ZYFLO and repeat the test on a regular basis while patients are on the medication. Patients taking ZYFLO CR and theophylline theophylline /the·oph·yl·line/ (the-of´i-lin) a xanthine derivative found in tea leaves and prepared synthetically; its salts and derivatives act as smooth muscle relaxants, central nervous system and cardiac muscle stimulants, and  should reduce the theophylline dose by 50%. Patients taking ZYFLO CR and propranolol propranolol /pro·pran·o·lol/ (-pran´o-lol) a ß, used as the hydrochloride salt in the treatment and prophylaxis of certain cardiac disorders, the treatment of tremors and of inoperable pheochromocytoma, and the prophylaxis of migraine.  or warfarin warfarin (wôr`fərĭn), anticoagulant used to treat blood clots. In large doses it causes bleeding. Warfarin, mixed with bait, is used in rodent control.
warfarin

Anticoagulant drug, marketed as Coumadin.
 should be monitored and doses adjusted as appropriate. Most common side effects Side effects

Effects of a proposed project on other parts of the firm.
 associated with the use of ZYFLO CR and ZYFLO are sinusitis sinusitis

Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise.
, nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea, respectively.

For full prescribing information for ZYFLO CR, please visit www.zyflocr.com or call the Company's toll free telephone number at 1-866-835-8216 to request medical information.

For full prescribing information for ZYFLO, please visit www.zyflo.com or call the Company's toll free telephone number at 1-866-835-8216 to request medical information.

About Perforomist

Perforomist[TM] Inhalation Solution is indicated for the long-term, twice- daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis chronic bronchitis
n.
Inflammation of the bronchial mucous membrane, characterized by cough, hypersecretion of mucus, and expectoration of sputum over a long period of time and associated with increased vulnerability to bronchial infection.
 and emphysema emphysema (ĕmfĭsē`mə), pathological or physiological enlargement or overdistention of the air sacs of the lungs. A major cause of pulmonary insufficiency in chronic cigarette smokers, emphysema is a progressive disease that commonly .

Important Safety Information

Perforomist[TM] belongs to a class of medications known as long-acting beta(2)-adrenergic agonists (LABAs). LABAs may increase the risk of asthma-related death. Data from a large placebo-controlled US study comparing the safety of another LABA LABA Libera Accademia Belle Arti
LABA Lubbock Area Baptist Association (Lubbock, TX)
LABA Long-Acting Beta-Agonist
LABA Latin American Business Association
LABA Leicestershire Asian Business Association (UK) 
 (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a LABA), the active ingredient in Perforomist[TM].

Perforomist[TM] should not be used in patients with acutely deteriorating COPD or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Perforomist[TM] should not be used with other medications containing LABAs. Do not use more than one nebule twice daily. Perforomist[TM] should be used with caution in patients with cardiovascular disorders. Perforomist[TM] is not a substitute for inhaled or oral corticosteroids Corticosteroids Definition

Corticosteroids are group of natural and synthetic analogues of the hormones secreted by the hypothalamic-anterior pituitary-adrenocortical (HPA) axis, more commonly referred to as the pituitary gland.
. The safety and efficacy of Perforomist[TM] in asthma has not been established. In COPD clinical trials, the most common adverse events reported with Perforomist[TM] were diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, statements regarding our commercial launch of ZYFLO CR, possible therapeutic benefits, market acceptance and future sales of ZYFLO CR and ZYFLO, the anticipated success of our co-promotion arrangements with DEY, the anticipated commercial launch of Perforomist, the progress and timing of our drug development programs and related trials, the efficacy of our drug candidates, our strategy, future operations, financial position, future revenues and projected costs, including our net cash expenditures for 2007, prospects, plans and objectives of management, 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: our ability to successfully market and sell ZYFLO CR and ZYFLO, including the success of our co-promotion arrangement with 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 safe and effective therapeutic products; adverse side effects experienced by patients taking ZYFLO CR or ZYFLO; our heavy dependence on the commercial success of ZYFLO CR; 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; the results of preclinical studies preclinical studies,
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research.
 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 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 CR and ZYFLO, our discoveries and our 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.

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([R]) is a registered trademark of Critical Therapeutics, Inc.

ZYFLO CR(TM) is a trademark of Critical Therapeutics, Inc.

Perforomist[TM] is a trademark of Dey, L.P.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved.

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Date:Sep 25, 2007
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