Healthcare Industry News:  SkyePharma 

Biopharmaceuticals Drug Delivery FDA

 News Release - July 31, 2006

Critical Therapeutics Submits New Drug Application for Controlled-Release Formulation of Zileuton To FDA

LEXINGTON, Mass.--(HSMN NewsFeed)--July 31, 2006--Critical Therapeutics, Inc. (Nasdaq: CRTX ) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the twice daily, controlled-release formulation of zileuton (zileuton CR). Zileuton CR is an investigational drug for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. Critical Therapeutics currently markets its asthma drug, ZYFLO® (zileuton tablets), the immediate-release formulation of zileuton, in the United States. ZYFLO is the only 5-lipoxygenase inhibitor approved for marketing by the FDA.

"Our NDA submission is a major milestone that moves us one-step closer to bringing zileuton CR to market," said Frank Thomas, President of Critical Therapeutics. "We believe the twice daily dosing regimen of zileuton CR will provide a more convenient option for patients than the current four-times-a-day dosing regimen of ZYFLO and consequently should improve patient compliance and expand product use, if approved by the FDA."

The NDA includes results from two previously completed Phase III clinical trials that evaluated the safety and efficacy of zileuton CR in 818 asthma patients. The NDA also includes results from three pharmacokinetic studies previously completed by Critical Therapeutics. Pending FDA approval of the NDA, the Company expects to launch zileuton CR in the second half of 2007.

"As part of our commercialization strategy for zileuton CR, we also are preparing our first Phase IIIb clinical trial, which is designed to help identify specific patient types or subgroups that could benefit most from treatment with zileuton CR beyond current standard-of-care," added Thomas. "To complement zileuton CR, we are developing an intravenous formulation of zileuton for potential use in emergency room and urgent care settings for patients experiencing acute exacerbations of asthma."

The controlled-release formulation of zileuton utilizes SkyePharma PLC's Geomatrix® technology. Critical Therapeutics entered in to an agreement in December 2003 with SkyePharma, through its subsidiary Jagotec, under which SkyePharma would manufacture zileuton CR for clinical trials, regulatory review and commercial sale.

According to the American Lung Association, approximately 20 million Americans have asthma, a chronic inflammatory disorder that occurs when the walls of the bronchial tubes become inflamed, causing the muscles to constrict and extra mucus to be produced. The Mayo Clinic notes that asthma can lead to a broad range of symptoms such as difficulty breathing, wheezing, chest tightness, and coughing, and in some cases, breathing may become so difficult that a flare-up may become life-threatening if not properly managed.

About Zileuton/ZYFLO

ZYFLO® (zileuton tablets) is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton inhibits 5-lipoxygenase (5-LO), an enzyme that catalyzes the formation of leukotrienes from arachidonic acid. 5-LO is the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. ZYFLO is the only 5-LO inhibitor approved for marketing by the U.S. Food and Drug Administration.

ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Mild to moderate side effects associated with the use of ZYFLO are abdominal pain, upset stomach and nausea. A small percentage of patients treated with ZYFLO show an increased release of a liver enzyme known as ALT. As a result, the level of liver enzymes in patients treated with ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO and repeat the test on a regular basis while patients are on the medication. ZYFLO is contraindicated in patients with active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal.

For full prescribing information, please visit www.crtx.com/pat_pi.html or call the Company's toll free telephone number 1-866-835-8216 to request medical information.

About Critical Therapeutics

Critical Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to the asthma drug ZYFLO® (zileuton tablets), as well as other formulations of zileuton. ZYFLO is the only 5-lipoxygenase inhibitor approved for marketing by the U.S. Food and Drug Administration. The Company's commercialization efforts for ZYFLO are carried out by its specialty sales force. Critical Therapeutics also is developing treatments directed toward the severe inflammatory response in acute diseases and conditions that lead to admission to the emergency room or intensive care unit, and acute exacerbations of other chronic diseases that frequently lead to hospitalization. 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 convenience and therapeutic benefits of zileuton CR and the expected patient compliance and product use; our ability to rely on historical data in seeking marketing approval for zileuton CR; the sufficiency and acceptability of the results of the zileuton CR pharmacokinetic studies and Phase III clinical trials for FDA purposes; the expected timing and outcome of the NDA submission for zileuton CR and related discussions with the FDA; the expected commercial launch date for zileuton CR; the progress and timing of our drug development programs and related trials; the efficacy of our drug candidates; the 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 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 timing and success of submission, acceptance and approval of our regulatory filings, including, without limitation, the NDA submission for zileuton CR; conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; 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 transition our management team effectively; our ability to successfully market and sell ZYFLO and, if approved, zileuton CR; our ability to maintain regulatory approvals to market and sell ZYFLO; our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO and, if approved, zileuton CR; patient, physician and third-payer acceptance of ZYFLO and, if approved, zileuton CR as safe and effective therapeutic products; adverse side effects experienced by patients taking ZYFLO and, if approved, zileuton CR; our heavy dependence on the commercial success of ZYFLO and zileuton CR; our ability to transition our management team effectively; 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 drug candidates and our discoveries. 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 (SEC). 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 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.


Source: Critical Therapeutics

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