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Zileuton Shows Significant Benefit in Prevention and Chronic Treatment of Asthma
Apr 2, 2005 - 8:39:00 AM, Reviewed by: Dr.
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"ZYFLO is the only asthma treatment that blocks the activity of the enzyme responsible for producing an array of inflammatory mediators, most notably leukotrienes. We believe this novel mechanism will allow ZYFLO to occupy a unique position in the treatment of asthma."
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By Critical Therapeutics, Inc.,
Critical Therapeutics, Inc. (Nasdaq: CRTX), today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the Company's investigational asthma drug ZYFLO(R) Filmtab(R) (zileuton tablets). Approval of the sNDA would allow Critical Therapeutics to begin marketing its version of ZYFLO in the United States.
"This is an exciting event that moves us one step closer toward our goal of becoming a fully integrated biopharmaceutical company," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "We anticipate launching ZYFLO in the second half of 2005, contingent upon regulatory approval of our sNDA."
The FDA approved ZYFLO in 1996 for the prevention and chronic treatment of asthma in patients 12 years of age and older. Critical Therapeutics in-licensed worldwide rights to ZYFLO in March 2004 and to other formulations of zileuton for a range of inflammatory diseases and conditions in December 2003.
ZYFLO has been commercially unavailable since early 2004 when commercial supply was depleted. Critical Therapeutics is required to submit an sNDA for ZYFLO because it is changing the manufacturing process and transferring production of the zileuton active pharmaceutical ingredient and the tablet formulation to third-party sites.
"ZYFLO is the only asthma treatment that blocks the activity of the enzyme responsible for producing an array of inflammatory mediators, most notably leukotrienes," Dr. Rubin said. "We believe this novel mechanism will allow ZYFLO to occupy a unique position in the treatment of asthma."
Clinical supply of ZYFLO currently is available through an open-label Phase IIIb study for patients who previously used and benefited from ZYFLO and need it to control their asthma symptoms. For more information regarding the open-label study, please visit the related link.
ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. For full prescribing information, please visit the related link. 
- U.S. Food and Drug Administration (FDA)
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 is developing a sales and marketing infrastructure in connection with its in-licensed product, ZYFLO(R), a tablet formulation of zileuton. 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
Statements in this press release that are not strictly historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, which include statements with respect to the timing of commercial launch of ZYFLO, are subject to numerous risks and uncertainties that may cause actual events or results to differ materially from those set forth in the statements. No forward-looking statements can be guaranteed, and actual results may differ materially from those projected as a result of various important factors, including risks relating to: the results of clinical trials with respect to our products under development; the timing and success of submission, acceptance and approval of our regulatory filings, including the sNDA referred to in this press release; our heavy dependence on the commercial success of ZYFLO tablets and the controlled-release formulation of zileuton; 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 drug candidates and our discoveries. These and other risks are described in greater detail in the "Factors That May Affect Future Results" section of our Annual Report on Form 10-K and other filings that we periodically file 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. All forward-looking statements reflect our beliefs and expectations as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We anticipate that subsequent events and developments will cause our views 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.
ZYFLO(R) is a registered trademark of Critical Therapeutics, Inc. Filmtab(R) is a registered trademark of the Abbott Group of Companies.
Contacts
Critical Therapeutics, Inc.
Linda S. Lennox, 781-402-5708
Director, Corporate Communications
[email protected]
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