Healthcare Industry News: zileuton
News Release - May 2, 2007
Critical Therapeutics' Co-Promotion Partner, DEY, L.P., Launches U.S. Sales and Marketing of ZYFLO(R) for AsthmaProduct's Sales Force Increases from 18 to 220 Representatives
LEXINGTON, Mass.--(HSMN NewsFeed)--Critical Therapeutics, Inc. (Nasdaq: CRTX ) announced today that Dey, L.P. (DEY), an affiliate of Merck KGaA in Germany, began promoting ZYFLO® (zileuton tablets), Critical Therapeutics' asthma drug, in the U.S. on April 30, 2007. The addition of the DEY sales force brings the total number of sales representatives promoting ZYFLO to approximately 220. The combined sales force is focusing primarily on respiratory specialists, such as allergists and pulmonologists, as well as certain targeted primary care physicians.
"The significant increase in the sales promotion effort behind ZYFLO should generate greater physician and patient awareness of the therapeutic benefits of our asthma treatment," said Frank Thomas, President and Chief Executive Officer of Critical Therapeutics. "At the same time, we expect ZYFLO to gain greater traction in the market as information about the product becomes widely available. The combined sales effort should allow us to reach a significant base of physicians who treat asthma patients."
In March 2007, Critical Therapeutics and DEY entered into an agreement for the joint promotion of ZYFLO and, if approved by the FDA, the controlled-release formulation of zileuton (zileuton CR). zileuton CR has a Prescription Drug User Fee Act (PDUFA) date of May 31, 2007. ZYFLO is the FDA-approved immediate-release formulation of zileuton, a four-times daily medication for asthma in patients 12 years of age and older. zileuton CR is a twice-daily formulation that, upon FDA approval, will be marketed for asthma patients 12 years of age and older. zileuton CR uses SkyePharma PLC's proprietary Geomatrix® drug delivery technology, which controls the amount, timing and location of drug released into the body.
About ZYFLO and zileuton
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, headquartered in Lexington, MA, is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to ZYFLO® (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 developing a twice daily, controlled-release formulation for the prevention and chronic treatment of asthma and an injectable 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. For more information, please visit www.crtx.com.
Critical Therapeutics' 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 therapeutic benefits, market acceptance and future sales of ZYFLO and, if approved, zileuton CR; the anticipated success of our co-promotion arrangements with DEY; the progress, timing and success of our regulatory filings, regulatory approvals and product launches, including for zileuton CR; 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 expected timing and outcome of the new drug application (NDA) for zileuton CR and related discussions with the FDA, including our ability to rely on historical data in the NDA and the sufficiency and acceptability of the results of pharmacokinetic studies of zileuton CR for FDA purposes; our ability to successfully market and sell ZYFLO and, if approved, zileuton CR, 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, and, if approved, zileuton CR; 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 maintain regulatory approvals to market and sell ZYFLO and, if approved, zileuton CR; our ability to successfully enter into additional strategic co-promotion, collaboration or licensing transactions on favorable terms, if at all; 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, zileuton CR, our discoveries and our drug candidates. These and other risks are described in greater detail in the "Risk Factors" section of our Annual Report on Form 10-K 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® is a registered trademark of Critical Therapeutics, Inc.
Source: Critical Therapeutics
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