Healthcare Industry News: zileuton
News Release - September 27, 2007
Critical Therapeutics and Dey Launch Twice-Daily ZYFLO CR(TM) (Zileuton) Extended-Release Tablets240-person Sales Force Begins Rollout to 18,000 Respiratory Specialists and Primary Care Physicians Throughout the U.S.
LEXINGTON, Mass.--(HSMN NewsFeed)--Critical Therapeutics, Inc. (Nasdaq: CRTX ) and Dey, L.P. (DEY), today began the nationwide launch of ZYFLO CR(TM) (zileuton) extended-release tablets, a twice-daily medication for the prevention and chronic treatment of asthma in patients 12 years of age and older. With a combined 240-person U.S. sales force, Critical Therapeutics and DEY have begun promoting ZYFLO CR to a targeted group of approximately 18,000 allergists, pulmonologists and primary care physicians throughout the United States.
"We are excited that we are now able to offer doctors and their patients a twice-daily dosing regimen with a similar safety profile as ZYFLO® (zileuton tablets), our four-times-daily immediate-release formulation," said Frank Thomas, president and chief executive officer of Critical Therapeutics. "While asthma prevalence continues to rise, we are pleased that we can offer an asthma treatment with a unique mechanism of action. ZYFLO and ZYFLO CR are the only leukotriene synthesis inhibitors approved by the U.S. Food and Drug Administration (FDA). ZYFLO has already helped many patients better control their asthma symptoms and we look forward to seeing those positive outcomes continue as we bring ZYFLO CR to market."
The 2007 Guidelines for the Diagnosis and Management of Asthma, which were developed by the National Asthma Education and Prevention Program (NAEPP), recommend zileuton as a therapeutic alternative for patients as part of a step-approach to reducing asthma symptoms and preventing exacerbations. It is the first time zileuton has been separately recognized in the guidelines since the NAEPP was initiated in 1989.
"The potential benefit of zileuton to help control a patient's asthma is supported by its inclusion in the new NAEPP guidelines," Thomas said. "We expect the guidelines to help raise the profile of ZYFLO CR as a treatment option for the many patients whose symptoms are still uncontrolled, despite the current therapies they are taking."
"Asthma impacts millions of patients in a debilitating cycle of sleep disruption, interference with physical activity, absenteeism from work and school and frequent trips to the doctor's office," said Allan T. Luskin, M.D., associate professor of medicine at the University of Wisconsin. "As a novel leukotriene synthesis inhibitor, ZYFLO CR has the potential to help asthma patients improve their disease."
ZYFLO CR and ZYFLO are the only FDA-approved leukotriene 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 in acute asthma attacks, but can be continued during acute exacerbations of asthma. Leukotrienes are inflammatory mediators in asthma that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. ZYFLO CR uses SkyePharma PLC's (LSE: SKP ) proprietary Geomatrix® drug delivery technology, which controls the amount and rate of drug released into the body.
ZYFLO CR will be priced at a wholesale acquisition cost (WAC) of $244.00 per month. The drug will be supplied to pharmacies in bottles of 120 tablets, representing a one-month supply for an individual patient.
Asthma is a chronic inflammatory disorder affecting approximately 20 million Americans. Asthma occurs when the walls of the bronchial tubes become inflamed, causing the muscles to constrict and extra mucus to be produced. This can lead to a broad range of symptoms from minor wheezing to severe difficulty in breathing. In some cases, breathing becomes so difficult during a flare-up or "asthma attack" that symptoms can be life threatening if not properly managed.
About ZYFLO CR and ZYFLO
ZYFLO CR and ZYFLO are the only FDA-approved leukotriene 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 in acute asthma attacks. Therapy with ZYFLO CR and ZYFLO can be continued during acute exacerbations of asthma.
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 or transaminase 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 (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 should reduce the theophylline dose by 50%. Patients taking ZYFLO CR and propranolol or warfarin should be monitored and doses adjusted as appropriate. Most common side effects associated with the use of ZYFLO CR and ZYFLO are sinusitis, 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 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 1-866-835-8216 to request medical information.
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® (zileuton tablets). Critical Therapeutics is working to develop products for 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.
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, our strategy, future operations, financial position, future revenues and projected costs, 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: 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 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 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® is a registered trademark of Critical Therapeutics, Inc.
ZYFLO CR(TM) is a trademark of Critical Therapeutics, Inc.
GEOMATRIX® is a registered trademark of SkyePharma PLC.
Source: Critical Therapeutics
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