Healthcare Industry News: zileuton
News Release - September 25, 2007
Critical Therapeutics Highlights Near-Term Milestones to Drive Commercial Success and Clinical DevelopmentAt 2007 Analyst Day, Company Discusses ZYFLO CR(TM) Launch Strategy, R&D Programs and Provides Guidance on Key Financial Metrics
LEXINGTON, Mass.--(HSMN NewsFeed)--Critical Therapeutics, Inc. (Nasdaq: CRTX ) today hosted its 2007 Analyst Day at the Four Seasons Hotel in New York. During the event, the Company:
- announced its September 27, 2007 U.S. launch date for ZYFLO CR(TM) (zileuton) extended-release tablets;
- updated analysts and investors on its ZYFLO CR launch strategy and co-promotion partnership with Dey, L.P. (DEY);
- reviewed the Company's three clinical development programs and its two novel drug candidates in preclinical development programs; and
- provided certain operational and financial guidance for 2007.
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 (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," 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 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). "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 and the Cystic Fibrosis 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, Roslyn, NY; Clinical Professor of Medicine and Pharmacology, New York College of Osteopathic Medicine, 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 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."
Trevor Phillips, chief operating officer, 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. 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) 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.
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 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® (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® (zileuton tablets) 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.
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 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.
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 and emphysema.
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 (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. 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
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 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.
Perforomist(TM) is a trademark of Dey, L.P.
Source: Critical Therapeutics
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