Healthcare Industry News: Lipoxygenase
News Release - March 14, 2007
Critical Therapeutics and DEY, L.P. Enter into Co-Promotion Agreement for Respiratory Care Products
LEXINGTON, Mass. & NAPA, Calif.--(HSMN NewsFeed)--Critical Therapeutics, Inc. (Nasdaq: CRTX ) and DEY, L.P., an affiliate of Merck KGaA of Darmstadt, Germany, today announced the signing of a definitive co-promotion agreement that leverages the expertise of both companies in the U.S. respiratory care market.With a combined sales force of 240 representatives, DEY and Critical Therapeutics have agreed to jointly promote Critical Therapeutics' marketed asthma drug, ZYFLO® (zileuton tablets) and the twice daily, controlled-release formulation of zileuton (zileuton CR), pending regulatory approval by the U.S. Food and Drug Administration (FDA). In addition, Critical Therapeutics has agreed to co-promote DEY's clinical candidate for Chronic Obstructive Pulmonary Disease (COPD), if approved by the FDA. A New Drug Application (NDA) for DEY's COPD product candidate also is being reviewed by the FDA.
"DEY is an ideal co-promotion partner due to its broad coverage of respiratory physicians and established track record of success in the respiratory market," said Critical Therapeutics' President and Chief Executive Officer Frank Thomas. "Based on prescribing patterns, we believe that a universe of more than 15,000 physicians, including allergists, pulmonologists and primary care physicians across the country will drive the success of zileuton CR."
"The zileuton products expand our respiratory franchise and build on our presence in the asthma market, leveraging our core competencies and our relationships with key physicians," said J. Melville Engle, DEY's President and Chief Executive Officer. "We are excited to work with Critical Therapeutics to advance these products as we strive to improve patient outcomes and enhance quality of life."
Zileuton CR is being developed for asthma patients 12 years of age and older whose symptoms are not well controlled with currently available asthma medications. The FDA is reviewing the NDA for zileuton CR, which has a Prescription Drug User Fee Act (PDUFA) date of May 31, 2007. Product launch is scheduled for the second half of 2007, pending regulatory approval. Until then, DEY will co-promote ZYFLO, the FDA-approved immediate-release formulation of zileuton, a four-times daily medication for asthma in patients 12 years of age and older. Critical Therapeutics also has granted DEY the exclusive rights to negotiate an agreement for the development and commercialization of additional zileuton products and formulations for a specified period, further enhancing the potential of this strategic partnership.
"Our agreement with DEY has the potential to be a transforming event for Critical Therapeutics," Thomas said. "This transaction makes it possible for us to accomplish three of our major corporate goals at once. First, we immediately gain a co-promotion partner for ZYFLO and the support of more than 200 additional experienced sales representatives who will be able to transition to promoting zileuton CR once that product is approved. Second, DEY provides us with a second product to increase the efficiency of our sales force. And finally, the co-promotion agreement provides a non-dilutive source of capital to fund the Company into 2009, assuming regulatory approval and a successful launch of zileuton CR."
Critical Therapeutics' Conference Call Information
Critical Therapeutics will hold an audio webcast and conference call to discuss the Company's co-promotion agreement with DEY. Investors and other interested parties can access the call as follows:
Date: Wednesday, March 14, 2007
Time: 11:00 A.M. (Eastern Time)
Dial-in: (800) 822-4794 (U.S. and Canada) (913) 981-4912 (international)
One-week Replay: (888) 203-1112 (U.S. and Canada) (719) 457-0820 (international) Passcode: 2514975
Webcast Information: www.crtx.com
A live and archived audio webcast of the conference call also will be available on the "Investors" section of the Critical Therapeutics website. From the home page, click on "Investors" and then on "Webcasts & Presentations."
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 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.
About DEY, L.P.
DEY, L.P. is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases and respiratory-related allergies. Since 1978, patients have benefited from DEY's commitment to innovative and affordable health care solutions. The Web sites for DEY include www.dey.com, www.accuneb.com, www.curosurfusa.com, www.duoneb.com, www.epipen.com. DEY is an affiliate of Merck KGaA, Darmstadt, Germany.
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 the status of the NDA for zileuton CR, including the timing or outcome of the FDA's review of the NDA, payments that may become due under the co-promotion agreement with DEY, whether the co-promotion agreement will become effective, potential future sales of zileuton CR, the anticipated success of the co-promotion arrangement, the sufficiency of current funds 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 NDA for zileuton CR and related discussions with the FDA; 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; conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; 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 discoveries and 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.
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.
Source: Critical Therapeutics
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