Critical Therapeutics and DEY, L.P. Enter into Co-Promotion Agreement for Respiratory Care Products
Wednesday March 14, 7:00 am ET
LEXINGTON, Mass. & NAPA, Calif.--(BUSINESS WIRE)--Critical Therapeutics, Inc. (Nasdaq: CRTX - News) 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." |
