Critical Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of products for respiratory and inflammatory diseases.
On May 1, 2008, we signed a definitive merger agreement Cornerstone BioPharma Holdings, Inc., a privately-held company. Cornerstone is a specialty pharmaceutical company focused on developing and commercializing prescription medications for respiratory disorders. The stock-for-stock transaction is targeted to close in the fourth quarter of 2008.
We own worldwide rights to two FDA-approved drugs: twice-daily ZYFLO CR™ (zileuton) extended-release tablets and ZYFLO® (zileuton tablets), the four-times daily, immediate-release formulation of zileuton. ZYFLO CR and ZYFLO are the only FDA-approved leukotriene synthesis inhibitors approved 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.
We currently market ZYFLO CR together with our partner, Dey, L.P. (DEY), a subsidiary of Mylan Inc. ZYFLO CR was approved by the FDA on May 30, 2007 and Critical Therapeutics and DEY launched the product with a combined sales force of 240 representatives on September 27, 2007. We also co-promote DEY’s product Perforomist™ (formoterol fumarate) Inhalation Solution, which was approved by the FDA on May 11, 2007 for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD) and launched on October 8, 2007.
Please see full prescribing information for ZYFLO® (zileuton tablets).
Please see full prescribing information for ZYFLO CR™ (zileuton) extended-release tablets.
Please see full prescribing information for Perforomist™ (formoterol fumarate) Inhalation Solution.
We are also working to develop products for acute asthma attacks that lead patients to the emergency room and other urgent care settings. In addition, we are pursuing life cycle extension strategies designed to enhance the intellectual property position for our zileuton franchise.
In addition to our zileuton franchise, we have two novel pre-clinical programs directed at developing products to regulate excessive inflammatory responses. The first program is partnered with MedImmune, Inc. and is directed at designing and developing antibody therapeutics that can treat both chronic and severe acute inflammatory diseases in which the inflammatory cytokine, HMGB1, plays a role. The second program is directed at the discovery and development of small molecule anti-inflammatory products that harness the body’s powerful pathway to protect from pathologic inflammation by stimulating the alpha-7 nicotinic receptor on human inflammatory cells.
Our corporate headquarters is in Lexington, MA. |
