CRTX Critical Therapeutics S-1
We are a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products designed to regulate the inflammatory response associated with asthma and critical care diseases. We currently have one FDA-approved product, Zyflo, an immediate-release formulation of zileuton for asthma that, subject to FDA approval of new manufacturing sites, we expect to begin selling in the first half of 2005, as well as two additional formulations of zileuton in development. In addition, we have three programs directed at developing products to regulate the excessive inflammatory response that can damage vital internal organs and, in the most severe cases, result in multiple organ failure and death.
We acquired from Abbott Laboratories exclusive worldwide rights to develop and market Zyflo and other formulations of zileuton for multiple indications. In 1996, the FDA approved the immediate-release formulation of zileuton, which was sold by Abbott as Zyflo, for the prophylaxis and chronic treatment of asthma. In connection with our license from Abbott, we are changing the sites of manufacture of Zyflo from Abbott. As a result, we are required to submit an sNDA to the FDA to obtain approval of the new manufacturing sites before we can begin selling the product in the United States. We plan to submit this sNDA to the FDA in 2004. Subject to approval from the FDA, we expect to launch Zyflo for asthma in the United States in the first half of 2005. In addition, we expect to submit an NDA to the FDA in 2005 for a controlled-release formulation of zileuton based on Phase III clinical trials previously conducted by Abbott. Based on scientific evidence, clinical results and currently reported usage, we believe that Zyflo and the controlled-release formulations of zileuton may provide benefits for asthma patients and that we would be able to improve Zyflo’s market penetration through a targeted commercialization effort. We intend to expand the zileuton franchise through the development of a new intravenous formulation initially for hospital emergency room use and through the clinical development of intravenous and oral formulations for additional therapeutic indications, such as COPD.
We are also developing treatments directed toward the severe inflammatory response in acute diseases and conditions that lead to admission to the emergency room or intensive care unit, and acute exacerbations of other chronic diseases that frequently lead to hospitalization. Our programs target the cytokine cascade, which is the expression of cytokines and other inflammatory mediators that play a fundamental role in the inflammatory response. Our research and development efforts directed towards the inflammatory response include:
• a CTI-01 program directed towards the development of a small molecule product candidate that directly affects the release of cytokines through a number of different mechanisms;
• an HMGB1 program directed towards a newly-discovered pro-inflammatory cytokine, which is the subject of our exclusive license and collaboration agreement with MedImmune; and
• a cholinergic anti-inflammatory program directed towards the á-7 receptor, which we believe regulates the release of mediators of the inflammatory response, including TNFá, in response to an inflammatory stimulus. |
