| An SI Board Since August 2003 |
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MYOG |
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From the preliminary S-1
Myogen is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders. We believe that our advanced understanding of the biology of cardiovascular disease combined with our clinical development expertise in cardiovascular therapeutics provide us with the capability to discover novel therapies, as well as identify, license or acquire products that address serious, debilitating cardiovascular disorders that are not adequately treated with existing therapies. We currently market one product in Europe, Perfan I.V., for the treatment of acute decompensated heart failure, and we have three product candidates in late-stage clinical development: enoximone capsules for the treatment of chronic heart failure, ambrisentan for the treatment of pulmonary arterial hypertension and darusentan for the treatment of uncontrolled hypertension.
• Enoximone, a type-III selective phosphodiesterase inhibitor, is a positive inotropic agent that increases the force of contraction of the heart. The intravenous formulation of enoximone, Perfan I.V., is used for the treatment of acute decompensated heart failure. We are evaluating enoximone capsules, the oral formulation of enoximone, in three Phase III clinical trials for the long-term treatment of advanced chronic heart failure. We expect these trials will be fully enrolled by the end of this year and, if the trials progress as planned, we expect the patients will have completed treatment by the end of 2004. We believe that enoximone capsules have the potential to alleviate symptoms, reduce hospitalizations and improve quality of life for patients with advanced chronic heart failure.
• Ambrisentan, an ETA selective endothelin receptor antagonist, is a potent inhibitor of endothelin-induced vasoconstriction. We are developing ambrisentan as an oral therapy for patients with pulmonary arterial hypertension. Results of the blinded portion of a Phase II trial completed in June 2003 demonstrated that ambrisentan produced a statistically significant and clinically meaningful increase in the primary efficacy endpoint, exercise capacity as measured by a six-minute walk test. Ambrisentan also demonstrated a beneficial effect on pulmonary vascular hemodynamics and secondary endpoints such as the Borg Dyspnea Index, Subject Global Assessment and World Health Organization Functional Class, which are tests used by physicians to assess the severity of pulmonary arterial hypertension. The safety results demonstrated a low (1.6%) incidence of liver toxicity and no harmful interactions with other drugs, including anticoagulants. We plan to initiate our pivotal Phase III clinical evaluation of ambrisentan for the treatment of patients with moderate to severe pulmonary arterial hypertension in the first half of 2004.
• Darusentan, an ETA selective endothelin receptor antagonist, is a potent inhibitor of endothelin-induced vasoconstriction. We are developing darusentan as an oral therapy for patients with hypertension not adequately controlled by multiple other anti-hypertensive agents. Results from a Phase II trial conducted in patients with hypertension demonstrated that darusentan produced statistically significant and clinically meaningful decreases in both diastolic and systolic blood pressures. We plan to initiate our Phase IIb clinical evaluation of darusentan for the treatment of uncontrolled hypertension in patients with moderate to severe chronic kidney disease in 2004.
We also conduct a target and drug discovery research program focused on the development of disease-modifying drugs for the treatment of chronic heart failure and related cardiovascular disorders. Our research team and academic collaborators have discovered several key molecular defects that occur in a failing heart. We have validated several of these molecular defects as targets for drug discovery and we are now screening chemical libraries with high-throughput assays based on these targets.
Our goal is to create an integrated biopharmaceutical company focused on the discovery, development and commercialization of novel therapies that address the fundamental mechanisms involved in cardiovascular disease, with an initial focus on highly debilitating chronic conditions. Our strategy is to utilize our advanced understanding of the molecular biology and clinical medicine of cardiovascular disease to (i) complete the clinical development of, and obtain regulatory approvals for, enoximone capsules, ambrisentan and darusentan, (ii) identify and acquire additional clinical-stage compounds and (iii) discover and develop novel therapeutics which slow or reverse the progression of cardiovascular disease. In addition, we plan to develop our own sales and marketing capabilities focused on targeted markets and to enter into co-promotion partnerships with larger pharmaceutical or biotechnology companies when necessary to reach larger markets. Similarly, we intend to selectively enter into strategic research and development collaborations with other pharmaceutical or biotechnology companies to advance our research program.
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