Our strategy is to develop and commercialize medicines to treat liver disease and associated fibrotic and cirrhotic indications in areas of high unmet medical need. The key elements of our strategy are to:
Focus initial development of emricasan on the treatment of liver diseases with high unmet medical need and in small, identifiable and manageable patient populations.
We believe that by inhibiting the caspases responsible for inflammation and apoptosis in the liver, emricasan has the potential to stabilize and improve liver function and to slow liver disease progression in patients with liver cirrhosis. We are focusing our initial development of emricasan in high medical need patients with cirrhosis with varying degrees of liver function impairment. We expect the size and cost of the required clinical trials in these patients to be manageable for our company.
Pursue accelerated pathways for regulatory approval in the United States and the European Union.
Based on our initial development focus of emricasan on liver diseases with high unmet medical need in small, identifiable and manageable patient populations, we believe accelerated pathways for regulatory approval may be applicable in the United States and the EU. We plan to discuss our clinical development and regulatory strategy for emricasan with the U.S. Food and Drug Administration, or the FDA, and regulatory authorities in the EU.
Build our own sales and marketing capabilities to commercialize emricasan for indications that target small, identifiable and manageable patient populations in North America and Western Europe.
If emricasan is approved for one or more small, identifiable and manageable patient populations in North America and the EU, we intend to build our own commercial organization to market the product for these indications. Specifically, we plan to build a focused, specialized sales force to target the key physicians who treat these indications in these geographic locations, including hepatologists and other liver specialists in tertiary care and transplant centers.
Evaluate strategic partnerships to maximize the commercial potential of emricasan.
We plan to evaluate opportunities to partner emricasan with pharmaceutical companies that have established sales and marketing capabilities in regions outside of North America. We may also partner with a pharmaceutical company that has global capabilities to evaluate emricasan in larger patient populations with earlier stages of liver disease for which we believe it may also be effective, such as liver fibrosis from viral hepatitis, alcoholic hepatitis and NASH.