Abbott and Enanta Pharmaceuticals announced that the companies have signed a worldwide agreement to develop and commercialize hepatitis C virus (HCV) NS3 and NS3/4A protease inhibitors. Enanta has discovered several HCV protease inhibitors that have demonstrated attractive efficacy and pharmacokinetic profiles in pre-clinical studies.
"Abbott's innovative work in the protease inhibitor field against the Human Immunodeficiency Virus (HIV) has provided the momentum and the foundation for our research interest in HCV infection," said John Leonard, M.D., vice president, Global Pharmaceutical Research and Development, Abbott. "Enanta has done compelling work in its HCV protease inhibitor program, and we look forward to working together on the advancement of this global programme."
"Abbott is a market leader in the field of antiviral therapies, and we have a shared vision and commitment to the discovery and development of promising HCV therapies that address this high unmet medical need globally," stated Jay R. Luly, Ph.D., president and CEO of Enanta Pharmaceuticals.
Under the terms of the agreement, Abbott gains worldwide access to Enanta's substantial intellectual property position for a variety of different types of compounds, which includes several issued US patents. Abbott also gains access to Enanta's drug discovery capabilities in the HCV NS3 and NS3/4A protease inhibitor field. The closing of the transaction is subject to antitrust clearance under the Hart-Scott-Rodino Act.
Upon closing, Enanta will receive an upfront payment of $57 million, which includes a cash payment and an equity investment. If all potential clinical and regulatory milestones are met, additional payments of up to $250 million will be made to Enanta, and further payments will be due if multiple products develop from the program. Enanta will receive double-digit royalties and holds an option to fund 40 percent of development costs and US commercialization efforts (sales and promotion costs) in exchange for a 40 per cent profit share in the United States on medicines from this alliance that result in commercial approval.
"Through this alliance, we will enhance our HCV protease inhibitor program and allow both companies to participate in the long-term value creation of these compounds by leveraging Enanta's core expertise in chemistry and drug discovery with Abbott's proven track-record in the discovery, development, and commercialization of antiviral therapies," stated Yujiro S. Hata, senior vice president of Business Development at Enanta Pharmaceuticals.
Hepatitis C is a liver disease affecting more than 170 million people worldwide. The virus is spread through direct contact with the blood of an infected person. Hepatitis C increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer, and death. Liver disease associated with HCV infection is growing rapidly, and current therapies only provide sustained benefit in about half of patients with the genotype 1 form of the virus. Specifically targeted antiviral therapies for HCV, such as NS3/4A protease inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.