Enanta has discovered novel protease inhibitors for use against the hepatitis C virus (HCV). These protease inhibitors, developed through Enanta’s collaboration with AbbVie, include paritaprevir, part of AbbVie’s currently marketed HCV regimens, and glecaprevir, Enanta’s second protease inhibitor product, which AbbVie is developing as part of its investigational, pan-genotypic HCV regimen of glecaprevir/pibrentasvir now under regulatory review in the U.S., the E.U. and Japan. AbbVie anticipates that this combination, known as G/P, will be approved in the U.S. in August and will be commercialized in all of these jurisdictions in calendar 2017.
Paritaprevir, a Protease Inhibitor for HCV Infection
Paritaprevir is an NS3/4A protease inhibitor discovered during the ongoing collaboration between Enanta and AbbVie for HCV protease inhibitors and the first developed in AbbVie’s treatment regimens that include protease inhibitors.
Paritaprevir is one of the direct-acting-antivirals in VIEKIRA PAK and the other treatment regimens that AbbVie developed and has been marketing worldwide for HCV genotypes 1 and 4.
AbbVie is responsible for all worldwide commercialization of paritaprevir-containing treatment regimens for HCV.
Glecaprevir, Enanta’s Second HCV Protease Inhibitor
AbbVie is completing development of glecaprevir, the second protease inhibitor discovered within the Enanta-AbbVie collaboration.
In Phase 3 clinical studies, eight weeks of therapy with a fixed-dose, once daily, ribavirin-free combination of glecaprevir and pibrentasvir (G/P) demonstrated sustained virologic response (SVR) rates averaging 97.5% across all major genotypes (GT1-6) in patients without cirrhosis and who were new to treatment, who represent the majority of HCV patients.
In patients with compensated cirrhosis, SVR12 rates were achieved after 12 weeks of therapy. High SVR rates were also achieved in patients with limited treatment options, including 98% of patients in a study of those with severe chronic kidney disease (CKD).
In patients with challenging-to-treat genotype 3 chronic HCV infection with cirrhosis, 95% achieved SVR12 after 8 weeks of therapy.
Glecaprevir was designed to enable once-daily dosing without ritonavir or ribavirin. AbbVie has co-formulated it in a fixed-dose combination with AbbVie’s next-generation NS5A inhibitor, pibrentasvir (ABT-530). A Marketing Authorization Application (MAA) has been granted accelerated assessment by the European Medicines Agency, and New Drug Applications are undergoing priority review by the U.S. Food and Drug Administration and the Japanese Ministry of Health, Labour and Welfare.
Our HCV Opportunity
Enanta has used a successful partnership with AbbVie to compete in the highly competitive market for hepatitis C virus (HCV) treatments. Since 2006 we have worked with our partner AbbVie (the former research-based pharmaceutical business of Abbott Laboratories) to develop protease inhibitors to treat HCV infection. Enanta is eligible to receive annually tiered, per product royalties ranging from the low double digits up to twenty percent, or up to the high teens on a blended basis, based on the annual net sales of each product developed under the agreement. In addition, Enanta is eligible to earn up to a total of $80 million in commercialization regulatory approval milestones payments from AbbVie for G/P, a majority of which are anticipated in calendar 2017.
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