Biotech Values

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AbbVie Presents New Data for its Investigational Hepatitis C Treatment in Japanese Patients With and Without Cirrhosis
- New data from GIFT-I study presented at the Annual Meeting of the Japan Society of Hepatology

- Primary endpoint of 95 percent and secondary endpoint of 91 percent SVR12 achieved in genotype 1b hepatitis C virus infected Japanese patients without and with compensated cirrhosis, respectively(1)

- 98 percent SVR12 achieved in additional analysis of patients without cirrhosis receiving double-blind placebo for 12 weeks, followed by open-label therapy with AbbVie's investigational treatment(1)

- AbbVie's ribavirin-free treatment for genotype 1 hepatitis C Japanese patients consists of a 12-week, two direct-acting antiviral, fixed-dosed combination of paritaprevir/ritonavir with ombitasvir, dosed once daily.

AbbVie (NYSE: ABBV) presented new results from the Phase 3 GIFT-I study of its investigational, all-oral, interferon (IFN)- and ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.1 GIFT-I evaluated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected Japanese patients, with and without cirrhosis, who were either treatment-naïve or IFN (with or without RBV) treatment-experienced.1 The primary endpoint was achieved, demonstrating 95 percent (n=106/112) SVR12 in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b HCV infected Japanese patients who were eligible for therapy with IFN and had a high viral load.1 In study results related to the secondary endpoint, GT1b HCV patients with compensated cirrhosis achieved 91 percent (n=38/42) SVR12.1

In an additional intent-to-treat (ITT) analysis, SVR12 was achieved in 98 percent (n=104/106) of the GT1b HCV infected patients without cirrhosis (Arm B) who were randomized to initially receive double-blind placebo for 12 weeks, followed by open-label treatment with ombitasvir/paritaprevir/ritonavir.1 The ITT population included every patient that was randomized to placebo and received at least one dose of active, open-label study drug.




Enanta says may receive $30M milestone payment from AbbVie upon Japan approval.

In reference to the release of GIFT-1 study data, Enanta (ENTA) stated that upon commercialization regulatory approval [sic] in Japan of AbbVie's (ABBV) treatment regimen related to GIFT-1, Enanta will be entitled to a $30M milestone payment from AbbVie. In addition, Enanta will be eligible to receive annually tiered royalties, ranging from the low double digits up to 20%, on AbbVie’s aggregate net sales of all paritaprevir-containing regimens, including 45% of AbbVie’s worldwide net sales of any two direct-acting antivirals regimen...

http://www.prnewswire.com/news-releases/abbvie-presents-new-data-for-its-investigational-hepatitis-c-treatment-in-japanese-patients-with-and-without-cirrhosis-300088921.html