Bristol-Myers Squibb Company (BMY) announced encouraging data from a phase III study (Hallmark-Dual: n>700) which evaluated the combination of daclatasvir (DCV: a NS5A inhibitor) and asunaprevir (ASV: a NS3 inhibitor) over 24 weeks in patients infected with genotype 1b version of hepatitis C virus (:HCV). The combination is an all-oral, interferon and ribavirin-free regimen.
The percentage of patients who achieved sustained virologic response at 12 weeks after the completion of the treatment (SVR12) by the combination constituted the primary end point of the multinational study. Data from the study revealed that 90% treatment naïve patients achieved SVR12. The primary objective was met by 82% patients who failed to respond to peginterferon/ribavirin therapy. Similarly, 82% patients, who could not tolerate peginterferon/ribavirin therapy, achieved SVR12. Moreover, SVR12 rates were found to be roughly similar in cirrhotic (84%) and non-cirrhotic (85%) patients.
Bristol-Myers said that data from the Hallmark-Dual study formed part of the package on the basis of which the company sought U.S. approval for the combination earlier in the week. We note that Bristol-Myers is looking to get DCV approved in the EU as well in combination with other agents for treating adults suffering from HCV with compensated liver disease, inclusive of genotypes 1, 2, 3, and 4. The application is under accelerated review in the EU.
Bristol-Myers is also looking to get the combination of DCV and ASV approved in Japan for treating adults suffering from genotype 1b version of HCV. The patients were either ineligible for or intolerant to interferon therapy or non-responders to the same. Data from the Hallmark-Dual study was comparable to the phase III study results on the cocktail therapy, which formed the basis of the submission of the marketing application in that country.
Bristol-Myers stated in its press release that HCV affects approximately 170 million patients worldwide with a significant number being affected by the disease in the EU alone. The prevalence of genotype 1b HCV patients is high in the EU.
Apart from Bristol-Myers, companies such as Gilead Sciences (GILD) and AbbVie (ABBV) are also developing all-oral, interferon and ribavirin-free HCV therapies.
Bristol-Myers currently carries a Zacks Rank #2 (Buy). Amgen (AMGN) is a better-ranked stock with a Zacks Rank #1 (Strong Buy).