Achillion, J&J HCV Triple Combination Drug Data Presented
Zacks Investment Research | Sep 25, 2016 09:00PM ET
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) presented updated interim results from a phase II study on a triple combination of AL-335, odalasvir (also known as ACH-3102) and Johnson & Johnson’s (NYSE:JNJ) Olysio (simeprevir) at the European Association for the Study of the Liver (EASL) Special Conference in Paris, France.
The phase IIa study was designed to determine the pharmacokinetics, efficacy and safety of odalasvir and AL-335, with or without simeprevirfor, in the treatment of patients suffering from genotype 1 chronic hepatitis C virus (HCV) infection.
In Jun 2015, Achillion out-licensed its HCV portfolio to Johnson & Johnson. Under the agreement, Johnson & Johnson has global rights to develop and commercialize one or more of Achillion's lead HCV candidates, including ACH-3102, ACH-3422 and sovaprevir.
The phase II study is being conducted by Alios BioPharma, Inc., part of a Johnson & Johnson subsidiary, Janssen. Note that AL-335 is a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir is an HCV NS5A inhibitor and Olysio is an HCV NS3/4A protease inhibitor.
The study showed that 100% of the patients on the six-week arm as well as the eight-week arm, who were treated with the triple combination of once-daily (QD) AL-335 800mg and simeprevir (SMV) 75mg with 50mg every other day (QOD) of ODV, achieved a sustained viral response 12 weeks after the completion of treatment (SVR12).
According to the company’s press release, almost 150 million people are infected with HCV worldwide, including approximately 3 million people in the U.S. This provides a huge potential market for the HCV triple combination globally.
Achillion’s collaboration with Johnson & Johnson for the HCV portfolio makes sense given the latter’s expertise in development and commercialization capabilities. Moreover, the deal could see Achillion receiving up to $1.1 billion in the form of development, regulatory and sales milestone payments, apart from a separate equity investment. Achillion is also entitled to receive tiered royalties in the mid teens to low twenties on future worldwide sales. All development and commercialization costs will be borne by Johnson & Johnson.
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