Janssen Drops Out of HCV Development for Hepatitis B

Johnson & Johnson pharmaceuticals company Janssen Sciences announced Monday a strategic decision to discontinue further development of the investigational hepatitis C (HCV) treatment JNJ-4178, a triple-combination drug of three direct acting antivirals (DAA).

The drug — an amalgamation of AL-335, odalasvir and simeprevir — was undergoing Phase II studies at the time of Janssen's decision. An increasing rate of available and effective therapies for HCV hitting the market played a role in Janssen's decision, according to the company.

Instead, the company's research and development work will turn to chronic hepatitis B (HBV), Lawrence M. Blatt, PhD, Janssen's Global Therapeutic Area Head of Infectious Disease Therapeutics, said.

"Our scientists are energized by this challenge and our research ambition is to achieve a functional cure of hepatitis B which affects over a quarter of a billion people globally," Blatt said. "At Janssen, we focus our research and development on areas of greatest unmet medical need where we can combine our excellent internal science with the best available external innovation to bring optimized solutions and maximum benefit to patients."

The move also comes to the detriment of collaborating company Achillion Pharmaceuticals, which was co-producing JNJ-4178 with Janssen. Milind Deshpande, PhD, president and CEO of Achillion, expressed disappointment with the discontinuation, noting that the drug had demonstrated 100% cure rate "after only 6 weeks of therapy" in its Phase II-A data.

"While we believe that patients worldwide would benefit from convenient, short-duration therapies like JNJ-4178, we remain fully focused on advancing our factor D portfolio of complement alternative pathway inhibitors in areas where patient needs are greatest, and using our strong balance sheet of almost $370 million in cash and cash equivalents at June 30, 2017 to do so," Deshpande said in a statement.

Ongoing studies of JNJ-4178 will be completed, but no additional development will be pursued, according to Janssen.

The abandoned pursuit of HCV therapies ends a near decade-long of notable involvement in the field by Janssen. Telaprevir (Incevo), the first protease inhbitor for HCV genotype 1 combination therapy treatment, was approved by the US Food and Drug Administration (FDA) in April 2011 after years of Janssen development and research.

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