J&J Terminates Hep C Collaboration with Achillion

On Sep. 11, 2017, Janssen Sciences Ireland UC, a Johnson & Johnson company, and Achillion Pharmaceuticals, announced the termination of a 2015 worldwide license and collaboration arrangement under which the two companies were developing a hepatitis C treatment. Janssen said in a company press release that it had made the strategic decision to discontinue further development of JNJ-4178, an investigational hepatitis C combination regimen of three direct-acting antivirals: AL-335, odalasvir, and simeprevir.

Ongoing Phase II studies with JNJ-4178 will be completed as planned, but there will be no additional development thereafter. Janssen made this decision in light of the increasing availability of a number of highly effective therapies addressing the medical need in hepatitis C.

The companies formed the license and collaboration agreement worth up to $905 million in May 2015 to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets. Under the agreement, Achillion would grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion was eligible to receive several payments based upon achievement of specified development, regulatory, and sales milestones, as well as tiered royalty percentages on future sales. Janssen was responsible for all development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets.

“Going forward, our hepatitis R&D efforts will focus on chronic hepatitis B, where a high unmet medical need still exists. 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,” said Lawrence Blatt, PhD, global therapeutic area head, Infectious Disease Therapeutics, Janssen, in a company press release. “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.”

"We are disappointed by Janssen's decision to discontinue HCV development given the positive data presented in [Phase IIa] with JNJ-41781, demonstrating a 100% cure rate after only six weeks of therapy," stated Milind Deshpande, PhD, president and CEO of Achillion, in that company’s release. "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."

Source: Johnson & Johnson, Achillion Pharmaceuticals