Two Companies Enter into Hepatitis C Drug Development Deal

Achillion Pharmaceuticals has joined forces with Janssen Pharmaceuticals to develop a short-duration oral regimen to treat chronic hepatitis C, the companies announced.

Achillion Pharmaceuticals has joined forces with Janssen Pharmaceuticals to develop a short-duration oral regimen to treat chronic hepatitis C, the companies announced.

Both companies have entered into an exclusive worldwide license and collaboration arrangement to develop and commercialize one or more of Achillion’s lead hepatitis C treatments (currently named ACH-3102, ACH-3422) and sovaprevir, according to a release from Janssen, which is owned by Johnson & Johnson. The aim of the partnership will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of the hepatitis C virus, states a Janssen release.

"Despite recent treatment advances, there remain significant unmet needs to effectively address the burden which hepatitis C inflicts on both patients and society,” stated Lawrence M. Blatt, global therapeutic area head of Janssen Infectious Diseases and Vaccines. “Janssen is committed to optimizing outcomes and the new collaboration with Achillion offers the potential to develop a new, simplified treatment option for those affected by hepatitis C.”

The two companies aim to develop a drug or combination of drugs by 2018 that works for all genotypes of the hepatitis C virus and shortens treatment durations to six weeks, according to the Janssen release. Current approved hepatitis C treatments typically require patients to take medicine from a minimum of eight weeks (for some treatment-naïve patients) to 12 weeks, including Gilead Science’s Harvoni, a front runner in the hepatitis C drug market.

Achillion representatives said in a release that the agreement includes eligibility payments from Janssen of up to $1 billion that would be triggered based on achieving development, regulatory and sales milestones. Achillion also is eligible for royalty percentage payments based upon future worldwide sales. Janssen will pay the tab for development and commercialization of hepatitis C drugs that result from the collaboration, according to the release.

Sovaprevir, one of the three compounds involved in the collaboration, is a NS3/4A protease inhibitor that Achillion has been testing in clinical trials as treatment for hepatitis C. A year ago, the FDA partially lifted a clinical hold on the investigational drug, which allowed clinical trials of a once-daily dose to go forward but at the time the agency kept in place a hold on multiple dose studies related to elevated liver enzymes in trials with healthy subjects.

In addition, Phase 2 clinical trials are being conducted on ACH-3102, an NS5A inhibitor that the FDA granted fast track designation, according to the release. ACH-3422 is the third drug included in the agreement and is a NS5B polymerase inhibitor that is in early-stage trials for use in combination hepatitis C regimens.

For its part, Janssen is not new to the hepatitis C drug stage. It markets the drug simeprevir under the brand name Olysio, which is used in combination with other drugs for chronic treatment of the virus.

"We are excited to collaborate with Janssen for the worldwide development of our HCV (hepatitis C virus) assets in combination with their HCV portfolio,” Milind Deshpande, PhD, Achillion’s president and CEO, stated in the company release. “We believe that Janssen's renowned expertise in HCV development and commercialization enables a synergistic opportunity to rapidly advance our combined HCV assets toward the market while simultaneously achieving an optimized treatment regimen for all HCV patients.”