Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has entered into an exclusive worldwide license and collaboration arrangement with Achillion Pharmaceuticals, Inc. (Achillion) to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422 and sovaprevir.

A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that is planned to be explored will feature Achillion's ACH-3102, an NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the US Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration.

"Despite recent treatment advances, there remain significant unmet needs to effectively address the burden which hepatitis C inflicts on both patients and society. 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," said Lawrence M Blatt, Ph.D., global therapeutic area head, Janssen Infectious Diseases and Vaccines, and president and chief executive officer of Alios BioPharma, Inc.

Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of the licensed HCV assets. Achillion will be eligible to receive milestone payments based upon the achievement of specified development, regulatory and sales milestones and tiered royalties on future worldwide sales.

In addition, and separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation - JJDC, Inc. will make an equity investment in Achillion.

The transactions are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.

The goal of the Janssen hepatitis C virus (HCV) clinical development program is to provide physicians with multiple treatment options in order to offer patients the best possible chance at successful therapy. Ongoing studies focus on the investigation of the NS3/4A protease inhibitor simeprevir in a number of different treatment combinations and HCV patient populations, including those who are difficult to cure. Following the acquisition of Alios BioPharma by Johnson & Johnson in November 2014 the Janssen HCV pipeline also includes AL-335, a uridine based nucleotide analog in phase 1 development, and AL-516, a guanosine-based nucleotide analog NS5B polymerase inhibitor in pre-clinical development. These compounds are being developed with the express intent of targeting critical steps of the HCV virus replication cycle.