Date: 2015-05-19
Type of information: Licensing agreement
Compound: hepatitis C virus (HCV) assets which include ACH-3102 (odalasvir), ACH-3422 and sovaprevir
Company: Janssen Pharmaceuticals, a J&J company (USA - NJ) Achillion Pharmaceuticals (USA - CT)
Therapeutic area: Infectious diseases
Type agreement: licensing development commercialisation
Action mechanism: direct-acting antiviral agent/nucleotide NS5B polymerase inhibitor/nonstructural protein 5A (NS5A) inhibitor/NS3/4A protease inhibitor. Odalasvir (also known as ACH-3102) is a structurally distinct, second-generation NS5A inhibitor, which achieved 100% SVR12 in a Phase 2 study of genotype 1 HCV patients treated for 6-weeks with ACH-3102+sofosbuvir. ACH-3422 is a novel nucleotide NS5B polymerase inhibitor, which was found to be safe and well tolerated in a proof-of-concept trial and demonstrated a 4.6 log10 reduction in viral load with the 700 mg dose after 14 days of treatment. Sovaprevir is a potent NS3/4A protease inhibitor that completed multiple Phase 2 trials and demonstrated robust SVR rates in HCV patients.
Disease: hepatitis C
Details: * On May 19, 2015, Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced that it has entered into an exclusive worldwide license and collaboration arrangement with Achillion Pharmaceuticals 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 FDA, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration. 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. The transactions are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.
Financial terms: 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.
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