This morning, biopharma company Achillion Pharma (ACHN 3.96, -0.95 -19.4%) gets slammed as news that the company will terminate its Worldwide Collaboration for Hepatitis C with Johnson & Johnson’s (JNJ 132.79, +1.81 +1.38%) Janssen Pharmaceuticals hits investors where they were not expecting it.
Today’s notice follows the decision by Janssen also announced today to discontinue the development of the investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct acting antivirals: AL-335, odalasvir and simeprevir.
Since entering into the Janssen license arrangement in 2015, ACHN has focused on and advanced multiple small molecule factor D inhibitors of the complement alternative pathway. The first oral factor D inhibitor to demonstrate complete suppression of the alternative pathway, ACH-4471, is now in development for PNH, as well as C3G and IC-MPGN.
Further, in August 2017, the company announced positive interim data from a phase 2 three-month, dose-ranging trial with ACH-4471 for patients with untreated PNH. In addition to its plans to continue this study of untreated PNH patients, ACHN anticipates initiating a second phase 2 study in PNH patients who sub-optimally respond to treatment with eculizamab, the current standard of care.
Also during the second half of 2017, ACHN anticipates initiating patient dosing in two phase 2 trials of ACH-4471 for patients with low C3 levels due to C3G or IC-MPGN. The first is an open-label, 14-day trial expected to enroll up to 10 patients, while the second is a placebo-controlled, double-blinded six-month trial expected to enroll 20 patients.
Current HepC treatments on the market directly competing with ACHN’s treatment include but are not limited to -- Epclusa and Harvoni (made by Gilead), Incivek (made by Vertex Pharma), Mavyret (made by Abbvie) and Victrelis (made by Merck).
The collaboration, which was first entered into on May 19, 2015, was meant to develop and commercialize one or more of ACHN's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir. Per the terms of the 2015 deal, ACHN would have granted Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of ACHN's HCV assets. Additionally, ACHN was eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. ACHN was also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen would have bene responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets.
In an equity deal, separate to the exclusive license and collaboratio agreement, Johnson & Johnson Innovation - JJDC, Inc. invested $225 million in ACHN and, in return, receive about 18.4 million newly issued, unregistered shares of ACHN at a price of $12.25 per share.