- Johnson & Johnson has decided to stop developing one of its investigational treatments for the liver disease and refocus R&D investments toward hepatitis B therapies, citing the large pool of effective hepatitis C drugs on the market.
- Ongoing Phase 2 studies evaluating JNJ-4178, a regimen that combines three different hepatitis C medications, will run through completion, but Janssen Pharmaceuticals Inc., the drugmaking arm of Johnson & Johnson, won't progress the treatment further.
- "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, Janssen's global therapeutic area head for infectious disease therapeutics, in a Monday statement.
Johnson & Johnson's exit from JNJ-4178 development is reflective of the larger challenges facing hepatitis C drugmakers. Not only is therapeutic area crowded — with nearly 20 treatments having locked down approval from the Food and Drug Administration — but the treatable population is also shrinking as medicines like Gilead Sciences Inc.'s Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) essentially cure many of the most easily reached patients.
"Today, people living with hepatitis C have a much more diverse range of therapies available following a wave of innovative treatments securing approval," Janssen said in the Sept. 11 statement. "For most, the standard of care for hepatitis C therapy has a duration of 8-12 weeks offering a cure to around 92-100% of people treated."
Sovaldi, above all other products, changed the paradigm of the hepatitis C space. The drug's curative power, which would later present problems for Gilead, helped it to quickly snag market share away from competitors and achieve mega blockbuster status shortly after its initial FDA approval in late 2013. Sovaldi was so successful, in fact, that it forced out other products, including telaprevir, a drug co-developed by Johnson & Johnson and Vertex Pharmaceuticals Inc.
Johnson & Johnson's main hepatitis drug, Olysio/Sovriad (simeprevir), has also struggled.
The newer generation NS3/4A protease inhibitor came to market around the same time as Sovaldi; and while it did well at first, raking in more than $2.3 billion in 2014, sales of the drug have since plummeted in the face of new competition.. Last year, for instance, simeprevir fetched a relatively paltry $106 million in sales. What's more, acquisitions, divestitures and competitor products relating to Johnson & Johnson's hepatitis C business negatively impacted operational growth of the company's pharmaceutical segment by 2.5%.
JNJ-4178 is a combination regimen made up of simeprevir, Achillion Pharmaceuticals Inc.'s ACH-3102 (also called odalasvir) and AL-355, an NS5B polymerase inhibitor developed under Janssen subsidiary Alios BioPharma Inc. The regimen has been under investigation across a handful of early- to mid-stage clinical trials.
Now, the company's focus is shifting to hepatitis B, a therapeutic area with far fewer FDA-approved medicines. The disease affects about 2 billion people worldwide and roughly 12 million in the U.S., according the Hepatitis B Foundation.
Per that decision, Janssen has terminated a licensing agreement with Achillion Pharmaceuticals for ACH-3102.
"We are disappointed by Janssen's decision to discontinue HCV development given the positive data presented in Phase 2a with JNJ-4178, demonstrating a 100% cure rate after only six weeks of therapy," Achillion's CEO Milind Deshpande said in a Sept 11 statement. "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."
Achillion's stock opened at $3.77 per share on Monday morning, down more than 23% from close of market Friday. Johnson & Johnson's investors, meanwhile, didn't seem particularly moved by the program shuttering. The company's shares opened at $131.37 apiece on Monday, up less than 1%.