Johnson & Johnson is hoping its $100 million deal with Theravance will serve as a replacement for Remicade which lost patent protection.
Earlier this month Janssen Pharmaceuticals and its parent company Johnson & Johnson Family of Companies forked over $100 million to Theravance Biopharma as part of a collaborative deal to develop a treatment for inflammatory bowel diseases. If the drug hits, some analysts predict that it could be used as a replacement treatment for Janssen’s Remicade, which lost patent protection.
Janssen and Theravance are teaming up to develop TD-1473, a first-in-class oral, gastrointestinal (GI) restricted pan-Janus kinase (JAK) inhibitor. Irritable Bowel Disease (IBD) includes Crohn’s disease and ulcerative colitis (UC), which Remicade is prescribed for, along with rheumatoid arthritis.
Writing in The Motley Fool this morning analyst Cory Renauer pondered if the deal with Theravance could possibly offset some of the revenue J&J is losing from Remicade now that it has lost patent protection. Sales of Remicade fell 9 percent to $6.3 billion last year, which Renauer said was largely due to the loss of patent protection and exclusivity. If TD-1473 hits though, Renauer said many IBD patients on Remicade could be convinced to switch to TD-1473, which would have patent protection. If TD-1473 is approved analysts have predicted it could easily become a blockbuster treatment, but could it generate numbers like Remicade has? Renauer seems to think so.
In his column, he noted that between UC and Crohn’s disease there are about 800,000 hospital visits each year in the United States. Remicade has been used on these patients, but it does require intravenous delivery, Renauer said. The Theravance drug TD-1473 is an oral treatment, which would give it a huge advantage over Remicade. In addition to its easy-to-swallow delivery TD-1473 could have some additional advantages over Remicade since that drug comes with a black box warning. The warning label, as Renauer notes, cautions prescribers and patients of an increased risk of deadly infections but also calls for a routine monitoring of patients for tuberculosis.
Theravance’s TD-1473 is currently in a Phase II clinical trial for Crohn’s disease and the company is initiating a Phase IIb/III trial in UC later this year. Once the Phase II is complete Janssen has the option to take over the development of TD-1473 in Crohn’s. When the deal was initially announced BioSpace reported Theravance will continue development of the drug in UC until the conclusion of the Phase IIb/III program.
Janssen and Theravance aren’t the only ones developing JAK1 inhibitors. In December AbbVie investigational JAK1-inhibitor upadacitinib yielded positive top-line results in a Phase III trial as a monotherapy for rheumatoid arthritis patients. The drug is also being developed for the treatment of IBD. However, AbbVie’s JAK1 inhibitor did have some safety concerns, particularly with patients who had pre-existing cardiovascular risk factors. Theravance’s JAK1 drug has so far not had similar issues. Renauer said the company “reported no evidence of the systemwide immune suppression that hounds existing IBD treatments.”
