After a summer of deals, Ipsen is closing out the year with one last hurrah. The rare-disease-focused biopharma will partner with Genfit on a liver disease drug in a tie up potentially worth a half-billion dollars over time.
The companies will partner on elafibranor, the once-failed nonalcoholic steatohepatitis (NASH) drug that is going through late-stage tests for primary biliary cholangitis (PBC), according to a Friday statement.
Ipsen will pay 120 million euros ($136 million) upfront with milestone payments up to 360 million euros ($407 million), for a total of 480 million euros ($543 million) possible. Ipsen will also become the proud owner of 8% of Genfit’s shares, making it one of the largest shareholders in the nuclear-receptor-based drug discovery company.
Elafibranor is currently working through phase 3 trials in PBC, a chronic disease that slowly destroys the bile ducts in the liver. Ipsen will gain a worldwide license to develop the therapy in this indication, except in China, Hong Kong, Taiwan and Macau, where Genfit has a previous licensing agreement with Terns Pharmaceuticals. A top-line readout from the trial is expected in early 2023, the companies said.
The drug was once thrown on to the scrapheap of NASH meds that have failed in the clinic, adding Genfit to the not-so-exclusive club of companies that have hit a dead end in this indication. They’re in good company—even major pharmaceutical companies such as Pfizer have been stymied by the disease, which causes fat to build up in the liver.
After the phase 3 NASH flop, Genfit pinned its hopes on the PBC indication back in October 2020. A trial called ELATIVE is ongoing to determine the safety and efficacy of elafibranor in 150 patients who haven't responded to other treatments. The therapy won a breakthrough tag from the FDA as well as orphan designations in the U.S. and EU. An earlier phase 3 trial found that patients taking elafibranor experienced significantly reduced levels of certain biomarkers that are hallmarks of PBC.
Ipsen CEO David Loew said the Genfit partnership will help bulk up his company’s pipeline. The biopharma has been on a deal spree this year, signing agreements with Exicure worth up to $1 billion, another with BAKX Therapeutics for $14.5 million and still another with IRLAB for up to $363 million.
Genfit, on the other hand, has been in need of a partner since the NASH debacle. The company was forced to split operations into two and ax 40% of its workforce.
CEO Pascal Prigent said the Ipsen deal will bring elafibranor closer to helping patients, but also should provide some value for shareholders.
“While we hope, above all, that this partnership with Ipsen will be a significant step towards having a positive impact on the lives of millions of patients suffering from life-threatening liver diseases, we also believe our shareholders will recognize the benefit offered by this collaboration model,” Prigent said.
The Ipsen deal will “reinforce GENFIT’s long-term financial visibility,” according to Prigent, and provide funding to advance the company’s pipeline. He also noted the deal could help “provide opportunities for targeted business development.”
On that note, Genfit will also announce today the licensing of a new molecule.