Type of information: Exercise of an option agreement
Company: Novartis (Switzerland) Conatus Pharmaceuticals (USA - CA)
Therapeutic area: Hepatic diseases - Liver diseases
Type agreement: development - licensing - commercialisation
- caspase converting enzyme inhibitor. Emricasan is a first-in-class, orally active caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death, or apoptosis. In February 2016, the FDA granted Fast Track designation to the emricasan development program for the treatment of liver cirrhosis caused by NASH.
- Conatus is conducting three randomized, double-blind, placebo-controlled Phase 2b EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical trials designed to evaluate emricasan treatment in various NASH patient populations:
- - ENCORE-LF (for Liver Function), initiated in the second quarter of 2017, in approximately 210 patients with decompensated NASH cirrhosis, with top-line results expected in 2019;
- - ENCORE-NF (for NASH Fibrosis), initiated in the first quarter of 2016, in approximately 330 patients with NASH fibrosis, with top-line results expected in the first half of 2019; and
- - ENCORE-PH (for Portal Hypertension), initiated in the fourth quarter of 2016, in approximately 240 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension, with top-line results expected in 2018 followed by an integrated 6-month treatment extension period for clinical outcomes.
Disease: NASH (non-alcoholic steatohepatitis) and chronic liver diseases
- • On July 6, 2017, Conatus Pharmaceuticals announced that its exclusive license with Novartis for the global development and commercialization of emricasan has become effective under terms of the Option, Collaboration and License Agreement signed in December 2016. The license became effective on July 5, 2017, upon Conatus' receipt of a $7 million payment, which followed U.S. Federal Trade Commission review and expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to the agreement.
• On May 4, 2017, Novartis announced that it has notified Conatus Pharmaceuticals of its exercise of the option to an exclusive license for the global development and commercialization of emricasan, under the option, collaboration and license agreement signed with Conatus on December 19, 2016. The exercise of the option with Conatus and grant of exclusive license to Novartis will be effective upon receipt of all required anti-trust approvals and payment of $7 million option exercise fee to Conatus. This follows the initiation of the Phase IIb ENCORE-LF trial by Conatus evaluating emricasan in patients with decompensated liver cirrhosis caused by nonalcoholic steatohepatitis (NASH).
Novartis is developing Farnesoid X receptor (FXR) agonists for the treatment of chronic liver diseases. As part of this collaboration, Conatus will conduct multiple Phase IIb clinical trials with emricasan in NASH. If results are positive, Novartis would then conduct Phase III studies of emricasan as a single treatment as well as development of combination therapies with an FXR agonist. The most advanced Novartis investigational compounds, both non-bile acid FXR agonists, are in Phase II clinical trials. Both of these FXR agonists have received Fast Track designation from the FDA for NASH with liver fibrosis. In addition, the FDA has granted Fast Track designation for the development of emricasan in patients with NASH cirrhosis.
Recently, Novartis announced a clinical collaboration with Allergan to conduct a Phase IIb study, involving the combination of a Novartis FXR agonist,LJN452, and Allergan’s cenicriviroc for the treatment of NASH with liver fibrosis. Both collaborations with Conatus and Allergan continue to support the growing Novartis portfolio to develop new therapies in chronic liver diseases, including NASH.
• On December 19, 2016, Novartis announced the signing of an exclusive option, collaboration and license agreement with Conatus Pharmaceuticals, a biotechnology company focused on the development of novel medicines to treat liver disease. This agreement will enable Novartis and Conatus to jointly develop emricasan. This collaboration has the potential to expand treatment options for people in various stages of fatty liver disease, where no approved medicines currently exist.
Novartis is developing Farnesoid X receptor (FXR) agonists for the treatment of chronic liver diseases. As part of this collaboration, Conatus will conduct multiple Phase 2b clinical trials with emricasan in NASH. If concluded positively, Novartis would then conduct Phase 3 studies of emricasan as a single treatment and start development of combination therapies with an FXR agonist.
FXR agonists have been shown to address three of the most important aspects of NASH progression by reducing fat, inflammation and fibrosis in the liver. The most advanced Novartis investigational compound, a potent, non-bile acid FXR agonist, has recently received Fast Track designation from the FDA for NASH with liver fibrosis and is in a Phase 2 clinical trial.
Financial terms: Under the terms of this agreement, Novartis will make an upfront payment to Conatus of $ 50 million. Any additional exercise fee will be paid to Conatus following achievement of certain criteria as defined in the option, collaboration and license agreement, including required anti-trust approvals.