- Looking to build their experience and footprint in the liver disease space, Allergan and Novartis have entered a new partnership that will pair a drug from each company in a mid-stage trial.
- The Phase 2b study will evaluate a multi-therapy comprised of Allergan's cenicriviroc, an anti-inflammatory, and Novartis' LJN452, a medication that promotes the creation of bile acids, which the body uses to break down sugars and fats. The companies plan to test the multi-therapy in patients with non-alcoholic steatohepatitis (NASH), a form of non-alcoholic fatty liver disease (NAFLD).
- Pinpointing the size of the NAFLD population is tricky because the illness often exhibits no symptoms. However, researchers estimate between 80 million and 100 million people in the U.S. have the disease, with about a fifth of those being NASH patients.
With such a potentially large patient population and no Food and Drug Administration-approved treatments for NASH, it's unsurprising that drugmakers are eager to get into this market. Return on investment is also promising, as the global NASH therapeutics market is slated to grow to $1.6 billion by 2020, according to a report from Allied Market Research.
Allergan and Novartis aren't heavyweights in the liver disease space, but they've been doubling down recently to change their standing.
Allergan, for example, acquired NASH-focused Tobira Therapeutics in November for $570 million upfront and more than $1 billion more in potential milestone payments. The transaction gave the Irish pharma access to cenicriviroc as well as another drug, evogliptin, which helps increase insulin levels.
On Novartis' end, the Swiss drugmaker has been developing farnesoid X receptor (FXR) agonists, including LJN452, and in December inked a co-development and licensing agreement with Conatus Pharmaceuticals for the small company's candidate emricasan, a caspase inhibitor under investigation as an anti-inflammatory for NASH patients with advanced liver scarring and cirrhosis.
Novartis paid $50 million upfront in the deal with Conatus. While financial terms of its deal with Allergan were not disclosed in an April 18 statement, it's clear that both companies are willing to drop considerable cash into fleshing out their NASH treatment offerings.
"Collaboration with companies like Novartis will help us improve our understanding of the disease and deliver effective, high-value medicines for NASH patients," David Nicholson, Allergan's head of R&D, said in an April 18 statement.
The collaboration should also help the companies keep pace with rival players.
In this year alone, Bristol-Myers Squibb inked a deal with Danish biotech Nordic Bioscience to produce new biomarkers for NASH diagnosis and monitoring, and Gilead's CEO John Milligan signaled his company's focus on developing treatments for the roughly 3 million end-stage NASH patients with fibrosis.
Investors have looked kindly on such news. In February, for instance, Intercept Pharmaceuticals' shares rose when the FDA halved the required patient enrollment for a Phase 3 study of the company's NASH drug, obeticholic acid.