A drug being tested against a liver disease thought to affect millions of people continues to hold up in a large clinical trial, according to its developer, New Jersey-based Intercept Pharmaceuticals.
The trial has enrolled thousands of patients with nonalcoholic steatohepatitis, or NASH, a disease characterized by a buildup of fat in the liver that progressively scars the organ. NASH is often asymptomatic until later stages, making it more difficult to diagnose. Yet, this “silent” disease has become one of the leading causes for liver transplants in the U.S.
Drug companies large and small have been spent more than a decade trying to develop the first approved treatment for NASH. In that race, Intercept and its candidate, known as obeticholic acid or OCA for short, have held a leading position.
In early 2019, OCA became the first drug to succeed in a Phase 3 study of NASH patients. The trial, named REGENERATE, enrolled participants with moderate to severe liver scarring, and found that a significantly greater percentage of those given a high dose of Intercept’s drug — as opposed to a placebo — had their liver scarring improve without their NASH getting worse. READ MORE
By Jacob Bell
The company plans to pour more than $500 million in additional funds into its active pharmaceutical ingredient (API) plant in Raheen, Limerick County, the country’s Industrial Development Agency (IDA) said. The new funding brings the company’s total investment in the site to 927 million euros ($1 billion).
“If in 2005 someone told you that two-thirds of our industry would be driven on the R&D side by emerging biopharma—it would be unthinkable. If one were to project that trend forward, what it would suggest is that we could have a day when we do this talk, say in 2027 or 2028, where 80% of the industry’s pipeline is coming from emerging companies.”
The German healthcare and agrochemicals giant told Reuters that in future its pharma pipeline will focus on cardiovascular disease, neurology, rare diseases and immunology, while de-emphasizing women’s health, a field it first focused on with the acquisition of the former women’s health specialist Schering in 2006.