Ocaliva OK'd; Will NASH Success, Acquisition Be Next For Intercept?
As expected, Intercept Pharmaceuticals Inc. was granted an accelerated approval for Ocaliva (obeticholic acid) as a treatment for primary biliary cholangitis. But the drug's potential in the much more lucrative indication of nonalcoholic steatohepatitis may be what piques the interests of larger pharmaceutical companies for a possible acquisition of the New York-based biotech.
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Intercept Not Changing NDA Refiling Plans After OCA Misses NASH Cirrhosis Endpoint
Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.
The NASH Pipeline: Replete With Targets And New Compounds
The numerous different targets of investigational drugs for the treatment of NASH suggest the jury is still out on which mechanism of action is most likely to prove effective against the condition. Ireland’s Afimmune is the latest company wanting to advance an investigational drug for the disorder into late-stage clinical studies.
Shire's Ornskov Maps Out Future Prospects Post- Baxalta Merger
Shire's Danish chief executive says completing the Baxalta merger will greatly boost the group's exposure to longer acting orphan drugs, bring critical mass and de-risk its current asset mix with new portfolio products; a view widely shared by investors and analysts.