February 11, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Rumors are flying that Intercept Pharmaceuticals Inc. might be the acquisition target by AstraZeneca plc … maybe.
Earlier rumors suggested that the New York, NY-based Intercept might have been the acquisition target of Dublin, Ireland-based Shire . Shire, however, is, after long months of courtship, acquiring Bannockburn, Ill.-based Baxalta .
The rumors also suggest that Intercept has teamed with CenterView Partners to consult on a potential merger. CenterView was involved recently with Shire’s acquisition of Dyax Corp , as well as Celgene ’s merger of Receptos, Inc.
In December 2015, Intercept announced that the U.S. Food and Drug Administration (FDA) had extended the Prescription Drug User Fee Act (PDUFA) data for its Priority Review of obeticholic acid (OCA) in primary biliary cirrhosis, which apparently was recently renamed primary biliary cholangitis (PBC). The original date was Feb. 29, 2016, and is now May 29, 2016. The FDA also scheduled an advisory committee meeting of April 7, 2016.
Intercept has had its ups and downs with OCA. In May, the company announced it had a new design for its Phase III trial of OCA for non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. At that time the stock fell 16 percent, likely because the clinical trial schedule was longer than expected.
Both the FDA and the European Medicines Agency advised a redesign, so as a result the REGENERATE Phase III trial was designed as a double-blind, placebo-controlled pivotal trial with enrollment of approximately 2,500 patients. In addition, it included a pre-planned interim histology analysis at the end of 72 weeks of treatment in about 1,400 patients.
There are currently no approved treatments for NASH and no history of large clinical trials involving treatment of NASH patients. Other companies working on NASH treatments include Gilead Sciences, Inc. , with Simtuzumab, and Tobira Therapeutics Inc. with cenicriviroc.
Intercept is currently trading for $91.39 per share. Shares traded on May 18, 2015 for $313.98, dropped to $179.70 on Aug. 24, 2015, and popped back to $205.97 on Nov. 10.
On Jan. 29, 2016, Trade-Ideas LLC suggested that Intercept was a candidate for the so-called “dead cat bounce,” which is “down big yesterday but up big today.” Trade-Ideas cited several factors, including “an average dollar-volume of $74.7 million,” the volume of trading on that day as 67,356, which was down 9.9 percent the day before and up 3.7 percent the next day.
At the same time, which was about two weeks ago, TheStreet Quant Ratings listed the company as “sell.” It cited several problems, including “unimpressive growth in net income, weak operating cash flow, generally disappointing historical performance in the stock itself and feeble growth in its earnings per share.”
Intercept will be presenting today at the LEERINK Partners 5th Annual Global Healthcare Conference. It will also participate in the RBC Healthcare Conference on Feb. 23, 2016 at 2:35 p.m. Eastern Time.
