Intercept Pharmaceuticals (ICPT) Receives Breakthrough Therapy Designation from FDA

Shares of Intercept Pharmaceuticals Inc. (ICPT) were up +57.31 or +33.58 percent to $228.00 per share in pre-market trading on Thursday, after the company announced late yesterday its investigational product, obeticholic acid (OCA) had received "breakthrough therapy designation" from the U.S. Food and Drug Administration (FDA) for the treating patients with nonalcoholic steatohepatitis (NASH). Intercept Pharmaceutical stock closed at $170.69 per share, up +1.13 or +0.67 percent in Thursday's regular trading session.

New York City based Intercept Pharmaceuticals is a biopharmaceutical company specializing in developing and commercializing new treatments for chronic liver disease, such as primary biliary cirrhosis.
The company's main product is obeticholic acid or OCA, a substance structurally akin to naturally occurring human bile acid. The drug, which is a first in its class, selectively binds and activates "farnesoid X receptors" or FXRs that the company believes has protective properties for the liver.

The FDA's "breakthrough therapy designation" - given to Intercept's OCA for the treatment of NASH - is a new drug designation created to speed up the availability of new treatment therapies for life threatening and other serious health conditions. Drugs which receive this designation must show evidence of significant improvement in patients on a clinically important endpoint versus other available therapies, or over results with a placebo if no other treatments exist.

The breakthrough designation was given to OCA after two placebo controlled Phase 2 clinical trials in 64 patients with nonalcoholic fatty liver disease or NAFLD, and a FLINT Phase 2 trial in 283 patients with NASH. The FLINT Phase 2 trial showed the impact of OCA treatment on fibrosis and liver histology with the results published in The Lancet in November of 2014.

Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept stated in a press release that, "We are very pleased to have received breakthrough therapy designation for NASH with liver fibrosis, as it will enable us to work closely with FDA to finalize the design of our Phase 3 program, this designation underscores a recognition of the urgent need to bring novel treatments to NASH patients who have developed liver fibrosis, which is expected to make this serious disease the leading cause for liver transplant in just the next few years. As a first-in-class FXR agonist, we believe OCA has the potential to be an important treatment option for patients with no currently approved medicines."

In addition to the FDA's breakthrough designation, OCA's effectiveness was the subject of an article published in the American Journal of Pathology last week. The article showed that the investigational drug could play an important role in combating bacterial translocation or BTL, a condition which is commonly associated with chronic liver disease such as NASH.

Intercept Pharmaceutical stock has been one of the most volatile stocks in recent memory, trading below $70 per share in December of 2013, the stock quintupled to $445 in January of 2014 when OCA trials had stopped due to favorable results in a FLINT trial. The stock has since sold off significantly, making a closing low of $137.69 on December 8th, 2014.

Other News About Intercept Pharmaceuticals
Gilead Sciences Inc To Challenge Intercept Pharmaceuticals Over NASH
Gilead paid $470 million for Phenex Pharmaceutical AG's liver disease program earlier this month.
Intercept Pharmaceuticals Inc Gets Outperform Rating By BMO Capital
Analyst puts a $515 per share price target on Intercept stock.

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Published on Jan 30, 2015
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2016. Content published with author's permission.

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