Upcoming AWS Coverage on Ascendis Pharma Post-Earnings Results

LONDON, UK / ACCESSWIRE / December 15, 2016 / Active Wall St. blog coverage looks at the headline from Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) as the Company announced on December 14th, 2016, that the European Commission (EC) has granted conditional approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

One of Intercept Pharma's competitors within the Biotechnology space, Ascendis Pharma A/S (NASDAQ: ASND), reported on November 20, 2016, its financial results for the three months ended September 30, 2016. AWS will be initiating a research report on Ascendis Pharma in the coming days.

Today, AWS is promoting its blog coverage on ICPT; touching on ASND. Get all of our free blog coverage and more by clicking on the links below:

http://www.activewallst.com/registration-3/?symbol=ICPT

http://www.activewallst.com/registration-3/?symbol=ASND

What is PBC?

PBC is a rare, autoimmune cholestatic liver disease that puts patients at risk of life-threatening complications. PBC is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population.

What is Ocaliva?

Ocaliva (obeticholic acid) is a potent and highly selective agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. In May 2016, the US Food and Drug Administration (FDA) granted accelerated approval to Ocaliva for the treatment of PBC.

"We are delighted to be introducing the first new therapeutic option for PBC in nearly 20 years in Europe where this disease is a major reason for liver failure and a leading cause of liver transplant in women," said Lisa Bright, Intercept Phama`s President, International, "Following approval in the US earlier this year, Ocaliva`s marketing authorization in Europe represents another big step in Intercept`s mission to provide patients with worldwide access to our innovative therapy. This great achievement will motivate us further to continue developing solutions that improve the lives of people with progressive non-viral liver diseases."

The Approval Details

The marketing authorization from EC allows Intercept Pharma to market Ocaliva in 28 countries that are member states of the European Union, as well as 3 additional European Economic Area member states. As conditions of the approval, Intercept Pharma is required to provide post-approval updates on safety and efficacy analyses for Ocaliva from the ongoing Phase 4 COBALT outcomes study and a short-term study in patients with hepatic impairment.

The approval for Intercept's Ocaliva was based on efficacy and safety data derived from three randomized double-blind, placebo-controlled clinical trials which evaluated the effect of Ocaliva on alkaline phosphatase (ALP) and bilirubin in patients with PBC. The data was also supported by two clinical databases that include more than 10,000 patients from the Global PBC Study Group and UK-PBC Group, with both the bodies independently confirming that achieving lower ALP and/or bilirubin levels is significantly correlated with increased transplant-free survival.

In the III stage of the POISE study, approximately 46% in the titration group treated with Ocaliva in combination with UDCA achieved the primary endpoint compared to 10% in the control group ((p<0.0001). Additionally, 77% of patients taking Ocaliva in combination with UDCA achieved a reduction of more than 15% in ALP at 12 months compared to 29% taking UDCA alone.

Intercept Pharma stated that the most commonly reported adverse reactions were pruritus (63%) and fatigue (22%). Adverse reactions leading to discontinuation were 1% in the Ocaliva titration arm and 11% in the Ocaliva 10 mg arm. The company noted that the majority of pruritus occurred within the first month of treatment and tended to resolve over time with continued dosing.

Stock Performance

At the closing bell, on Wednesday, December 14, 2016, Intercept Pharma's stock price dropped 3.88% to end the day at $104.32. A total volume of 464.62 thousand shares were exchanged during the session, which was above the 3-month average volume of 461.78 thousand shares. The stock currently has a market cap of $2.51 billion.

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SOURCE: Active Wall Street