Upcoming AWS Coverage on Exelixis Post-Earnings Results

LONDON, UK / ACCESSWIRE / March 3, 2017 / Active Wall St. blog coverage looks at the headline from Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) as the Company announced on March 01, 2017, that UK's National Institute for Health and Care Excellence (NICE) an advisor to the National Health Service (NHS) has approved Ocaliva (obeticholic acid) for routine use in England, Wales, and Northern Ireland. Intercept received the NICE approval only two months after marketing authorization in the EU, one of the fastest approvals to date for an orphan medicine. Register with us now for your free membership and blog access at:

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One of Intercept Pharma's competitors within the Biotechnology space, Exelixis, Inc. (NASDAQ: EXEL), reported on February 27, 2017, financial results for Q4 and full year of 2016. AWS will be initiating a research report on Exelixis in the coming days.

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

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Ocaliva has been conditionally approved in the European Union 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. The NHS is expected to make Ocaliva available to patients with PBC within 90 days of NICE's final appraisal publication and Intercept will work with local reimbursement authorities to help ensure eligible patients obtain access. Intercept stated that the treatment was the first new medication for PBC in nearly 20 years.

What is Ocaliva?

Intercept's Ocaliva is a potent and selective agonist of the farnesoid X receptor (FXR), which is expressed at high levels in the liver and intestine and thought to be a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. In December 2016, Ocaliva received conditional marketing authorization in Europe based on efficacy and safety data derived from three randomized double-blind, placebo-controlled clinical trials evaluating the effect of Ocaliva on alkaline phosphatase (ALP), and bilirubin in patients with PBC. The marketing authorization was also supported by two clinical databases that include more than 10,000 patients from the Global PBC Study Group and UK-PBC Group, both independently confirming that achieving lower ALP and/or bilirubin levels is significantly correlated with increased transplant-free survival. In May 2016, the US Food and Drug Administration granted accelerated approval to Ocaliva for the treatment of PBC.

"This very rapid decision by NICE, one of the fastest approvals to date for an orphan medication is an important affirmation of the scientific innovation, clinical value and cost-effectiveness of Ocaliva by one of the most respected health technology assessment bodies," said Lisa Bright, Intercept's President, International, "We welcome NICE's decision to provide broad access to Ocaliva and we owe a tremendous debt to people living with PBC and the clinical groups who helped us to achieve this milestone for the PBC community."

About Primary Biliary Cholangitis

Primary biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver disease that puts patients at risk for 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. As per the official release, in the UK, the estimated prevalence of PBC is approximately 3.9 per 10,000 populations, equating to approximately 19,175 people in England.

UK's Role in PBC Research and Awareness

Intercept noted that patients and medical leaders in the UK have played a critical role in accelerating PBC research, innovation, and awareness globally. The UK-PBC Study Group, a research consortium funded by the UK government through the Medical Research Council and National Institute for Health Research, played a critical role in the development of Ocaliva and was one of two clinical databases to independently confirm that achieving lower ALP and/or bilirubin levels is significantly correlated with increased transplant-free survival.

Stock Performance

At the closing bell, on Thursday, March 02, 2017, Intercept Pharma's stock fell 1.84%, ending the trading session at $126.62. A total volume of 657.55 thousand shares were traded at the end of the day, which was higher than the 3-month average volume of 534.84 thousand shares. In the last month and previous three months, shares of the Company have rallied 15.37% and 21.23%, respectively. Moreover, the stock gained 16.54% since the start of the year. At Thursday's closing price, the stock's net capitalization stands at $3.06 billion.

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SOURCE: Active Wall Street