) have been on a rollercoaster ride this year due to mixed updates
on the company's lead pipeline candidate, obeticholic acid (OCA).
Shares of the company were hammered a week ago after a report from
The Street disclosed that the company had information about the
occurrence of abnormal cholesterol levels in its phase IIb study on
OCA when it came out with a press release on Jan 9, 2014. The trial
was sponsored and conducted by the National Institute of Diabetes
& Digestive & Kidney Diseases (NIDDK).
We remind investors that on Jan 9 Intercept Pharma had announced
that the FLINT (Farnesoid X Receptor Ligand Obeticholic Acid in
Nonalcoholic Steatohepatitis Treatment) trial on OCA was stopped
early after the study met its primary endpoint. The study was
evaluating the efficacy and safety of OCA for the treatment of
nonalcoholic steatohepatitis (NASH). Shares of Intercept Pharma had
skyrocketed 281% following the news.
However, the company did not disclose the fact that the NIDDK
terminated the FLINT study early partially due to the serious
safety issues. According to The Street article, the NIDDK had
informed the company about the disproportionate finding on lipid
abnormalities (increased total cholesterol with increased
low-density lipoprotein/LDL and decreased high-density
lipoprotein/HDL cholesterol), which Intercept Pharma withheld in
its press release.
Currently, we expect the shares to be positively impacted
following the U.S. Food and Drug Administration's (FDA) decision to
grant Fast Track status to OCA for treating patients suffering from
primary biliary cirrhosis (PBC). Shares of the biopharmaceutical
company were also positively impacted in March this year following
the news that OCA met the primary endpoint in a phase III study
(POISE) in PBC patients.
Intercept Pharma intends to complete its new drug application
(NDA) submission to the FDA for OCA in the PBC indication by the
first half of 2015. The submission will be based on data from the
POISE trial in addition to positive data from 2 phase II studies.
We believe Intercept Pharma stands a better chance of success with
OCA in the PBC indication than in the NASH indication. We expect
investor focus to remain on updates regarding OCA going
Intercept Pharma currently carries a Zacks Rank #3 (Hold).
) are better ranked in the health care space. While Allergan and
Gilead are Zacks Rank #1 (Strong Buy) stocks, Alexion holds a Zacks
Rank #2 (Buy).
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