OSAKA, Japan and NEW YORK, March 30, 2011 /PRNewswire/ —
Dainippon Sumitomo Pharma Co, Ltd. (DSP) and Intercept
Pharmaceuticals, Inc. (Intercept) today announced that they have
entered into an exclusive licensing agreement for the development
and commercialization of Intercept’s first-in-class FXR agonist
obeticholic acid (OCA, also known as INT-747). DSP will advance OCA
in Japan and China for the treatment of chronic liver diseases,
with an initial focus on primary biliary cirrhosis (PBC) and
nonalcoholic steatohepatitis (NASH). Intercept is currently
preparing for the initiation of a Phase III PBC program in the US
and Europe and, under the company’s cooperative research and
development agreement (CRADA) with the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK), a large
placebo-controlled trial of OCA in NASH patients recently started
enrolling in the US.
Under the terms of the licensing agreement, Intercept will
receive an initial payment from DSP of $15 million and will be
eligible to receive approximately $300 million in additional
milestone payments associated with the successful development and
commercialization of OCA. Upon launch of OCA, Intercept will be
entitled to receive tiered double-digit royalties from DSP based on
sales in its territory. DSP has the exclusive option to add several
other Asian countries to its territory, including Korea and Taiwan,
and to pursue additional indications. DSP will be responsible for
the costs of developing and commercializing OCA in its
territory.
“OCA is an important strategic addition to our growing pipeline
of hepatology drugs and reflects DSP’s strong commitment to
specialty therapeutic areas,” said Masayo Tada, President and CEO
of DSP. “There is a very high unmet medical need in the hepatology
area in Asia and DSP’s marketed products SUMIFERON®, a natural
alpha interferon, and MIRIPLA®, a therapeutic agent for
hepatocellular carcinoma, benefit many thousands of
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