Pipeline updates are highly-awaited events in the
pharma/biotech sector as they play an important role in deciding
whether to invest in a particular company or not. These updates
provide information on experimental drugs.
) Amitiza was approved by the U.S. Food and Drug Administration
(FDA) in 2006 for chronic idiopathic constipation (CIC) in
adults. It gained FDA approval in 2008 for irritable bowel
syndrome with constipation (IBS-C) in women aged above 18
Furthermore, it gained FDA approval for opioid-induced
constipation (OIC) in Apr 2013. Amitiza is approved for chronic
constipation (CC) in Japan where it is marketed in collaboration
However, Sucampo recently announced that its New Drug
Application (NDA) for the liquid formulation of Amitiza will not
be filed in the second half of 2014.
The U.S. Food and Drug Administration (FDA) informed Sucampo
that the former would require additional data to characterize
pharmacokinetics (PK) of the new formulation.
Sucampo is developing Amitiza in collaboration with its
Takeda Pharmaceuticals Inc.
), which markets the drug in the U.S. A liquid formulation of
Amitiza is being developed for certain pediatric and long-term
Sucampo and Takeda also announced top-line results from a
pharmacodynamic, PK and tolerability study on a liquid
formulation of Amitiza in adults suffering from CIC.
The data from the study showed directional improvement in
spontaneous bowel movement (SBM) frequency in favor of liquid
formulation of Amitiza as compared to placebo.
Taking into consideration the results from the study and the
feedback from the FDA, Sucampo and Takeda are now assessing their
next steps including formulation modification. Both the companies
are also evaluating the potential impact of this delay to the
timing of initiation of the second pivotal trial in the phase III
program for pediatric functional constipation in children aged
six months to less than 6 years. The liquid formulation of
Amitiza would be required for this study.
We expect investor focus to remain on further updates on the
Sucampo carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank#1 (Strong Buy).
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