Sucampo's NDA Gets Delayed - Analyst Blog

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.

Sucampo Pharma's SCMP 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 years.

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 with Abbott Laboratories ABT.

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 partner Takeda Pharmaceuticals Inc. (TKPYY), which markets the drug in the U.S. A liquid formulation of Amitiza is being developed for certain pediatric and long-term care patients.

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 NDA.

Sucampo carries a Zacks Rank #3 (Hold). Right now, Shire plc SHPG looks attractive with a Zacks Rank#1 (Strong Buy).