DGAP-News

Sucampo Receives Notice that Second Indication for AMITIZA for Opioid-Induced Constipation Is Not Approved by Medicines and Healthcare Products Regulatory Agency in U.K.

DGAP-News: Sucampo Pharmaceuticals, Inc. /
Sucampo Receives Notice that Second Indication for AMITIZA for
Opioid-Induced Constipation Is Not Approved by Medicines and
Healthcare Products Regulatory Agency in U.K.

13.03.2014 / 01:00

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Sucampo Will Evaluate All Options for Path Forward

BETHESDA, Md., 2014-03-13 01:00 CET (GLOBE NEWSWIRE) --
Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP) today announced that
Sucampo Pharma Europe, Ltd., its wholly owned subsidiary, has received a notice
of refusal to grant a Type II variation for AMITIZA(r) (lubiprostone) 24 mcg for
opioid- induced constipation (OIC) from the Medicines and Healthcare Products
Regulatory Agency (MHRA) in the United Kingdom (U.K.). In 2012, the MHRA
approved AMITIZA for the treatment of chronic idiopathic constipation (CIC) and
associated symptoms in adults when response to diet and other
non-pharmacological measures (e.g., educational measures, physical activity)
are inappropriate. In 2013, the United States (U.S.) Food and Drug
Administration approved AMITIZA as the first and only oral medication for the
treatment of OIC in adult patients with chronic, non-cancer pain. Sucampo is
reviewing the variation assessment report (VAR) from the MHRA and intends to
explore all available options for a path forward.

Sucampo completed in 2013 a Type II variation submission to update the Summary
of Product Characteristics (SPC) for AMITIZA in the U.K. to include the
additional therapeutic indication of OIC in non-cancer pain. MHRA is of the
opinion that insufficient evidence of efficacy for the proposed OIC indication
had been presented. The MHRA stated in the VAR that the safety profile of
lubiprostone appears consistent with what is currently described in the SPC for
the approved indication in CIC.

'While we are disappointed with the MHRA decision, we believe in the potential
of AMITIZA to meet the unmet medical needs of OIC patients,' said Peter
Greenleaf, Sucampo's Chief Executive Officer. 'AMITIZA is an important
treatment option for patients on three continents, with more than 8 million
patients treated in its 8 years on the market. Backed by the approval of
AMITIZA for OIC in the United States in 2013, we remain fully committed to
making AMITIZA available for additional indications in the U.K. and in other
geographic markets around the world. Sucampo intends to work closely with the
MHRA to determine our path forward.'

While the MHRA application included data from the comprehensive, global,