In late 2012 Sucampo Pharmaceuticals (NASDAQ: SCMP) received approval from the Food and Drug Administration (FDA) to expand upon its gastrointestinal drug -- AMITIZA -- to treat people with opioid-induced constipation (OIC) in the United States.
With increasing competition from other biotechnology companies, that approval is keeping the Bethesda-based drug developer ahead of them and profitable, with a net income posted in 3 out of the last 4 quarters of 2013, including the most recent fourth quarter.
Unfortunately the same submitted technical data to the FDA wasn’t enough to convince the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom. The company is trying to take AMITIZA for OIC full-global, but Sucampo’s European subsidiary (Sucampo Pharma Europe) received a notice of refusal to grant a Type II variation for AMITIZA for OIC, in the same way the drug is already expanded for marketing and use to treat opioid-induced constipation in the United States.
Sucampo said although the data submitted included studies of 1,300 patients across three Phase 3 trials conducted in 7 countries (including the U.K.), the MHRA only considered one of the studies pivotal. In Summary the MHRA is questioning the efficacy of the drug to treat OIC.
Sucampo is not giving up though, and as past events at the company will show, Sucampo is not afraid of a fight. "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."
Sucampo stock closed Wednesday positive at $8.32 a share, the stock is up 68 percent this year but is bound to take a hit after the release of the U.K. disapproval.