Regulatory briefs: Amitiza in Japan; Dificid in Canada; Eurartesim roll-out

Sucampo Pharmaceuticals (Nasdaq: SCMP) and Abbott Labs (NYSE: ABT) have received approval from the Ministry of Health, Labor and Welfare in Japan for Amitiza (lubiprostone), a prescription medicine for the treatment of chronic constipation (excluding constipation caused by organic diseases).

In 2009, Sucampo and Abbott Japan entered into a license, commercialization and supply agreement for Amitiza in Japan for an upfront payment of $10.0 million and additional development and commercialization milestones (The Pharma Letter March 2009). Sucampo submitted a marketing application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market AMITIZA in September 2010. The application included data from a Phase III efficacy trial in 124 Japanese patients as well as from a long-term open-label safety trial in 209 Japanese patients who received lubiprostone for up to 48 weeks. The application also included data from previous trials conducted in the USA, Canada and Europe.

Optimer’s Dificid cleared by Health Canada