Sucampo and Takeda win FDA approval for irritable bowel syndrome drug

Wed. October 21, 2009; Posted: 09:44 AM

Oct 21, 2009 (Datamonitor via COMTEX) -- SCMP | Quote | Chart | News | PowerRating -- Sucampo Pharmaceuticals, a specialty biopharmaceutical company, and Takeda Pharmaceutical Company and its wholly owned subsidiary, Takeda Pharmaceuticals North America, have reported that the FDA has approved Sucampo's supplemental new drug application or sNDA for Amitiza 8mcg capsules twice daily to treat irritable bowel syndrome with constipation in women 18 years of age or older.

As a result of this sNDA approval, Sucampo Pharmaceuticals will receive a development milestone payment of $50 million from Takeda in accordance with the collaboration and licensing agreement signed in October 2004 between Sucampo Pharmaceuticals and Takeda to jointly market Amitiza in the US and Canada.

The sNDA was based on a clinical study program that included two Phase III, multi-center, double-blinded, randomized, placebo-controlled trials involving 1,154 adults, followed by one long-term, open-labeled extension trial involving 476 adults diagnosed with irritable bowel syndrome with constipation (IBS-C).

Sucampo Pharmaceuticals is currently conducting additional trials with Amitiza, including a clinical study for treatment of constipation in pediatric patients; a clinical study of Amitiza in patients with hepatic impairment, and a full clinical development for the treatment of opioid-induced bowel dysfunction, with two pivotal Phase III efficacy and safety studies and one long-term safety study ongoing.

Yasuchika Hasegawa, president of Takeda, said: "Amitiza's approval for the IBS-C indication obtained by Sucampo Pharmaceuticals is important for Takeda since gastroenterology is one of the core therapeutic areas for our company. This additional indication for Amitiza will help Takeda further enhance our position in the US primary care and gastroenterology specialty markets."

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