Sucampo Pharmaceuticals’ (SCMP) flagship product Amitiza (lubiprostone) is marketed for CIC (chronic idiopathic constipation), IBS-C (irritable bowel syndrome with constipation), and OIC (opioid-induced constipation). In the United States, Amitiza is marketed by Takeda Pharmaceuticals (TKPYY). Sucampo is responsible for its clinical development activities related to label expansion. Takeda holds the global commercialization rights for Amitiza except in Japan and China.
There are two categories in the chronic constipation market: generic laxatives and branded products. According to Sucampo, generic laxatives make up 80%–90% of the total prescription volume in the chronic constipation market. Branded products have slowly captured 10%–20% of that market.
Amitiza’s life cycle management
Sucampo Pharmaceuticals has granted licenses to commercialize a generic or authorized generic of Amitiza in the United States to Par Pharmaceutical and Dr. Reddy’s Laboratories (RDY).
Sucampo entered into a patent settlement and license agreement with Par Pharmaceutical in July 2014 in which Par Pharmaceutical was granted a non-exclusive license to market the generic of Amitiza in the United States, starting in January 2021.
Sucampo entered into a similar settlement and license agreement with Dr. Reddy’s Laboratories in which Dr. Reddy’s was granted a non-exclusive license to market the generic form of Amitiza in the United States. The license is applicable from November 2022.
According to these agreements, Sucampo has agreed to supply the drug under a manufacturing and supply agreement finalized in September 2015 in the event Par or Dr. Reddy’s chooses to launch their own authorized generic of Amitiza.
Sucampo has licensed commercialization rights for Amitiza to Mylan in Japan and Harbin Gloria Pharmaceuticals in China.
Sucampo received approval for Amitiza in Japan in 2012. Amitiza is the only approved medicine in Japan for chronic constipation.
Sucampo Pharmaceuticals makes up 0.04% of the iShares Nasdaq Biotechnology’s (IBB) total portfolio holdings.
In the next part of this series, we’ll take a look at the drug candidates in Sucampo’s R&D (research and development) pipeline.