The drug is being tested for the treatment of NPC-1 (Niemann-Pick Disease Type C1), a fatal disease caused by a defect in lipid transports within the cell. The drug is being studied in Phase 2b and 3 trials and has been granted breakthrough therapy and orphan drug designation in the United States. Results from these trials are expected in mid-2018. Currently, there are no approved products to treat NPC-1 in the United States.
Competition for Amitiza
In the branded prescription category, Amitiza competes with Ironwood Pharmaceuticals (IRWD) and Allergan’s (AGN) Linzess, which is approved for CIC (chronic idiopathic constipation) and IBS-C (irritable bowel syndrome with constipation). Synergy Pharmaceuticals’ (SGYP) Trulance and Valeant’s (VRX) Relistor are its competitors. Linzess and Trulance are capsules that need to be taken once per day. Amitiza must be taken twice per day.
The total revenue earned by Sucampo on product sales and royalties of Amitiza was ~$140 million in 2015 and ~$201 million in 2016. In comparison, Linzess generated revenues of ~$86 million for Ironwood Pharmaceuticals (IRWD) in 3Q17. Trulance, which was approved by the FDA (U.S. Food & Drug Administration) in January 2017 for CIC, generated revenues of ~$5 million for Synergy Pharmaceuticals (SGYP) in 3Q17. Total revenues Sucampo Pharmaceuticals generated for Amitiza in 3Q17 were ~$56 million.
Sucampo makes up 0.11% of the iShares S&P Small-Cap 600 Growth’s (IJT) total portfolio holdings.
In the next part of this series, we’ll take a look at Sucampo’s financial performance.