Maryland-based Sucampo Pharmaceuticals is acquiring Swiss holding company Sucampo AG and its wholly owned Japan-based patent holding subsidiary for $28.1 million in cash and a seven-year subordinated unsecured promissory note of $51.9 million. The acquired businesses had been owned by Sucampo’s co-founders and majority shareholders, Ryuji Ueno, M.D., and Sachiko Kuno, Ph.D., who developed the prostone biolipid IP underpinning Sucampo’s portfolio of marketed and pipeline therapeutics.
Prostones are derived from naturally occurring functional fatty acids, which act as selective ion channel activators, Sucampo states. Its deal to acquire the underlying IP will in addition negate future royalty and milestone payment obligations to third parties outside Sucampo and its subsidiaries and obviates certain mandatory funding requirements for the development of early-stage compounds.
Sucampo’s portfolio is headed by the FDA-approved gastrointestinal drug Amitiza® (lubiprostone), which was sanctioned in 2006 for the treatment of chronic idiopathic constipation in adults and in 2008 for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
Sucampo’s development pipeline includes prostone-based candidates for the treatment of a range of gastrointestinal and other disorders. Additional development of Amitiza is ongoing for the treatment of chronic idiopathic constipation (CIC) in pediatric patients with renal impairment, patients with hepatic impairment, and for treating opioid-induced bowel dysfunction. Phase IV pediatric, renal impairment, and hepatic impairment trials have been completed and submitted to FDA, and Phase III efficacy studies in opioid induced bowel dysfunction have also been completed, the firm notes.
In November Sucampo and partner Abbott Japan reported positive top-line data from a long-term Phase III CIC study with lubiprostone in Japan, where the drug has yet to be cleared. Sucampo and Abbott signed a Japanese license, commercialization, and supply agreement for lubiprostone in February 2009. Under terms of the deal Abbott has exclusive rights to commercialize lubiprostone in Japan for the treatment of CIC, and the right of first refusal to any additional indications for which lubiprostone is developed in Japan. Sucampo continues to head the development of and regulatory activity for lubiprostone in Japan.
Sucampo’s second lead candidate, cobiprostone, has completed a Phase IIa trial for the prevention of NSAID-induced ulcers and is separately in preclinical development for wound healing applications and as an inhaled product for the treatment for COPD. SPI-017 is a prostone candidate undergoing Phase I trials in Japan for the potential treatment of peripheral arterial disease. SPI-3608 is in preclinical development for the treatment of spinal stenosis.
The only other prostone-based drug to have received marketing approval is the glaucoma therapy Rescula® (unoprostone isopropyl). Although not one of Sucampo’s marketed products, Rescula was developed by R-Tech Ueno, another company led by Sucampo’s co-founders, Drs. Ueno and Kuno. The drug was commercialized in Japan in 1994 and is now marketed in over 40 countries worldwide, Sucampo notes. The firm does have limited commercialization rights to Rescula in the U.S., where the product is cleared for the treatment of glaucoma, and Sucampo is also carrying out preclinical development of Rescula for treating dry age-related macular degeneration.