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  • 30 June 2015
    InDex Pharmaceuticals regains European rights to Kappaproct® in ulcerative colitis

    InDex Pharmaceuticals today announced the termination of a license agreement with Almirall S.A. relating to the drug candidate Kappaproct® for the treatment of ulcerative colitis. Under the agreement, which was signed in March 2014, Almirall licensed exclusive rights to Kappaproct® for the European market. Upon termination of the agreement, InDex regains all worldwide development and commercialization rights for Kappaproct®, which is in late-stage clinical development.

    “Over the past 15 months, we have had an excellent and very productive collaboration with our colleagues at Almirall,” said Wenche Rolfsen, Chairman of InDex Pharmaceuticals. “The data we have generated together strongly support continued development of Kappaproct® as a promising and well-tolerated novel therapeutic option for refractory ulcerative colitis patients and we remain committed to continuing the clinical development program and fulfilling our goal of bringing Kappaproct® to market.”

    The termination of the agreement follows Almirall’s recent repositioning of its R&D organization to leverage strong formulation capabilities and high-quality New Chemical Entities (NCEs) in Dermatology. Almirall has communicated that its new strategy is to become a leading specialty pharmaceutical company with a strong focus on improving the lives of Dermatology patients and that the company will use its strong cash position to fund growth opportunities in this direction.

    “With global rights to Kappaproct® back in our hands, we have all options available regarding the structure of future licensing transactions, which provides strategic leeway in our business development efforts,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “We have a strong package to offer partners with an interest in inflammation and gastrointestinal diseases such as IBD.”

    Kappaproct® is InDex Pharmaceutical’s lead drug candidate and is in late-stage clinical development for moderate to severe ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) that targets the toll-like receptor 9 (TLR9). The recent COLLECT study was conducted in seven European countries and included 131 patients with moderate to severe ulcerative colitis with inadequate response to conventional therapy. They received either Kappaproct® or placebo in addition to conventional treatment. Kappaproct® demonstrated statistically significant effects on endpoints that are highly relevant both from a regulatory and clinical perspective such as key clinical symptoms, i.e. blood in stool and number of stools, and mucosal healing. The primary endpoint of clinical remission at 12 weeks using the CAI score was not met due to an unexpectedly high placebo rate for this endpoint. The next clinical study with Kappaproct® is currently being planned in discussion with EU and US regulatory agencies.