Tag: European rights
Company News: 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.
The termination of the agreement follows Almirall’s recent repositioning of their R&D organization to leverage strong formulation capabilities and high-quality New Chemical Entities (NCEs) in Dermatology. Almirall has communicated that their 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.
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.
Company News: InDex Pharmaceuticals and Almirall enter into a license agreement for European rights of the phase III drug candidate Kappaproct®
InDex Pharmaceuticals and Almirall announced today that they have signed a license agreement for the European marketing rights to the drug candidate Kappaproct®. Under the terms of the agreement, InDex is eligible for an upfront payment as well as success driven milestone payments with a total deal value that could exceed EUR100M. InDex is also entitled to receive double digit royalties from Almirall on the European net sales of Kappaproct®.
InDex Pharmaceutical’s lead drug candidate Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) that targets the toll-like receptor 9 (TLR9). Kappaproct is a potential treatment for severe Ulcerative Colitis (UC), a debilitating, chronic inflammation of the large intestine. The results from the ongoing Phase III trial COLLECT are expected in mid-2014.