Biotech companies in worldwide development agreement
Two European biotech companies - Serono, of Geneva in Switzerland, and InDex Pharmaceuticals, located at Karolinska Institutet in Stockholm, Sweden - have signed an agreement under which Serono receives exclusive worldwide rights to develop and commercialise InDex's product Kappaproct for the treatment of ulcerative colitis and potentially other inflammatory diseases.
Two European biotech companies - Serono, of Geneva in Switzerland, and InDex Pharmaceuticals, located at Karolinska Institutet in Stockholm, Sweden - have signed an agreement under which Serono receives exclusive worldwide rights to develop and commercialise InDex's product Kappaproct for the treatment of ulcerative colitis and potentially other inflammatory diseases.
Kappaproct is an antisense inhibitor of the p65 protein, a key activator of the pro-inflammatory NF-kappa B pathway.
Under the terms of the agreement, InDex will receive an initial fee and potential milestone payments related to development progress, regulatory submissions and approvals, as well as r&d funding. If Kappaproct is successfully developed and registered worldwide in at least one indication, these payments could reach US$35m. InDex will also receive undisclosed royalties on sales.
Kappaproct is currently being tested in a Phase II clinical trial for active ulcerative colitis involving 150 patients. In a completed proof-of-concept, double-blind placebo-controlled clinical trial in patients with therapy-resistant inflammatory bowel disease, the majority of these patients responded positively to a single dose of Kappaproct.
'Ulcerative colitis is a severe debilitating disease and represents a high unmet medical need,' said Franck Latrille, Serono's senior executive vice president global product development. "Kappaproct has the potential to be a significant breakthrough by inducing clinical remission in patients with active ulcerative colitis without compromising safety.'