Celgene entered into a global license agreement with Nogra Pharma, a private pharmaceutical company based in Dublin, Ireland, to develop and commercialize GED-0301, an oral antisense DNA oligonucleotide targeting Smad7 mRNA for the treatment of moderate-to-severe Crohn's disease and other indications.
A double-blind, placebo-controlled, multicenter phase II trial of three doses of GED-0301 in 166 patients with active Crohn's disease has been completed. Based upon these results, Celgene plans to initiate a phase III registration program by year-end 2014.
"GED-0301 is a potentially transformative therapy that demonstrated striking clinical activity in a phase II trial for Crohn's disease," said Scott Smith, senior vice president and global head of Inflammation and Immunology. "It strengthens our expanding pipeline of novel therapies intended to address significant unmet medical need in immune-mediated diseases."
Nogra Pharma will receive an upfront payment of $710 million, regulatory, development and net sales milestone payments and tiered royalties. Aggregate payments for regulatory and development milestones could potentially be $815 million for multiple indications. Starting from global annual net sales levels of $500 million, aggregate tiered sales milestones could total a maximum of $1,050 billion if annual net sales reach $4,000 million.