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news.US-based biotechnology firm Celgene has entered into a global license agreement with Irish pharmaceutical firm Nogra Pharma, 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.
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Recently, 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 on the data, which has been submitted to a major medical journal, the company intends to start a Phase III registration program by year-end 2014.
Celgene senior vice president and global head of Inflammation and Immunology Scott Smith said GED-0301 is a potentially transformative therapy that showed striking clinical activity in a Phase II trial for Crohn’s disease.
"It strengthens our expanding pipeline of novel therapies intended to address significant unmet medical need in immune-mediated diseases," Smith said.
As part of the deal, Nogra Pharma will receive an upfront payment of $710m, regulatory, development and net sales milestone payments and tiered royalties.
According to the company, aggregate payments for regulatory and development milestones could potentially be $815m for multiple indications.
The company said that the license deal will become effective upon the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.