Celgene Corporation has entered into a global license agreement with Nogra Pharma Limited, 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. The data have been submitted to a major medical journal and will be presented at an upcoming medical congress. 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.” 

Under the terms of the license agreement, Nogra Pharma Limited 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 million if annual net sales reach $4,000 million. 

The license agreement 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.

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FACT: Celgene are ranked 26th out of the Top 50 Pharma Companies (based on revenue in 2012)