Date: 2014-04-24
Type of information: Licensing agreement
Compound: GED-0301 (antisense DNA oligonucleotide targeting Smad7 mRNA)
Company: Celgene (USA - NJ) Nogra Pharma (Ireland)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Digestive diseases
Type agreement: licensing development commercialisation
Action mechanism: GED-0301 is an oral antisense DNA oligonucleotide targeting Smad7 mRNA. Smad7 is an inhibitor of Transforming Growth Factor (TGF)-Beta1 activity,
Disease: Crohn's Disease
Details: * On April 24, 2014, Celgene 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. 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.
Financial terms: 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 .
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