
The Irish biotech recently completed a mid-stage trial of GED-0301 in 166 patients with active Crohn’s disease. Based on the results, Celgene plans to begin late-stage studies by the end of 2014.
“GED-0301 is a potentially transformative therapy that demonstrated striking clinical activity in a phase II trial for Crohn’s disease,” says Scott Smith, head of Inflammation and Immunology at Celgene. “It strengthens our expanding pipeline of novel therapies intended to address significant unmet medical need in immune-mediated diseases.”
Under the terms of their agreement, Nogra Pharma will receive $710 million upfront. Nogra is also eligible for regulatory and development milestones that could potentially be $815 million for multiple indications. Sales-based milestones could add up to another $1,050 million if annual net sales of the drug reach $4 billion.
GED-0301 is a first-in-class, oral antisense drug that binds to the Smad7 messenger RNA to treat moderate to severe Crohn’s. Antisense drugs are synthetic copies of nucleic acids that work by binding to RNA to shut down disease causing genes.
With its outsized upfront payment, Celgene’s largest to date, the company is banking on successfully adding it to its small but growing anti-inflammatory pipeline. In March, Celgene received U.S. regulatory approval for Otezla to treat psoriatic arthritis and expects a decision on its use to treat psoriasis in September.
April 25, 2014
http://www.burrillreport.com/article-celgene_pays_nogra_pharma_710m_upfront_for_late_stage_crohns_disease_drug.html