Celgene announced a global licensing deal Thursday potentially valued at more than $2.5 billion to develop and market Nogra Pharma's experimental drug GED-0301 for moderate-to-severe Crohn's disease and other indications. Scott Smith, Celgene's global head of inflammation and immunology, suggested that GED-0301 "is a potentially transformative therapy that demonstrated striking clinical activity in a Phase II trial for Crohn's disease," adding that the compound "strengthens our expanding pipeline of novel therapies intended to address significant unmet medical need in immune-mediated diseases."
Under the agreement, Celgene will make an upfront payment of $710 million to Nogra, with the latter eligible to receive up to $815 million in development and regulatory milestones for the drug in multiple indications and sales milestones of up to about $1.1 billion, as well as tiered royalties. Celgene said it plans to start a Phase III registration programme this year for the first-in-class oral antisense DNA oligonucleotide, which targets Smad7 mRNA. The drugmaker noted that a mid-stage study of GED-0301 in 166 patients with active Crohn's disease has been completed, with the data submitted for publication in a research journal and scheduled for presentation at a future medical conference.
Separately, Celgene reported Thursday that first-quarter profit declined due to increased R&D costs and higher expenses associated with various drug launches, despite a 19-percent gain in product sales to $1.7 billion.
To read more Top Story articles, click here.