Celgene said today it acquired rights to develop and commercialize Nogra Pharma’s GED-0301, a drug for Crohn's disease and other gastrointestinal indications that is set for Phase III registration by year’s end, in a deal that could net the Irish drug developer about $2.6 billion.
Under a global license agreement, Celgene agreed to pay Nogra $710 million upfront, as well as up to $815 million in payments tied to regulatory and development milestones for unspecified “multiple” indications . Nogra would also receive an additional up to $1.05 billion in aggregate tiered sales milestone payments if annual net sales reach $4 billion—the milestone cash starts at $500 million—and tiered royalties.
Celgene’s best-selling drug last year, Revlimid®, generated $4.28 billion in net sales, with approved indications for multiple myeloma in combination with dexamethasone, as well as for mantle cell lymphoma (MCL) and anemia. Revlimid is on pace to beat that number this year, Celgene said today in releasing first-quarter results. The company reported a 14% jump in first-quarter Revlimid sales to $1.144 billion, and affirmed earlier guidance to investors that 2014 net sales are expected to be between $4.9 billion and $5 billion, up about 16% from 2013.
GED-0301 is a first-in-class oral antisense DNA oligonucleotide targeting Smad7 mRNA indicated for moderate-to-severe Crohn's. Celgene said it entered into its deal with Nogra following completion of a multicenter Phase II trial assessing the efficacy of three doses of GED-0301 in 166 patients with active Crohn's disease. Results from the 166-patient Phase II trial have been submitted for publication to “a major medical journal” and will be presented at an undisclosed upcoming medical congress by year’s end.
“GED-0301 is a potentially transformative therapy that demonstrated striking clinical activity in a phase II trial for Crohn's disease,” said Scott Smith, svp 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.”
The license agreement will take effect upon expiration or termination of the applicable waiting period under the amended Hart-Scott-Rodino Antitrust Improvements Act of 1976.
If it succeeds in Phase III and goes on to enter the market, GED-0301 would join a Celgene portfolio of inflammatory and immunology drugs that includes Otezla® (apremilast). While Otezla won FDA approval in March as the first treatment indicated for psoriatic arthritis in active adults, the drug was in Phase I study for Crohn’s disease among several additional indications as of last month. Otezla has a September 23 PDUFA date for an FDA decision on a second indication, psoriasis.
Another Celgene drug candidate is indicated for Crohn’s—the cell therapy PDA-001, which is now preclinical studies.