Analyst: Celgene's New Crohn’s Drug Facing Fibrotic Challenges
Published: Sep 11, 2014
September 11, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
The new Crohn’s disease drug Celgene bought the rights to last April for $710 million is unlikely to be a "once daily" product due to the theoretical risk of fibrotic changes with long term exposure, Chief Financial Officer Peter Kellogg told analysts Wednesday.
Mark Schoenebaum, a biotech and pharmaceuticals analyst and medical doctor for ISI Group, said in a report that Kellogg said Celgene remains committed to testing GED-0301, an oral antisense DNA oligonucleotide targeting Smad7 mRNA for the treatment of moderate-to-severe Crohn's disease and other indications.
“The company is very interested in studying re-treatment and/or intermittent dosing, e.g. three months on/three months off),” wrote Schoenbaum in a note.
Celgene scooped up the licensing rights to GED-0301 for an upfront payment of $710 million and regulatory, development and net sales milestone payments and tiered royalties in April 2014. It estimated at the time that regulatory and development milestones could potentially be $815 million for multiple indications.
Celgene will need that money to get through the regulatory process, said market watchers, although how much could be difficult to gauge right now.
“It's still very early days as the program has only been fully in-house for [less than] two months,” said Schoenbaum. “As such, no decisions have yet been made and Celgene has not yet talked to FDA about this.”
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 company said that starting from global annual net sales levels of $500 million, aggregate tiered sales milestones could total a maximum of $1.05 million if annual net sales reach $4,000 million.