By Chris Wack
Mesoblast Ltd. said it has filed a request and expects to hold a Type C meeting with the U.S. Food & Drug Administration during the current quarter to discuss the pathway to U.S. regulatory approval for rexlemestrocel-L following the recently completed 404 patient Phase 3 trial in patients with chronic inflammatory back pain due to degenerative disc disease.
The company said the move is part of its strategy for bringing rexlemestrocel-L to patients in the U.S. with chronic low back pain due to degenerative disc disease refractory.
Mesoblast said it plans to use the results from a planned U.S. trial to support potential product approvals in both the U.S. and EU by including 20% EU patients in order to provide regulatory harmonization, cost efficiencies and streamlined timelines, without initiating an EU trial. Mesoblast and its partner in Europe and Latin America, Grunenthal, have amended their collaboration agreement, with Mesoblast being eligible to receive payments up to $112.5 million prior to product launch in the EU, inclusive of $17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved.
Cumulative milestone payments could reach $1 billion depending on the final outcome of Phase 3 studies and patient adoption. Mesoblast also will receive tiered double-digit royalties on product sales as per the original agreement.
Mesoblast shares were up 8% to $8.05 in premarket trading.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires
July 01, 2021 07:49 ET (11:49 GMT)Copyright (c) 2021 Dow Jones & Company, Inc.