Mesoblast to Hold Type C Meeting With FDA for Back Pain Treatment
01 Julho 2021 - 9:04AM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
July 01, 2021 07:49 ET (11:49 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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