MacroGenics Earns $15 Million Milestone Following U.S. FDA Approval of ZYNYZ™ (retifanlimab-dlwr)
22 Marzo 2023 - 11:22AM
MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company
focused on developing and commercializing innovative antibody-based
therapeutics for the treatment of cancer, today reported that
following the U.S. Food and Drug Administration’s (FDA) approval of
Incyte’s Biologics License Application (BLA) for ZYNYZ™
(retifanlimab-dlwr), the Company will receive a $15 million
milestone payment from Incyte. ZYNYZ, a humanized monoclonal
antibody targeting programmed death receptor-1 (PD-1), was
previously developed by MacroGenics and licensed to Incyte pursuant
to an exclusive global collaboration and license agreement in
October 2017.
“The FDA approval of ZYNYZ represents the third approval of a
product originating from MacroGenics’ pipeline of proprietary or
partnered product candidates,” said Scott Koenig, M.D., Ph.D.,
President and Chief Executive Officer of MacroGenics. “We are
delighted that with the approval of ZYNYZ, there is now an
additional option for treating patients with Merkel cell carcinoma,
a rare and aggressive type of skin cancer. We also look forward to
Incyte’s continued progress in advancing their development of
retifanlimab across additional indications and geographies.”
Under the terms of the license agreement, beyond the $15 million
approval milestone, MacroGenics is also eligible to receive up to a
total of $320 million in potential remaining development and
regulatory milestones and up to $330 million in potential
commercial milestones from Incyte. In addition, MacroGenics is
eligible to receive tiered royalties of 15% to 24% on any global
net sales of the product. Finally, MacroGenics has an agreement
with Incyte under which it manufactures a portion of Incyte’s
global commercial supply of retifanlimab.
About MacroGenics, Inc.
MacroGenics (the Company) is a biopharmaceutical company focused
on developing and commercializing innovative monoclonal
antibody-based therapeutics for the treatment of cancer. The
Company generates its pipeline of product candidates primarily from
its proprietary suite of next-generation antibody-based technology
platforms, which have applicability across broad therapeutic
domains. The combination of MacroGenics' technology platforms and
protein engineering expertise has allowed the Company to generate
promising product candidates and enter into several strategic
collaborations with global pharmaceutical and biotechnology
companies. For more information, please see the Company's website
at www.macrogenics.com. MacroGenics and the MacroGenics logo are
trademarks or registered trademarks of MacroGenics, Inc.
Cautionary Note on Forward-Looking
Statements
Any statements in this press release about future expectations,
plans and prospects for MacroGenics (“Company”), including
statements about the Company’s strategy, future operations,
clinical development of the Company’s therapeutic candidates,
including initiation and enrollment in clinical trials, expected
timing of results from clinical trials, discussions with regulatory
agencies, commercial prospects of or product revenues from MARGENZA
and the Company’s product candidates, if approved, manufacturing
services revenue, milestone or opt-in payments from the Company’s
collaborators, the Company’s anticipated milestones and future
expectations and plans and prospects for the Company, as well as
future global net sales of TZIELD and the Company’s ability to
achieve the milestone payments set forth under the terms of the
agreement with DRI, and other statements containing the words
“subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”,
“estimate”, “potential,” “project”, “may”, “will”, “should”,
“would”, “could”, “can”, the negatives thereof, variations thereon
and similar expressions, or by discussions of strategy constitute
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: risks that TZIELD, vobramitamab
duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product
candidate’s revenue, expenses and costs may not be as expected,
risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab,
ZYNYZ, MARGENZA or any other product candidate’s market acceptance,
competition, reimbursement and regulatory actions; our ability to
provide manufacturing services to our customers; the uncertainties
inherent in the initiation and enrollment of future clinical
trials; the availability of financing to fund the internal
development of our product candidates; expectations of expanding
ongoing clinical trials; availability and timing of data from
ongoing clinical trials; expectations for the timing and steps
required in the regulatory review process; expectations for
regulatory approvals; expectations of future milestone payments;
the impact of competitive products; our ability to enter into
agreements with strategic partners and other matters that could
affect the availability or commercial potential of the Company's
product candidates; business, economic or political disruptions due
to catastrophes or other events, including natural disasters,
terrorist attacks, civil unrest and actual or threatened armed
conflict, or public health crises such as the novel coronavirus
(referred to as COVID-19 pandemic); and other risks described in
the Company's filings with the Securities and Exchange Commission.
In addition, the forward-looking statements included in this press
release represent the Company's views only as of the date hereof.
The Company anticipates that subsequent events and developments
will cause the Company's views to change. However, while the
Company may elect to update these forward-looking statements at
some point in the future, the Company specifically disclaims any
obligation to do so, except as may be required by law. These
forward-looking statements should not be relied upon as
representing the Company's views as of any date subsequent to the
date hereof.
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CONTACT:
Jim Karrels, Senior Vice President, CFO
1-301-251-5172
info@macrogenics.com
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