Regeneron Provides Update on Biologics License Application for Odronextamab
March 25 2024 - 7:00AM
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that
the U.S. Food and Drug Administration (FDA) has issued Complete
Response Letters (CRLs) for the Biologics License Application (BLA)
for odronextamab in relapsed/refractory (R/R) follicular lymphoma
(FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after
two or more lines of systemic therapy. The only approvability issue
is related to the enrollment status of the confirmatory trials. The
CRLs – one for R/R FL and one for R/R DLBCL – did not identify any
approvability issues with the odronextamab clinical efficacy or
safety, trial design, labeling or manufacturing.
Regeneron has been actively enrolling patients in multiple Phase
3 trials for odronextamab as part of the OLYMPIA program – one of
the largest clinical programs in lymphoma. As the OLYMPIA program
is intended to change the treatment paradigm of several B-cell
non-Hodgkin lymphoma subtypes – including in earlier lines of
therapy – in agreeing to the program, the FDA required that the
trials include both dose-finding and confirmatory portions.
Enrollment in the dose-finding portion has begun, but the CRLs
indicate that the confirmatory portions of these trials should be
underway and that the timelines to completion be agreed prior to
resubmission. Regeneron is committed to working closely with the
FDA and investigators to bring odronextamab to patients with R/R FL
and R/R DLBCL as quickly as possible. Regeneron plans on sharing
updates on enrollment and regulatory timelines later this year.
Regulatory review of odronextamab remains ongoing by the
European Medicines Agency (EMA) for the treatment of R/R DLBCL and
R/R FL. In the European Union, odronextamab was granted Orphan Drug
Designation in DLBCL and FL.
The potential use of odronextamab in R/R DLBCL and R/R FL is
currently under clinical development and has not been approved by
any regulatory authority.
About RegeneronRegeneron is a leading
biotechnology company that invents, develops and commercializes
life-transforming medicines for people with serious diseases.
Founded and led for over 35 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to numerous FDA-approved treatments and
product candidates in development, almost all of which were
homegrown in our laboratories. Our medicines and pipeline are
designed to help patients with eye diseases, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic
diseases, hematologic conditions, infectious diseases and rare
diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies, such
as VelocImmune®, which uses unique genetically humanized mice
to produce optimized fully human antibodies and bispecific
antibodies, and through ambitious research initiatives such as the
Regeneron Genetics Center®, which is conducting one of the largest
genetics sequencing efforts in the world.
For more information about Regeneron, please
visit www.Regeneron.com or follow Regeneron
on LinkedIn.
Forward-Looking Statements and Use of Digital
MediaThis press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. (“Regeneron” or the “Company”), and actual events or results
may differ materially from these forward-looking statements. Words
such as “anticipate,” “expect,” “intend,” “plan,” “believe,”
“seek,” “estimate,” variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of products marketed
or otherwise commercialized by Regeneron and/or its collaborators
or licensees (collectively, “Regeneron’s Products”) and product
candidates being developed by Regeneron and/or its collaborators or
licensees (collectively, “Regeneron’s Product Candidates”) and
research and clinical programs now underway or planned, including
without limitation odronextamab; the likelihood, timing, and scope
of possible regulatory approval and commercial launch of
Regeneron’s Product Candidates (such as odronextamab, including any
potential regulatory approval of odronextamab by the U.S. Food and
Drug Administration (the “FDA”) based on the Biologics License
Application discussed in this press release (the “odronextamab
BLA”) or the regulatory review by the European Medicines Agency
referenced in this press release) and new indications for
Regeneron’s Products; the impact of the Complete Response Letters
for the odronextamab BLA discussed in this press release (the
“CRLs”) on the timing of the potential regulatory approval of
odronextamab by the FDA and whether and how timely Regeneron is
able to resolve the issues identified in the CRLs (including
Regeneron’s ability to enroll patients in the confirmatory portions
of the Phase 3 trials for odronextamab referenced in this press
release); uncertainty of the utilization, market acceptance, and
commercial success of Regeneron’s Products and Regeneron’s Product
Candidates (such as odronextamab) and the impact of studies
(whether conducted by Regeneron or others and whether mandated or
voluntary) on any of the foregoing or any potential regulatory
approval of Regeneron’s Products and Regeneron’s Product
Candidates; the ability of Regeneron’s collaborators, licensees,
suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron’s Products and
Regeneron’s Product Candidates; the ability of Regeneron to manage
supply chains for multiple products and product candidates; safety
issues resulting from the administration of Regeneron’s Products
and Regeneron’s Product Candidates (such as odronextamab) in
patients, including serious complications or side effects in
connection with the use of Regeneron’s Products and Regeneron’s
Product Candidates in clinical trials; determinations by regulatory
and administrative governmental authorities which may delay or
restrict Regeneron’s ability to continue to develop or
commercialize Regeneron’s Products and Regeneron’s Product
Candidates; ongoing regulatory obligations and oversight impacting
Regeneron’s Products, research and clinical programs, and business,
including those relating to patient privacy; the availability and
extent of reimbursement of Regeneron’s Products from third-party
payers, including private payer healthcare and insurance programs,
health maintenance organizations, pharmacy benefit management
companies, and government programs such as Medicare and Medicaid;
coverage and reimbursement determinations by such payers and new
policies and procedures adopted by such payers; competing drugs and
product candidates that may be superior to, or more cost effective
than, Regeneron’s Products and Regeneron’s Product Candidates; the
extent to which the results from the research and development
programs conducted by Regeneron and/or its collaborators or
licensees may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; unanticipated expenses; the
costs of developing, producing, and selling products; the ability
of Regeneron to meet any of its financial projections or guidance
and changes to the assumptions underlying those projections or
guidance; the potential for any license, collaboration, or supply
agreement, including Regeneron’s agreements with Sanofi and Bayer
(or their respective affiliated companies, as applicable) to be
cancelled or terminated; the impact of public health outbreaks,
epidemics, or pandemics (such as the COVID-19 pandemic) on
Regeneron's business; and risks associated with intellectual
property of other parties and pending or future litigation relating
thereto (including without limitation the patent litigation and
other related proceedings relating to EYLEA® (aflibercept)
Injection), other litigation and other proceedings and government
investigations relating to the Company and/or its operations, the
ultimate outcome of any such proceedings and investigations, and
the impact any of the foregoing may have on Regeneron’s business,
prospects, operating results, and financial condition. A more
complete description of these and other material risks can be found
in Regeneron’s filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31,
2023. Any forward-looking statements are made based on management’s
current beliefs and judgment, and the reader is cautioned not to
rely on any forward-looking statements made by Regeneron. Regeneron
does not undertake any obligation to update (publicly or otherwise)
any forward-looking statement, including without limitation any
financial projection or guidance, whether as a result of new
information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (https://investor.regeneron.com) and its
LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
Contacts:Media
RelationsTammy Allen Tel: +1
914-306-2698tammy.allen@regeneron.com |
Investor RelationsVesna TosicTel:
+1 914-847-5443vesna.tosic@regeneron.com |
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