- Agreement provides individuals with broader access to a
protein-based non-mRNA adjuvanted COVID-19 vaccine through combined
commercial strength, from 2025 onwards
- Provides Novavax with cash and an equity investment
totalling approximately $1.2 billion
(upfront payment of $500 million and
up to $700 million in additional
development, regulatory and launch milestones), plus tiered
royalties
- Novavax is entitled to additional launch and sales milestone
opportunities of up to $200 million,
plus mid-single digit royalties, for each additional Sanofi vaccine
product developed under a non-exclusive license with Novavax's
Matrix-M™ adjuvant technology
- Accelerates potential for development of a novel
COVID-19-Influenza combination product based on authorized vaccines
with demonstrated efficacy and tolerability, potentially offering
individuals enhanced convenience and protection
GAITHERSBURG, Md., May 10, 2024
/PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company
advancing protein-based vaccines with its Matrix-M™
adjuvant, has entered into a co-exclusive licensing agreement
with Sanofi (Nasdaq: SNY).
The terms of the agreement include: a co-exclusive license to
co-commercialize Novavax's current stand-alone adjuvanted COVID-19
vaccine worldwide (except in countries with existing Advance
Purchase Agreements and in India,
Japan and South Korea where Novavax has existing
partnership agreements); a sole license to Novavax's adjuvanted
COVID-19 vaccine for use in combination with Sanofi's flu vaccines
while Novavax retains the right to and is developing its own
COVID-19-Influenza Combination vaccine candidate; a non-exclusive
license to use Novavax's adjuvanted COVID-19 vaccine for use in
combination with non-flu vaccines; and a non-exclusive license to
use the Matrix-M adjuvant in vaccine products. In addition, Sanofi
will take a minority (<5%) equity investment in Novavax.
"With flu and COVID-19 hospital admission rates now closely
mirroring each other, we have an opportunity to develop non-mRNA
flu-COVID-19 combination vaccines, offering patients both enhanced
convenience and protection against two serious respiratory
viruses," said Jean-Francois
Toussaint, Global Head of Vaccines R&D, Sanofi. "We're
excited by the prospect of combining Novavax's adjuvanted COVID-19
vaccine that has shown high efficacy and favorable tolerability,
with our rich portfolio of differentiated flu vaccines that have
demonstrated superior protection against flu and its serious
complications. Improved tolerability and thermostability, without
compromise on efficacy, are what regulators, recommending bodies
and patients will demand."
"This collaboration is important for Novavax and for global
public health. Our new partnership combines Novavax's proprietary
recombinant protein and nanoparticle technologies, Matrix™ adjuvant
and R&D expertise with Sanofi's world-class leadership in
launching and commercializing innovative vaccines. Together, we can
broaden access to both our COVID-19 vaccine and our adjuvant to
ensure more individuals can benefit from the protection vaccines
can provide," said John C. Jacobs,
President and Chief Executive Officer, Novavax. "Novavax is now in
a stronger position to refocus our efforts on leveraging our
technology platform and novel adjuvant in R&D and pipeline
expansion to help advance our mission of developing life-saving
vaccines to fight infectious diseases."
Under the terms of the licensing agreement:
- Novavax will receive an upfront payment of $500 million and up to $700 million in development, regulatory and
launch milestones, up to $1.2 billion
in total.
- Starting in 2025, Sanofi will book sales of Novavax's
adjuvanted COVID-19 vaccine and will support certain R&D,
regulatory and commercial expenses.
- Novavax will receive tiered double-digit percentage royalty
payments on sales by Sanofi of COVID-19 vaccines and
COVID-19-Influenza Combination vaccines.
- Sanofi will be solely responsible for development and
commercialization of any novel flu-COVID-19 combination vaccine
containing a Sanofi flu vaccine.
- Outside of the collaboration, each party may develop and
commercialize their own COVID-19-Influenza combination vaccines and
adjuvanted products at their own cost.
- Novavax is entitled to additional launch and sales milestone
opportunities of up to $200 million,
plus mid-single digit royalties for each additional Sanofi vaccine
product developed under a non-exclusive license with Novavax's
Matrix-M adjuvant technology.
- In addition, Sanofi will take a minority (<5%) equity
investment in Novavax.
PJT Partners is acting as the exclusive financial advisor to
Novavax. Ropes & Gray LLP is serving as legal advisor.
About Novavax
Novavax, Inc. (Nasdaq: NVAX)
promotes improved health by discovering, developing and
commercializing innovative vaccines to help protect against serious
infectious diseases. Novavax, a global company based in
Gaithersburg, Md., U.S., offers a
differentiated vaccine platform that combines a recombinant protein
approach, innovative nanoparticle technology and Novavax's patented
Matrix-M adjuvant to enhance the immune response. The Company's
portfolio includes its COVID-19 vaccine and its pipeline includes
its COVID-19-Influenza Combination and stand-alone influenza
vaccine candidates. In addition, Novavax's adjuvant is included in
the University of Oxford and Serum
Institute of India's R21/Matrix-M™
malaria vaccine. Please visit novavax.com and LinkedIn for
more information.
About Sanofi
We are an innovative global healthcare
company, driven by one purpose: we chase the miracles of science to
improve people's lives. Our team, across the world, is dedicated to
transforming the practice of medicine by working to turn the
impossible into the possible. We provide potentially life-changing
treatment options and life-saving vaccine protection to millions of
people globally, while putting sustainability and social
responsibility at the center of our ambitions.
Forward-Looking Statements
Statements herein relating
to enhanced access to a protein-based non-mRNA adjuvanted COVID-19
from 2025 onwards, development of COVID-19 combination vaccines
(including COVID-19-Influenza combination vaccines), launching a
phase 3 trial for Novavax's COVID-19-Influenza Combination vaccine
candidate in the second half of 2024, future vaccines made with
Novavax's proprietary Matrix-MTM adjuvant, potential
royalties and milestones, the future of Novavax and its mission are
forward-looking statements. Novavax cautions that these
forward-looking statements are subject to numerous risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. These risks and
uncertainties include, without limitation, Novavax's and Sanofi's
ability to successfully implement its partnership, including the
ability to transition key processes and effect technology
transfers; Novavax's ability to successfully and timely
manufacture, distribute, or market its updated COVID-19 vaccine
including as a single dose vial or pre-filled syringe product
presentation for the 2024-2025 vaccination season; challenges
satisfying, alone or together with partners, various safety,
efficacy, and product characterization requirements, including
those related to process qualification, assay validation and
stability testing, necessary to satisfy applicable regulatory
authorities; challenges or delays in conducting clinical trials;
challenges or delays in obtaining regulatory authorization for its
product candidates, including its updated COVID-19 vaccine in time
for the 2024-2025 vaccination season or for future COVID-19 variant
strain changes, its COVID-19-Influenza Combination vaccine
candidate and its stand-alone influenza vaccine candidate;
manufacturing, distribution or export delays or challenges;
Novavax's substantial dependence on Serum Institute of India Pvt.
Ltd. and Serum Life Sciences Limited for co-formulation and filling
and PCI Pharma Services for finishing Novavax's COVID-19 vaccine
and the impact of any delays or disruptions in their operations on
the delivery of customer orders; difficulty obtaining scarce raw
materials and supplies; resource constraints, including human
capital and manufacturing capacity, constraints on Novavax's
ability to pursue planned regulatory pathways, alone or with
partners, in multiple jurisdictions simultaneously, leading to
staggering of regulatory filings, and potential regulatory actions;
challenges in implementing its global restructuring and cost
reduction plan; Novavax's ability to timely deliver doses;
challenges in obtaining commercial adoption and market acceptance
of its updated COVID-19 vaccine or any COVID-19 variant strain
containing formulation; challenges meeting contractual requirements
under agreements with multiple commercial, governmental, and other
entities, including requirements to deliver doses that may require
Novavax to refund portions of upfront and other payments previously
received or result in reduced future payments pursuant to such
agreements; challenges related to the seasonality of vaccinations
against COVID-19; and those other risk factors identified in the
"Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of
Novavax's Annual Report on Form 10-K for the year ended
December 31, 2023 as filed with the
Securities and Exchange Commission (SEC). We caution investors not
to place considerable reliance on forward-looking statements
contained in this press release. You are encouraged to read our
filings with the SEC, available at www.sec.gov and www.novavax.com,
for a discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of
the date of this document, and we undertake no obligation to update
or revise any of the statements. Our business is subject to
substantial risks and uncertainties, including those referenced
above. Investors, potential investors, and others should give
careful consideration to these risks and uncertainties.
Contacts:
Investors
Erika Schultz
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
240-720-7804
media@novavax.com
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