Full Press Release Details
and Catalent Biologics Enter Strategic Partnership:
Catalent Biologics to Expand Gene Therapy Footprint with Acquisition of Novavax' Manufacturing Assets and Capabilities
MD, June 27, 2019 (GLOBE NEWSWIRE) - Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation
vaccines for serious infectious diseases, and Catalent Biologics' Paragon Gene Therapy unit, the leading viral vector development
and manufacturing partner for gene therapies, today announced an arrangement under which Paragon Gene Therapy will assume the leases
to two Novavax product development and manufacturing facilities, giving it immediate access to state-of-the-art manufacturing equipment,
people and space to accelerate the growth of its gene therapy development and manufacturing business.
arrangement significantly reduces Novavax' operating costs and provides a cash payment at closing of approximately $18 million.
This cost savings and cash infusion allow Novavax to focus on advancing NanoFlu and ResVax through the next phases
of clinical development and regulatory review.
the terms of the agreement, Paragon Gene Therapy will purchase from Novavax all of the related manufacturing equipment and facility
assets; in addition, over 100 of Novavax' highly qualified manufacturing and quality employees will transfer to Paragon.
Concurrently, Novavax will be entering into a long-term arrangement with Paragon to provide process development and manufacturing
services for specified Novavax programs. The transactions are expected to close in July 2019.
alliance is a true win-win-win for Paragon, Novavax and our employees," said Stanley C. Erck, President and Chief Executive
Officer of Novavax. "This mutually beneficial transaction allows Paragon to quickly support the growth of its gene therapy
development and manufacturing business and simultaneously offers Novavax a strategic and cost-effective approach to addressing
its manufacturing needs into the future."
Novavax employees at the two sites will transfer to Paragon and will continue to provide process and analytical development and,
potentially, manufacture GMP materials for Novavax' clinical trial supplies for NanoFlu and ResVax, among other new projects.
These employees will also provide continuity and support of Novavax' biologics license applications and post-licensure activities.
Over the longer term, Paragon will be available to manufacture commercial quantities of the vaccines for Novavax.
advanced GMP development and manufacturing capabilities and, even more importantly, its very strong team of experts, will help
accelerate our gene therapy manufacturing strategy and rapid growth," said Pete Buzy, President of Paragon's gene therapy
business. "We welcome the new Novavax employees to the Paragon family and look forward to working closely together in this
strategic collaboration to advance Novavax' innovative recombinant vaccines platform and expand our ability to serve the
burgeoning gene and cell therapy market."
transaction allows Novavax to focus on discovery, clinical work, regulatory licensure and commercialization of innovative vaccines
that may improve on existing approaches to prevent serious infectious diseases. We are happy to have found a great home for our
valued team members transferring to Paragon where they can make a real difference in developing new gene therapies and we thank
them for their important contributions to Novavax' progress" Mr. Erck said.
(Nasdaq:NVAX), is a late-stage biotechnology company that drives improved health globally through the discovery, development, and
commercialization of innovative vaccines to prevent serious infectious diseases. ResVax , its RSV vaccine for infants via
maternal immunization, is the only vaccine in a Phase 3 clinical program and is designed to prevent severe lower respiratory tract
infection which is the second leading cause of death in children under one year of age worldwide. Novavax is also advancing NanoFlu ,
its quadrivalent influenza nanoparticle vaccine, to address key factors that can lead to the poor effectiveness of currently approved
flu vaccines. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines
the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent
global health needs.
For more information, visit www.novavax.com
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About Catalent Biologics
Biologics has 20+ years' experience in development, manufacturing, and analytical services for new biological entities, biosimilars,
gene therapies and antibody-drug conjugates. Catalent has worked with 600+ mAbs and 80+ proteins, and more than 115 clinical trials
and 11 marketed products have used GPEx cell line engineering technology. A further 20 commercially-approved products have
employed Catalent Biologics' capabilities through to aseptic fill/finish. Using advanced protein improvement technology and
tailored solutions from DNA through to clinical and commercial supply, Catalent Biologics brings better biologic treatments to
patients, faster. For more information, visit biologics.catalent.com.
Gene Therapy, a unit of Catalent Biologics, is an industry leader focusing on transformative technologies, including gene therapies
(AAV), next-generation vaccines, and oncology immunotherapies. Paragon Gene Therapy has two facilities in Baltimore, Maryland dedicated
to process development through commercial manufacturing of most scalable AAV platforms across multiple serotypes. Since 2016, Paragon
Gene Therapy has completed over 100 clinical GMP AAV batches across 40 programs.
Forward-Looking Statements
relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements.
Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual
results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified
under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2018, and
Quarterly Report on Form 10-Q for the period ended March 31, 2019, as filed with the Securities and Exchange Commission (SEC).
We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You
are encouraged to read our filings with the SEC, available at sec.gov, 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.
Senior Manager, Investor & Public Relations
BrandZone/ KOGS Communication