Biogen and Ginkgo Bioworks Announce Collaboration and License Agreement to Develop Novel Gene Therapy Manufacturing Platform
May 21 2021 - 7:30AM
Biogen and Ginkgo Bioworks Announce Collaboration and License
Agreement to Develop Novel Gene Therapy Manufacturing Platform
Biogen (Nasdaq: BIIB) and Ginkgo Bioworks today announced a gene
therapy collaboration. Together, the companies aim to redefine the
industry standard for manufacturing recombinant adeno-associated
virus (AAV)-based vectors.
Recombinant AAV-based vectors are widely used to develop
innovative gene therapies and have the potential to treat certain
neurological and neuromuscular diseases as well as other conditions
across multiple therapeutic areas. Currently, manufacturing is
time-consuming and expensive making it difficult to develop
therapies for diseases with high dose needs and with large patient
populations. Ginkgo seeks to solve these challenges by applying its
mammalian cell programming platform, with the aim to improve the
efficiency of AAV-producing plasmid vectors and cell lines, which
could accelerate Biogen’s development of novel gene therapies.
“We believe that Ginkgo’s unique combination of cell programming
expertise, proprietary tools and knowledge of biological systems
make them an ideal collaboration partner to explore a large number
of design ideas with the goal of optimizing constructs,” said
Alphonse Galdes, Ph.D., Head of Pharmaceutical Operations and
Technology at Biogen. “They share our goal of ensuring approved
therapies are not delayed by manufacturing constraints and are
available to patients worldwide.”
“We are excited to collaborate with Biogen as they aim to
develop treatments that may potentially slow, halt or cure
neurological and neurodegenerative diseases and seek to enhance the
industry standard for AAV manufacturing,” said Jason Kelly, CEO of
Ginkgo Bioworks. “Synthetic biology is leveraging the power of
living cells to develop the next generation of therapeutics,
everything from CAR-T, to CRISPR and gene therapies, which we
believe will have a material impact on the lives of many.”
Under the terms of the agreement, Biogen will receive access to
Ginkgo’s proprietary cell programming platform and capabilities.
Ginkgo will utilize its bioengineering facilities and resources
with the aim of enhancing the AAV production titers of Biogen’s
gene therapy manufacturing processes. Ginkgo will receive an
upfront payment of $5 million and is eligible for milestone
payments up to an additional $115 million should the collaboration
programs achieve certain research, developmental and commercial
milestones.
About Biogen At Biogen, our mission is clear:
we are pioneers in neuroscience. Biogen discovers, develops and
delivers worldwide innovative therapies for people living with
serious neurological and neurodegenerative diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners
Walter Gilbert and Phillip Sharp. Today Biogen has the leading
portfolio of medicines to treat multiple sclerosis, has introduced
the first approved treatment for spinal muscular atrophy,
commercializes biosimilars of advanced biologics and is focused on
advancing research programs in multiple sclerosis and
neuroimmunology, Alzheimer’s disease and dementia, neuromuscular
disorders, movement disorders, ophthalmology, neuropsychiatry,
immunology, acute neurology and neuropathic pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media –
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About Ginkgo BioworksGinkgo is building a
platform to program cells as easily as we can program computers.
The company's platform is enabling the growth of biotechnology
across diverse markets, from food and agriculture to industrial
chemicals to pharmaceuticals. Ginkgo is also actively supporting a
number of COVID-19 response efforts, including community testing,
epidemiological tracing, vaccine development and therapeutics
discovery. For more information,
visit www.ginkgobioworks.com.
Biogen Safe HarborThis news release contains
forward-looking statements, including statements made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, relating to the potential benefits and results
that may be achieved through Biogen’s collaboration with Ginkgo
Bioworks; the identification and treatment of neurological and
neuromuscular diseases; Biogen’s research and development programs;
the potential benefits of gene therapy, including a gene therapy
manufacturing platform; risks and uncertainties associated with
drug development and commercialization; the potential of Biogen’s
commercial business and pipeline programs; and Biogen’s strategy
and plans, including related to gene therapy. These forward-looking
statements may be accompanied by words such as “aim,” “anticipate,”
“believe,” “could,” “estimate,” “expect,” “forecast,” “intend,”
“may,” “plan,” “potential,” “possible,” “will,” “would” and other
words and terms of similar meaning. Drug development and
commercialization involve a high degree of risk, and only a small
number of research and development programs result in
commercialization of a product. You should not place undue reliance
on these statements or the scientific data presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including, without limitation, uncertainty as to
whether the anticipated benefits of the collaboration can be
achieved; risks of unexpected costs or delays or other unexpected
hurdles; uncertainty of success in the development of a gene
therapy manufacturing platform, which may be impacted by, among
other things, unexpected concerns that may arise from data or
analysis, the occurrence of adverse safety events, failure to
obtain regulatory approvals in certain jurisdictions, failure to
protect and enforce data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; the direct and indirect impacts of
the ongoing COVID-19 pandemic on Biogen’s business, results of
operations and financial condition; product liability claims; and
third party collaboration risks. The foregoing sets forth many, but
not all, of the factors that could cause actual results to differ
from Biogen’s expectations in any forward-looking statement.
Investors should consider this cautionary statement as well as the
risk factors identified in Biogen’s most recent annual or quarterly
report and in other reports Biogen has filed with the U.S.
Securities and Exchange Commission. These statements are based on
Biogen’s current beliefs and expectations and speak only as of the
date of this news release. Biogen does not undertake any obligation
to publicly update any forward-looking statements, whether as a
result of new information, future developments or otherwise.
BIOGEN MEDIA CONTACT: |
BIOGEN INVESTOR CONTACT: |
Natacha Gassenbach |
Mike Hencke |
Tel: (617) 679-4945 |
Tel: (781) 464-2442 |
public.affairs@biogen.com |
IR@biogen.com |
GINKGO MEDIA CONTACTS: |
GINKGO INVESTOR CONTACTS: |
press@ginkgobioworks.com |
investors@ginkgobioworks.com |
ginkgobioworks@missionnorth.com |
investors@eagleequityptnrs.com |
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