Biogen Inc. (Nasdaq: BIIB) and Sangamo Therapeutics, Inc. (Nasdaq:
SGMO), a genomic medicine company, today announced that they have
executed a global licensing collaboration agreement to develop and
commercialize ST-501 for tauopathies including Alzheimer’s disease,
ST-502 for synucleinopathies including Parkinson’s disease, a third
undisclosed neuromuscular disease target, and up to nine additional
undisclosed neurological disease targets. The companies will
leverage Sangamo’s proprietary zinc finger protein (ZFP) technology
delivered via adeno-associated virus (AAV) to modulate the
expression of key genes involved in neurological diseases.
“As a pioneer in neuroscience, Biogen will collaborate with
Sangamo on a new gene regulation therapy approach, working at the
DNA level, with the potential to treat challenging neurological
diseases of global significance. We aim to develop and advance
these programs forward to investigational new drug applications,”
said Alfred Sandrock Jr., M.D., Ph.D., Executive Vice President,
Research and Development at Biogen.
“There are currently no approved disease modifying treatments
for patients with many devastating neurodegenerative diseases such
as Alzheimer’s and Parkinson’s, creating an urgency for the
development of medicines that will not just address symptoms like
the current standards of care, but slow or stop the progression of
disease,” said Sandy Macrae, CEO of Sangamo. “We believe that the
promise of genomic medicine in neuroscience is to provide a
one-time treatment for patients to alter their disease natural
history by addressing the underlying cause at the genomic
level.”
Sangamo’s genome regulation technology, zinc finger protein
transcription factors (ZFP-TFs), is currently delivered with AAVs
and functions at the DNA level to selectively repress or activate
the expression of specific genes to achieve a desired therapeutic
effect. Highly specific, potent, and tunable repression of tau and
alpha synuclein has been demonstrated in preclinical studies using
AAV vectors to deliver tau-targeted (ST-501) and alpha
synuclein-targeted (ST-502) ZFP-TFs.
“The combination of Sangamo’s proprietary zinc finger
technology, Biogen’s unmatched neuroscience research, drug
development, and commercialization experience and capabilities, and
our shared commitment to bring innovative medicines to patients
with neurological diseases establishes the foundation for a robust
and compelling collaboration,” said Stephane Boissel, Head of
Corporate Strategy at Sangamo. “This collaboration exemplifies
Sangamo’s commitment to our ongoing strategy to partner programs
that address substantial and diverse patient populations in disease
areas requiring complex clinical trial designs and commercial
pathways, therefore bringing treatments to patients faster and more
efficiently, while deriving maximum value from our platform.”
Under the terms of the collaboration, Biogen has exclusive
global rights to ST-501 for tauopathies including Alzheimer’s
disease, ST-502 for synucleinopathies including Parkinson’s
disease, and a third undisclosed neuromuscular disease target. In
addition, Biogen has exclusive rights to nominate up to nine
additional undisclosed targets over a target selection period of
five years. Sangamo will perform early research activities, costs
for which will be shared by the companies, aimed at the development
of the combination of proprietary CNS delivery vectors and ZFP-TFs
targeting therapeutically relevant genes. Biogen will then assume
responsibility and costs for the investigational new drug-enabling
studies, clinical development, related regulatory interactions, and
global commercialization.
Sangamo will be responsible for GMP manufacturing activities for
the initial clinical trials for the first three products of the
collaboration and plans to leverage its in-house manufacturing
capacity. Biogen will assume responsibility for GMP manufacturing
activities beyond the first clinical trial for each of the first
three products.
Upon closing of this transaction, Sangamo will receive $350
million comprised of $125 million in a license fee payment and $225
million from the sale of new Sangamo stock, or approximately 24
million shares at $9.21 per share. In addition, Sangamo may receive
up to $2.37 billion in other development, regulatory, and
commercial milestone payments, including up to $925 million in
pre-approval milestone payments and up to $1,445 million in first
commercial sale and other sales-based milestone payments. Sangamo
will also be eligible to receive from Biogen tiered high single
digit to sub-teen double-digit royalties on potential net
commercial sales of products arising from the collaboration.
Closing of the transaction is contingent on completion of review
under antitrust laws, including the Hart-Scott-Rodino (HSR)
Antitrust Improvements Act of 1976 in the U.S.
Conference callSangamo will host a conference
call at 8:00 a.m. ET tomorrow, Friday, February 28, which will be
open to the public via telephone and webcast. During the conference
call, Sangamo will discuss the collaboration, review financial
results for the fourth quarter and full year 2019, and provide a
business update. The conference call dial-in numbers are (877)
377-7553 for domestic callers and (678) 894-3968 for international
callers. The conference ID number for the call is 4609858.
Participants may access the live webcast via a link on the Sangamo
website in the Investors and Media section under Events and
Presentations. A conference call replay will be available for one
week following the conference call on Sangamo’s website. The
conference call replay numbers for domestic and international
callers are (855) 859-2056 and (404) 537-3406, respectively. The
conference ID number for the replay is 4609858.
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, immunology,
neurocognitive disorders, acute neurology, and pain.
Biogen routinely posts information that may be important to
investors on its website at www.biogen.com. To learn more, please
visit www.biogen.com and follow Biogen on social media –
Twitter, LinkedIn, Facebook, YouTube.
About Sangamo Therapeutics Sangamo
Therapeutics is committed to translating ground-breaking science
into genomic medicines with the potential to transform patients’
lives using gene therapy, ex vivo gene-edited cell therapy, and in
vivo genome editing and gene regulation. For more information about
Sangamo, visit www.sangamo.com.
Biogen Safe Harbor This press release contains
forward-looking statements, made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including statements relating to the potential benefits and results
that may be achieved through Biogen’s proposed collaboration with
Sangamo; the anticipated completion and timing of the proposed
transaction; the potential benefits, safety and efficacy of ST-501
and ST-502; the potential of Biogen’s commercial business and
pipeline programs; Biogen’s strategy and plans; the potential
treatment of neurological diseases; and risks and uncertainties
associated with drug development and commercialization. These
forward-looking statements may be accompanied by words such as
“aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “goal,” “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. Results in early
stage clinical trials may not be indicative of full results or
results from later stage or larger scale clinical trials and do not
ensure regulatory approval. 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: risks that the
proposed transaction will be completed in a timely manner or at
all; the possibility that certain closing conditions to the
proposed transaction will not be satisfied; uncertainty as to
whether the anticipated benefits of the proposed collaboration can
be achieved; risks of unexpected hurdles, costs or delays;
uncertainty of success in the development and potential
commercialization of ST-501 and ST-502 and other undisclosed
neurological targets, which may be impacted by, among other things,
unexpected concerns that may arise from additional data or
analysis, the occurrence of adverse safety events, failure to
obtain regulatory approvals in certain jurisdictions, failure to
protect and enforce Biogen’s data, intellectual property, and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; 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 risks
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 press 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.
Sangamo Forward Looking StatementsThis press
release contains forward-looking statements regarding Sangamo's
current expectations. These forward-looking statements
include, without limitation, statements relating to the potential
to use ZFP technology delivered via AAV to repress specific genes
involved in neurological diseases, the ability of genomic medicine
to provide one-time treatments, other statements regarding
investigational therapies and their therapeutic benefits,
statements related the anticipated effectiveness of the
collaboration and the timing and benefits thereof, Sangamo's sale
of shares of its common stock, receipt of an upfront payment and
potential receipt of development- and sales-based milestones,
as well as royalties on potential future sales, and other
statements that are not historical fact. These statements are not
guarantees of future performance and are subject to risks and
assumptions that are difficult to predict. Factors that could cause
actual results to differ include, but are not limited to, risks and
uncertainties related to: the research and development process; the
ability to cause the agreements to become effective on the proposed
terms and schedule, the ability to obtain clearance under the HSR
and to satisfy the other closing conditions,; and the potential for
technological developments by Sangamo's competitors that will
obviate Sangamo's technologies, the new, uncertain and time
consuming gene regulation therapy development and regulatory
process, including the risks that Sangamo and Biogen may not be
successful in their research efforts under the collaboration and
that, even if successful, Biogen may be unable to successfully
develop and commercialize licensed products resulting from the
collaboration; Sangamo's dependence on collaborative partners,
including the risks that if Biogen were to breach or terminate the
agreement or otherwise fail to successfully develop and
commercialize licensed products resulting from the collaboration
and in a timely manner, Sangamo would not obtain the anticipated
financial and other benefits of the collaboration and the
development and/or commercialization of Sangamo's gene editing
technology could be delayed, perhaps substantially. There can be no
assurance that the necessary milestones or approvals will be
obtained for any of the product candidates in this collaboration.
Actual results may differ from those projected in forward-looking
statements due to risks and uncertainties that exist in Sangamo's
operations and business environments. These risks and uncertainties
are described more fully in Sangamo's filings with the U.S.
Securities and Exchange Commission, including its most recent
Annual Report on Form 10-K and most recent Quarterly Report on Form
10-Q. Forward-looking statements contained in this
announcement are made as of this date, and Sangamo undertakes no
duty to update such information except as required under applicable
law.
BIOGEN MEDIA CONTACT:David
Caouette+ 1 617 679 4945public.affairs@biogen.com SANGAMO MEDIA
CONTACT:Aron Feingold 510-970-6000, x421afeingold@sangamo.com
|
BIOGEN INVESTOR CONTACT:Joe
Mara+1 781 464 2442IR@biogen.com SANGAMO INVESTOR CONTACT:
McDavid Stilwell 510-970-6000,
x219mstilwell@sangamo.com |
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