- Broad collaboration for gene regulation therapies in neurology,
initially focused on development of ST-501 for tauopathies
including Alzheimer’s disease, ST-502 for synucleinopathies
including Parkinson’s disease, and a neuromuscular target, with
exclusive rights for nine additional undisclosed neurological
targets
- Biogen will pay Sangamo $350 million upfront, including a
license fee and an equity investment in Sangamo stock
- Sangamo is eligible to receive up to $2.37 billion in potential
milestones, as well as royalties on potential net commercial
sales
- Biogen’s access to Sangamo's gene regulation therapies
complements its expanding efforts in gene therapy across diverse
neurological diseases
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.
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“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 call
Sangamo 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 Statements
This 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200227005961/en/
BIOGEN MEDIA CONTACT: David Caouette + 1 617 679 4945
public.affairs@biogen.com
SANGAMO MEDIA CONTACT: Aron Feingold 510-970-6000, x421
afeingold@sangamo.com
BIOGEN INVESTOR CONTACT: Joe Mara +1 781 464 2442
IR@biogen.com
SANGAMO INVESTOR CONTACT: McDavid Stilwell 510-970-6000, x219
mstilwell@sangamo.com
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