Biogen Inc. (Nasdaq: BIIB) and Denali Therapeutics Inc. (Nasdaq:
DNLI) today announced that they have signed a binding agreement to
co-develop and co-commercialize Denali’s small molecule inhibitors
of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease.
Biogen will also receive rights to opt into two programs and a
right of first negotiation for two additional programs, in each
case for neurodegenerative diseases leveraging Denali’s Transport
Vehicle (TV) technology platform to cross the blood-brain barrier
(BBB).
“Our collaboration with Denali represents an opportunity to
advance the development of a potential first-in-class oral therapy
that may slow the progression of Parkinson’s disease,” said Michel
Vounatsos, Biogen’s Chief Executive Officer. “Denali’s LRRK2
program is highly complementary to our existing Parkinson’s disease
pipeline and its successful development would enhance Biogen’s
portfolio of medicines for treating serious neurological and
neurodegenerative diseases. We look forward to leveraging our
neurology capabilities and infrastructure with Denali’s scientific
expertise to accelerate advancement of this program.”
“We are very excited to collaborate with Biogen, a company with
an impressive history in inventing and developing medicines for
neurological diseases,” said Ryan Watts, Ph.D., Denali’s Chief
Executive Officer. “This collaboration will allow us to accelerate
the development of our LRRK2 program and gives us the resources to
build a fully integrated company with the goal of bringing
transformative medicines to patients suffering from
neurodegenerative diseases.”
Under the agreement, Biogen will collaborate with Denali to
co-develop and co-commercialize Denali’s small molecule inhibitors
of LRRK2 for Parkinson’s disease. Biogen and Denali will
co-commercialize the LRRK2 product in the U.S. and China, and
Biogen will commercialize in all other markets. DNL151 has been
selected to progress into late stage clinical studies expected to
commence in 2021.
Mutations in the LRRK2 gene can cause Parkinson’s disease. LRRK2
is a regulator of lysosomal function, which is impaired in
Parkinson’s disease and may contribute to neurodegeneration.
Inhibition of LRRK2 activity may slow the progression of
Parkinson’s disease in patients with and without known genetic
risks based on restoration of lysosomal function. People who have
Parkinson’s disease experience numerous symptoms, including
tremors, slow movement, muscle stiffness and impaired balance. As
these symptoms become progressively worse, patients have difficulty
walking, talking or completing other simple tasks. Parkinson’s
disease is the second most common neurodegenerative disease with
significant unmet medical needs due to the absence of approved
therapies that may slow disease progression.
In addition to the LRRK2 program, Biogen will also receive an
exclusive option to license two preclinical programs from Denali’s
TV platform, which aims to improve brain uptake of biotherapeutics,
including its Antibody Transport Vehicle (ATV): Abeta program (ATV
enabled anti-amyloid beta program) and a second program utilizing
its TV technology. Further, Biogen will have right of first
negotiation on two additional TV-enabled therapeutics, currently at
a preclinical stage, should Denali decide to seek a collaboration
for such programs. Denali’s TV platform is a proprietary technology
designed to effectively deliver large therapeutic molecules such as
antibodies, enzymes, proteins and oligonucleotides across the BBB
after intravenous administration.
Terms of the Collaboration
Under the terms of the agreement, Biogen will make an upfront
payment to Denali of $560 million and make a $465 million equity
investment in Denali from the purchase of 13.3 million newly issued
shares of Denali common stock at approximately $34.94 per share,
representing 11.2 percent of Denali’s pro-forma outstanding
stock.
Should the LRRK2 program achieve certain development and
commercial milestones, Denali will be eligible to receive up to
$1.125 billion in potential milestone payments.
In the LRRK2 collaboration, Biogen and Denali will share
responsibility and costs for global development (60 percent Biogen;
40 percent Denali), and will share responsibility and costs as well
as profits and losses for commercialization in the U.S. (50 percent
Biogen; 50 percent Denali) and China (60 percent Biogen; 40 percent
Denali). Outside the U.S. and China, Biogen will be responsible for
commercialization and pay Denali tiered royalties.
Closing of the collaboration is contingent on completion of
review under antitrust laws, including the Hart-Scott-Rodino (HSR)
Antitrust Improvements Act of 1976 in the U.S., and other customary
closing conditions.
About Denali’s LRRK2 DNL151 Program
DNL151 is a small molecule inhibitor of LRRK2 invented at Denali
which has completed dosing of 162 healthy volunteers in an ongoing
Phase 1 clinical study and completed dosing in 25 Parkinson’s
patients in a Phase 1b clinical study. Denali is currently
completing further dose escalation cohorts in an expanded Phase 1
and an additional cohort in the Phase 1b study to define the full
therapeutic window of the molecule. Based on the clinical data to
date that has been generated in Europe, DNL151 appears to have an
acceptable safety and tolerability profile and has met desired
target engagement goals. An Investigational New Drug application
for DNL151 was cleared by the U.S. Food and Drug Administration in
July 2020 and enables expansion of Denali clinical trials for
DNL151 globally.
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.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media –
Twitter, LinkedIn, Facebook, YouTube.
About Denali Therapeutics
Denali Therapeutics is a biopharmaceutical company developing a
broad portfolio of product candidates engineered to cross the BBB
for neurodegenerative diseases. Denali Therapeutics pursues new
treatments by rigorously assessing genetically validated targets,
engineering delivery across the BBB and guiding development through
biomarkers that demonstrate target and pathway engagement. Denali
Therapeutics is based in South San Francisco. For additional
information, please visit www.denalitherapeutics.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 Denali; the anticipated
completion of the proposed transaction; the potential benefits,
safety and efficacy of DNL151 and other LRRK2 inhibitor molecules;
the clinical development program for DNL151 and other LRRK2
inhibitor molecules; the potential benefits of Denali’s TV
technology platform and TV programs including its ATV: anti-amyloid
beta program; the treatment of Parkinson’s disease; the potential
of Biogen’s commercial business and pipeline programs; Biogen’s
strategy and plans; the potential treatment of neurological and
neurodegenerative 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 DNL151 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; third party collaboration
risks; and the direct and indirect impacts of the ongoing COVID-19
pandemic on Biogen’s business, results of operations and financial
condition. 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.
Denali Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements expressed or implied in this press
release include, but are not limited to, plans, timelines and
expectations related to DNL151 and other LRRK2 inhibitor molecules,
Denali’s TV technology platform and TV programs including its ATV:
anti-amyloid beta program; LRRK2 inhibitors as modifying therapy
for Parkinson’s disease; the ability of the TV technology to
effectively deliver large therapeutic molecules across the BBB;
expectations regarding the proposed transaction with Biogen,
including all financial aspects of the collaboration and equity
investment; the potential benefits and results of the proposed
transaction with Biogen; the anticipated completion of the
transaction; plans to conduct clinical development activities and
commercialize products; and statements made by Denali’s CEO and
Biogen’s CEO.
Actual results are subject to risks and uncertainties and may
differ materially from those indicated by these forward-looking
statements as a result of these risks and uncertainties, including
but not limited to: any and all risks to Denali’s business and
operations caused directly or indirectly by the evolving COVID-19
pandemic; the risks that the proposed transaction with Biogen may
not be completed in a timely manner or at all; the possibility that
certain closing conditions to the proposed transaction will not be
satisfied, including the finalization of a definitive collaboration
agreement; risks related to obtaining the requisite regulatory
approvals, including those required under antitrust laws; the risk
of the occurrence of any event, change or other circumstance that
could give rise to the termination of the agreements with Biogen
(including without limitation the failure to timely obtain
requisite regulatory approvals); risks related to the effect of the
announcement of the transaction on Denali’s business relationships,
operating results, stock price and business generally; Denali’s
early stages of clinical drug development; Denali’s and its
partners’ ability to complete the development and, if approved,
commercialization of its product candidates; Denali’s and its
partners’ ability to enroll patients in clinical trials; Denali’s
reliance on third parties for the manufacture and supply of its
product candidates for clinical trials; Denali’s dependence on
successful development of its BBB platform technology and whether
the platform technology effectively delivers large therapeutic
molecules across the BBB; Denali’s and its partners’ ability to
conduct or complete clinical trials on expected timelines; the risk
that preclinical profiles of Denali’s product candidates, such as
DNL151, may not translate in clinical trials and that such product
candidates may not sufficiently modify Parkinson’s disease; the
uncertainty that product candidates will receive regulatory
approval necessary to be commercialized; Denali’s ability to
continue to create a pipeline of product candidates or develop
commercially successful products; developments relating to Denali’s
competitors and its industry, including competing product
candidates and therapies; Denali’s ability to obtain, maintain or
protect intellectual property rights related to its product
candidates; implementation of Denali’s strategic plans for its
business, product candidates and BBB platform technology; Denali’s
ability to obtain additional capital to finance its operations, as
needed; Denali’s ability to accurately forecast future financial
results in the current environment; general economic and market
conditions; and other risks and uncertainties, including those
described in Denali’s most recent Annual Report on Form 10-K, most
recent Quarterly Report on Form 10-Q and Denali’s future reports to
be filed with the SEC. The forward-looking statements in this press
release are based on information available to Denali as of the date
hereof. Denali disclaims any obligation to update any
forward-looking statements, except as required by law.
BIOGEN MEDIA CONTACT:Biogen
Inc.David Caouette+ 617 679 4945public.affairs@biogen.com DENALI
THERAPEUTICS CONTACT:Morgan Warners (GPG)+ 202 295
0124mwarners@gpg.com |
BIOGEN INVESTOR CONTACT:Biogen
Inc.Joe Mara+781 464 2442IR@biogen.com |
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