Takeda and Denali Therapeutics Collaborate to Develop and Commercialize Therapies for Neurodegenerative Diseases
January 05 2018 - 6:00AM
Business Wire
Collaboration includes three named programs for
the treatment of Alzheimer’s disease and other neurodegenerative
diseases, utilizing Denali’s Antibody Transport Vehicle (ATV)
technology to enhance blood-brain barrier (BBB) penetration.
Takeda Pharmaceutical Company Limited (TSE: 4502) and Denali
Therapeutics (NASDAQ: DNLI) today announced that they have entered
into a strategic option and collaboration agreement to develop and
commercialize up to three specified therapeutic product candidates
for neurodegenerative diseases. Each program is directed to a
genetically validated target for neurodegenerative disorders,
including Alzheimer’s disease and other indications, and
incorporates Denali’s ATV platform for increased exposure of
biotherapeutic products in the brain.
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“This partnership further exemplifies Takeda’s continued
commitment to developing genetically validated therapies for
neurodegenerative diseases through an enhanced portfolio comprised
of new modalities,” said Emiliangelo Ratti, Head of the
Neuroscience Therapy Area at Takeda. “We are excited to partner
with the Denali team, whose innovative technology is uniquely
poised to deliver the next generation of antibody therapeutics for
patients.”
“We are impressed with Takeda’s commitment to developing
treatments for difficult to treat neurodegenerative diseases and
look forward to partnering with them to bring medicines to
patients,” said Denali CEO Ryan Watts, Ph.D. “Takeda has a great
track record of partnering with biotech firms in addition to unique
development expertise and a strong global commercial presence.”
Terms of Collaboration
Under the terms of the agreement, Takeda will make an initial
payment to Denali of $150 million through a combination of cash
upfront payments and the purchase of Denali equity. In addition,
Denali is eligible to receive development and commercial milestone
payments, including $90 million in preclinical milestones and
opt-in payments.
Denali will be responsible for all development activities and
costs prior to IND filing for each of the three programs. Takeda
has the option to co-develop and co-commercialize each of the three
programs. If Takeda exercises the option, the parties will then
jointly conduct clinical development and share all costs equally.
Denali will lead early clinical development activities and Takeda
will lead late stage clinical development activities. Takeda and
Denali will jointly commercialize products in the United States and
China, and Takeda will have exclusive commercialization rights in
all other markets. The parties will share global profits equally.
The agreement will become effective when the requirements of the
Hart–Scott–Rodino Antitrust Improvements Act of 1976 have been
satisfied.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global,
research and development-driven pharmaceutical company committed to
bringing better health and a brighter future to patients by
translating science into life-changing medicines. Takeda focuses
its R&D efforts on oncology, gastroenterology and neuroscience
therapeutic areas plus vaccines. Takeda conducts R&D both
internally and with partners to stay at the leading edge of
innovation. New innovative products, especially in oncology and
gastroenterology, as well as Takeda’s presence in emerging markets,
are currently fueling the growth of Takeda. Approximately 30,000
Takeda employees are committed to improving quality of life for
patients, working with Takeda’s partners in health care in more
than 70 countries. For more information, visit
https://www.takeda.com/newsroom/.
Additional information about Takeda is available through its
corporate website, www.takeda.com, and additional information about
Takeda Oncology, the brand for the global oncology business unit of
Takeda Pharmaceutical Company Limited, is available through its
website, www.takedaoncology.com.
About Denali Therapeutics
Denali is a biopharmaceutical company developing a broad
portfolio of therapeutic candidates for neurodegenerative diseases.
Denali is based in South San Francisco. For additional information,
please visit www.denalitherapeutics.com.
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, the potential benefits of
the collaboration; plans to conduct clinical development activities
and commercialize products; the expectation as to when the
agreement will become effective; and other information relating to
the transaction between Takeda and Denali. 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: the risk that the agreement may not become effective in a
timely manner or at all; risks related to obtaining the
requisite regulatory approvals; the risk of the occurrence of any
event, change or other circumstance that could give rise to the
termination of the agreement (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 and business
generally; and other risks, including those described in Denali’s
Prospectus filed with the SEC on December 8, 2017. The
forward-looking statements in this press release are based on
information available to Denali as of the date
hereof. Denali and Takeda disclaim any obligation to update
any forward-looking statements, except as required by law.
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version on businesswire.com: http://www.businesswire.com/news/home/20180105005161/en/
Takeda Contact:Kelly Schlemm,
+1-617-551-8865kelly.schlemm@takeda.comorDenali Therapeutics
Contact:Morgan Warners, +1-202-295-0124mwarners@gpg.com
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