AC Immune and Lilly Announce License and Collaboration Agreement
December 12 2018 - 06:30AM
Business Wire
- Multi-year agreement focuses on
Morphomer tau aggregation inhibitors, for the potential treatment
of Alzheimer’s disease and other neurodegenerative diseases.
- AC Immune to receive an initial upfront
payment of CHF80 million and will be eligible for CHF60 million in
potential near-term development milestones, up to approximately
CHF1.7 billion in other potential development, regulatory and
commercial milestones, and low double-digit royalties.
- Lilly to purchase $50 million note,
convertible to equity position in AC Immune.
AC Immune SA (NASDAQ: ACIU) and Eli Lilly and Company (NYSE:LLY)
today announced that the two companies have signed a license and
collaboration agreement to research and develop tau aggregation
inhibitor small molecules for the potential treatment of
Alzheimer’s disease (AD) and other neurodegenerative diseases. The
collaboration combines AC Immune’s proprietary MorphomerTM platform
technology with Lilly’s clinical development expertise and
commercial capabilities in central nervous system disorders. The
collaboration will focus primarily on AC Immune’s lead molecule,
ACI-3024, which has demonstrated tau aggregation inhibition in
preclinical models.
Under the terms of the agreement, AC Immune will receive an
upfront payment of CHF80 million as well as $50 million in exchange
for a note, convertible to equity at a premium. AC Immune is also
eligible to receive CHF60 million in potential near-term
development milestones, as well as other potential development,
regulatory and commercial milestones up to approximately CHF1.7
billion, and tiered royalty payments in the low double digits.
AC Immune will conduct the initial Phase 1 development of the
Morphomer tau aggregation inhibitors, while Lilly will fund and
conduct further clinical development. Lilly will receive worldwide
commercialization rights for the tau aggregation inhibitors in the
area of Alzheimer’s disease. AC Immune has retained certain
development rights in orphan indications and co-development and
co-promotion options in certain indications outside AD.
Prof. Andrea Pfeifer, CEO of AC Immune, said: “This landmark
partnership with Lilly is transformational for the future of AC
Immune. Lilly’s substantial experience in neurology, and
particularly in Alzheimer’s disease, is a major validation of our
small-molecule platform for CNS therapeutics. It also demonstrates
the potential of our pre-clinical assets and adds substantial value
to our pipeline. We look forward to working closely with Lilly in
this exciting field over the coming years.”
“Lilly is an industry leader in Alzheimer’s research, with
numerous ongoing scientific programs that target suspected causes
of the disease, including amyloid plaques and tau tangles,” said
Mark Mintun, M.D., vice president of neurodegeneration and pain
research at Lilly. “This agreement with AC Immune represents
another opportunity to hopefully make progress against this
devastating disease, and we look forward to together bringing tau
aggregation inhibitors into clinical development.”
This transaction will be reflected in Lilly's reported results
and financial guidance according to Generally Accepted Accounting
Principles (GAAP). There will be no change to Lilly's 2018 non-GAAP
earnings per share guidance as a result of this transaction. This
transaction is subject to clearance under the Hart-Scott-Rodino
Antitrust Improvements Act and other customary closing
conditions.
About AC Immune’s Tau Morphomers™Several chemical series
of small molecules (MorphomersTM) have been identified which
selectively and potently reduce toxic intracellular misfolded and
aggregated tau. Targeting intracellular misfolded and aggregated
tau is widely recognized as an important and attractive potential
approach for interfering with the spread of tau pathology
throughout the brain. In some proof-of-concept tauopathy models,
reduction of tau pathology was also accompanied by a reduction of
associated neuroinflammatory markers – another key pathologic
feature of Alzheimer’s disease (AD).
About AC ImmuneAC Immune is a clinical-stage Swiss-based
biopharmaceutical company, listed on NASDAQ, which aims to become a
global leader in precision medicine for neurodegenerative diseases.
The Company designs, discovers and develops therapeutic as well as
diagnostic products intended to prevent and modify diseases caused
by misfolding proteins. AC Immune’s two proprietary technology
platforms create antibodies, small molecules and vaccines designed
to address a broad spectrum of neurodegenerative indications, such
as Alzheimer’s disease (AD). The Company’s pipeline features nine
therapeutic and three diagnostic product candidates – with five
product candidates currently in clinical trials.
About Eli Lilly and CompanyLilly is a global healthcare
leader that unites caring with discovery to create medicines that
make life better for people around the world. We were founded more
than a century ago by a man committed to creating high-quality
medicines that meet real needs, and today we remain true to that
mission in all our work. Across the globe, Lilly employees work to
discover and bring life-changing medicines to those who need them,
improve the understanding and management of disease, and give back
to communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
http://newsroom.lilly.com/social-channels.
AC Immune Forward-Looking StatementThis press release
contains statements that constitute “forward-looking statements”
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Forward-looking
statements are statements other than historical fact and may
include statements that address future operating, financial or
business performance or AC Immune’s strategies or expectations. In
some cases, you can identify these statements by forward-looking
words such as “may,” “might,” “will,” “should,” “expects,” “plans,”
“anticipates,” “believes,” “estimates,” “predicts,” “projects,”
“potential,” “outlook” or “continue,” and other comparable
terminology. Forward-looking statements are based on management’s
current expectations and beliefs and involve significant risks and
uncertainties that could cause actual results, developments and
business decisions to differ materially from those contemplated by
these statements. These risks and uncertainties include those
described under the captions “Item 3. Key Information – Risk
Factors” and “Item 5. Operating and Financial Review and Prospects”
in AC Immune’s Annual Report on Form 20-F and other filings with
the Securities and Exchange Commission. Forward-looking statements
speak only as of the date they are made, and AC Immune does not
undertake any obligation to update them in light of new
information, future developments or otherwise, except as may be
required under applicable law. All forward-looking statements are
qualified in their entirety by this cautionary statement.
Lilly Forward-Looking StatementThis press release
contains forward-looking statements (as that term is defined in the
Private Securities Litigation Reform Act of 1995) about the
benefits of the license and collaboration with AC Immune, and
reflects Lilly's current beliefs. However, as with any such
undertaking, there are substantial risks and uncertainties in the
process of drug development and commercialization. Among other
things, there can be no guarantee that Lilly will realize the
expected benefits of the license and collaboration, or that the
license and collaboration will yield a commercially successful
product. For a further discussion of these and other risks and
uncertainties that could cause actual results to differ from
Lilly's expectations, please see Lilly's most recent Forms 10-K and
10-Q filed with the U.S. Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20181212005145/en/
AC Immune Corporate – EuropeDavid A. Lowe, PhDPhone: +41
79 281 6494E-mail: david.lowe@acimmune.com
AC Immune Media Relations – USLaVoieHealthScienceKatie
GallagherPhone: +1 617-792-3937E-mail:
kgallagher@lavoiehealthscience.com
AC Immune Investor RelationsLisa SherPhone: +1 970 987 26
54E-mail: lisa.sher@acimmune.com
Lilly Media RelationsMark TaylorPhone: +1 317 276
5795E-mail: mark.taylor@lilly.com
Lilly Investor RelationsKevin HernPhone: +1 317 277
1838E-mail: hern_kevin_r@lilly.com
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