INDIANAPOLIS and LAUSANNE,
Switzerland, Dec. 12, 2018 /PRNewswire/ --
- 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.
Eli Lilly and Company (NYSE:LLY) and AC Immune SA (NASDAQ: ACIU)
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
Morphomer™ 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.
"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."
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."
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 (Morphomers™) 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 Immune
AC 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 Company
Lilly 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. C-LLY
AC Immune Forward-Looking Statement
This 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 Statement
This 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.
Refer to: Mark
Taylor; mark.taylor@lilly.com; (317) 276-5795 (Lilly
Media)
Kevin Hern; hern_kevin_r@lilly.com;
(317) 277-1838 (Lilly Investors)
Katie Gallagher;
kgallagher@lavoiehealthscience.com; 312-792-3937 (ACI Media
US)
Dr. David Lowe;
david.lowe@acimmune.com; +41 79 281 6494 (ACI Corporate-EU)
Lisa Sher; lisa.sher@acimmune.com;
(970) 987-2654 (ACI Investors)
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SOURCE Eli Lilly and Company