Full Press Release Details
AC Immune and Lilly Announce License
and Collaboration Agreement
Lausanne, Switzerland, and Indianapolis,
IN, USA, December 12, 2018 - 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 $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
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
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).
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
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.
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
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.
For further information, please contact:
AC Immune Corporate - Europe
Phone: +41 79 281 6494
E-mail: david.lowe@acimmune.com
AC Immune Media Relations - US
Phone: +1 617-792-3937
AC Immune Investor Relations
Phone: +1 970 987 26 54
E-mail: lisa.sher@acimmune.com
Lilly Media Relations
Phone: +1 317 276 5795
E-mail: mark.taylor@lilly.com
Lilly Investor Relations
Phone: +1 317 277 1838
E-mail: hern_kevin_r@lilly.com
Source: AC Immune SA