INDIANAPOLIS and SAN
FRANCISCO, July 24, 2017
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Nektar
Therapeutics (NASDAQ: NKTR) have announced a strategic
collaboration to co-develop NKTR-358, a novel immunological therapy
discovered by Nektar. NKTR-358, which achieved first human dose in
Phase 1 clinical development in March of 2017, has the potential to
treat a number of autoimmune and other chronic inflammatory
conditions.
NKTR-358 is a potential first-in-class resolution therapeutic
that may address an underlying immune system imbalance in patients
with many autoimmune conditions. It targets the interleukin
(IL-2) receptor complex in the body in order to stimulate
proliferation of powerful inhibitory immune cells known as
regulatory T cells. By activating these cells, NKTR-358 may
act to bring the immune system back into balance. This could lead
to a profound clinical impact and healthy organ function in
autoimmune conditions.
"We look forward to working with Nektar to study this novel
approach to treating a number of autoimmune conditions," said
Thomas F. Bumol, Ph.D., Senior Vice
President of Biotechnology and Immunology Research at Lilly.
"NKTR-358 is an exciting addition to our immunology portfolio and
reinforces Lilly's commitment to sustain a flow of innovative
medicines in our pipeline."
Under the terms of the agreement, Nektar will receive an initial
payment of $150 million and is
eligible for up to $250 million in
additional development and regulatory milestones. Lilly and Nektar
will co-develop NKTR-358 with Nektar responsible for completing
Phase 1 clinical development. The parties will share Phase 2
development costs 75 percent Lilly and 25 percent Nektar. Nektar
will have the option to participate in Phase 3 development on an
indication-by-indication basis. Nektar has the opportunity to
receive double-digit royalties that increase commensurate with
their Phase 3 investment and product sales. Lilly will be
responsible for all costs of global commercialization. Nektar will
have an option to co-promote in the U.S. under certain
conditions.
"We are very pleased to enter into this collaboration with Lilly
as they have strong expertise in immunology and a successful track
record in bringing novel therapies to market," said Howard W. Robin, Nektar's President and Chief
Executive Officer. "Importantly, this agreement enables the broad
development of NKTR-358 in multiple autoimmune conditions in order
to achieve its full potential as a first-in-class resolution
therapeutic."
This transaction is subject to clearance under the
Hart-Scott-Rodino Antitrust Improvements Act and other customary
closing conditions. Subject to the closing of this transaction,
Lilly expects to incur an acquired in-process research and
development charge to earnings in 2017 of approximately
$0.09 per share. The company's
reported earnings per share guidance in 2017 is expected to be
reduced by the amount of the charge. There will be no change to the
company's non-GAAP earnings per share guidance as a result of this
transaction.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to 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.
About Nektar Therapeutics
Nektar Therapeutics is
a research-based biopharmaceutical company whose mission is to
discover and develop innovative medicines to address the unmet
medical needs of patients. Our R&D pipeline of new
investigational medicines includes treatments for cancer,
auto-immune disease and chronic pain. We leverage Nektar's
proprietary and proven chemistry platform in the discovery and
design of our new therapeutic candidates. Nektar is headquartered
in San Francisco, California, with
additional operations in Huntsville,
Alabama and Hyderabad,
India. Further information about the company and its drug
development programs and capabilities may be found online at
http://www.nektar.com.
C-LLY
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 a strategic alliance between Lilly and Nektar
Therapeutics, and the potential benefits of NKTR-358, 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 collaboration, or that NKTR-358 will yield
commercially successful products. 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.
Nektar Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements which can be identified by words such as: "potential,"
"plan," "expect," "should," "will" and similar references to future
periods. Examples of forward-looking statements include, among
others, statements we make regarding: (i) the therapeutic and
commercial potential of NKTR-358; (ii) development plans related to
NKTR-358; and (iii) the potential of our technology and drug
candidates in our research and development pipeline.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, anticipated
events and trends, the economy and other future conditions. Our
actual results may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any
of these forward-looking statements. Important factors that could
cause our actual results to differ materially from those indicated
in the forward-looking statements include, among others: (i)
NKTR-358 is in early-stage clinical development and the risk of
failure remains high and failure can unexpectedly occur; (ii) the
timing of the commencement or end of clinical trials and the
availability of clinical data may be delayed or unsuccessful due to
many factors; (iii) patents may not issue from our patent
applications for NKTR-358, patents that have issued may not be
enforceable, or additional intellectual property licenses from
third parties may be required; and (iv) certain other important
risks and uncertainties set forth in our Quarterly Report on Form
10-Q with the Securities and Exchange
Commission on May 10, 2017. Any forward-looking statement
made by us in this press release is based only on information
currently available to us and speaks only as of the date on which
it is made. We undertake no obligation to update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Refer
to:
|
Lauren Zierke;
lauren_zierke@lilly.com; 317-277-6524 (Lilly Media)
|
|
Phil Johnson;
johnson_philip_l@lilly.com; 317-655-6874 (Lilly
Investors)
|
|
Dan Budwick;
dan@1abmedia.com; 973-271-6085 (Nektar Media)
|
|
Jennifer Ruddock;
jruddock@nektar.com; 415-482-5585 (Nektar Investors)
|
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SOURCE Eli Lilly and Company; Nektar Therapeutics