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.
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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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