INDIANAPOLIS and SOUTH SAN FRANCISCO, Calif., Feb. 18, 2021 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL)
today announced a global exclusive license agreement and strategic
collaboration to co-develop and commercialize Rigel's R552, a
receptor-interacting serine/threonine-protein kinase 1 (RIPK1)
inhibitor, for all indications including autoimmune and
inflammatory diseases. Pursuant to the collaboration, Lilly will
also lead all clinical development of brain penetrating RIPK1
inhibitors in central nervous system (CNS) diseases.
Rigel's lead RIPK1 inhibitor, R552, has completed Phase 1
clinical trials and will begin Phase 2 clinical trials in 2021 as
part of the collaboration. Rigel also has ongoing
pre-clinical activities with its lead CNS penetrant RIPK1 inhibitor
candidates.
Under the terms of the agreement, Lilly will pay an upfront cash
payment to Rigel of $125 million.
Rigel may also be eligible to receive up to $835 million in potential development,
regulatory, and commercial milestone payments, as well as tiered
royalties ranging from the mid-single digit to high-teens that will
vary depending upon Rigel's clinical development investment. Lilly
and Rigel will co-develop R552 at specified contribution levels.
Lilly will be responsible for all costs of global commercialization
for R552, and Rigel will have the right to co-commercialize R552 in
the U.S. Lilly will be solely responsible for all clinical
development and commercialization of brain penetrating RIPK1
inhibitors in CNS indications.
RIPK1 is a critical signaling protein implicated in a broad
range of key inflammatory cellular processes including necroptosis,
a type of regulated cell death, and cytokine production. In
necroptosis, cells rupture leading to the dispersion of cell
contents which can trigger an immune response and enhance
inflammation. Inhibiting RIPK1 may be a new approach to treating
various autoimmune, inflammatory, and neurodegenerative disorders.
In pre-clinical studies, Rigel's R552 demonstrated prevention of
joint and skin inflammation in a RIPK1-mediated murine model of
inflammation and tissue damage.
"At Lilly, our immunology strategy is focused on the pursuit of
novel targets that have the potential to develop into best-in-class
medicines for patients with autoimmune conditions," said
Ajay Nirula, M.D., Ph.D., vice
president of immunology at Lilly. "RIPK1 inhibitors are a promising
approach, and R552 is an exciting addition to our immunology
pipeline. We look forward to working with Rigel to advance its
clinical development."
"We are very excited to form this strategic partnership with
Lilly. This collaboration will provide significant resources and
expertise to support a broad investigation in multiple disease
indications with our RIPK1 inhibitors," said Raul Rodriguez, Rigel's president and CEO. "With
Lilly's extensive knowledge in immune and CNS diseases, they are
our ideal partner to ensure the clinical and commercial success of
our RIPK1 inhibitor program."
This transaction is subject to customary closing conditions,
including clearance under the Hart-Scott-Rodino (HSR) Antitrust
Improvements Act of 1976. 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 2021 non-GAAP earnings per share guidance as a
result of this transaction.
About Rigel
Rigel Pharmaceuticals, Inc., is a
biotechnology company dedicated to discovering, developing and
providing novel small molecule drugs that significantly improve the
lives of patients with hematologic disorders, cancer and rare
immune diseases. Rigel's pioneering research focuses on signaling
pathways that are critical to disease mechanisms. To learn more
about Rigel, please visit us at www.rigel.com.
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. C-LLY
Rigel Forward Looking Statements
This release
contains forward-looking statements relating to, among other
things, Rigel's partnership with Lilly; Rigel's ability to achieve
development, regulatory and commercial milestone payments under its
agreement with Lilly; and the potential indications that
inhibiting RIPK1 may affect. Any statements contained in this press
release that are not statements of historical fact may be deemed to
be forward-looking statements. Words such as "potential," "may,"
"expects" and similar expressions are intended to identify these
forward-looking statements. These forward-looking statements are
based on Rigel's current expectations and inherently involve
significant risks and uncertainties. Actual results and the timing
of events could differ materially from those anticipated in such
forward looking statements as a result of these risks and
uncertainties, which include, without limitation, risks and
uncertainties associated with the commercialization and marketing
of TAVALISSE; risks that the FDA, EMA or other regulatory
authorities may make adverse decisions regarding fostamatinib;
risks that TAVALISSE clinical trials may not be predictive of
real-world results or of results in subsequent clinical trials;
risks that TAVALISSE may have unintended side effects, adverse
reactions or incidents of misuses; the availability of resources to
develop Rigel's product candidates; market competition; as well as
other risks detailed from time to time in Rigel's reports filed
with the Securities and Exchange Commission, including its Annual
Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form
10-Q for the quarter ended September 30,
2020. In addition, the COVID-19 pandemic may result in
further delays in Rigel's studies, trials and sales, or impact
Rigel's ability to obtain supply of TAVALISSE. Rigel does not
undertake any obligation to update forward-looking statements and
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein.
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 license and collaboration agreement between Lilly and
Rigel, Lilly's development strategy, and potential payments to
Rigel in connection with the license and collaboration, and
reflects Lilly's current beliefs and expectations. However, as with
any such undertaking, there are substantial risks and uncertainties
in the process of drug research, development, and
commercialization. Among other things, there can be no guarantee
that Lilly will realize the expected benefits of the license and
collaboration, that the license and collaboration will yield
commercially successful products, or that Lilly will execute its
strategy as expected. 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)
|
|
Rigel Investor
Contact - (650) 624-1232; ir@rigel.com
|
|
Rigel Media Contact –
(508) 314-3157; emily.correia@syneoshealth.com
|
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SOURCE Eli Lilly and Company; Rigel Pharmaceuticals