XOMA Announces License Agreement With Novo Nordisk for XMetA Program in Diabetes
December 01 2015 - 8:30AM
- Novo Nordisk acquires exclusive global rights to XMetA program
for the treatment of diabetes
- XOMA retains commercialization rights for rare disease
indications
- $5.0 million upfront payment
- Agreement includes up to $290.0 million in additional potential
milestone payments
- XOMA is entitled to tiered royalties
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced today it has
exclusively licensed the global development and commercialization
rights to its XMetA program of allosteric monoclonal antibodies
that up-regulate the insulin receptor to Novo Nordisk A/S. Under
the terms of the agreement, XOMA retains commercialization rights
for rare disease indications. Novo Nordisk has an option to add
these additional rights in rare diseases to its license. XOMA will
receive $5.0 million in the form of an upfront payment, and the
agreement includes up to $290.0 million in additional potential
development, regulatory and commercial milestones (excluding
potential option payments). In addition, XOMA is eligible to
receive tiered royalties on product sales.
"Novo Nordisk is recognized globally as the leader in the
development of therapies to treat diabetes mellitus. It has the
expertise to further develop these first-in-class insulin receptor
activators, which were discovered by XOMA's scientists," said Jim
Neal, Senior Vice President and Chief Operating Officer at XOMA.
"Our corporate strategy is to develop novel therapeutics for
endocrine diseases, particularly those that are considered rare,
and we were able to structure the agreement with Novo Nordisk to
retain commercialization rights of the XMetA program for rare
indications."
"XOMA's scientists probed the insulin receptor in order to
identify a novel way of treating type 2 diabetes mellitus. Their
work resulted in the XMetA program, a series of novel, fully human,
high affinity, allosteric monoclonal antibodies that are partial
agonists of the insulin receptor. Over the past few years, we have
made significant progress in understanding the pharmacology of the
compounds in this program," stated Paul Rubin, M.D., Senior Vice
President, Research and Development and Chief Medical Officer at
XOMA. "In vitro data have shown the lead compound in the XMetA
program mimics insulin's glucose regulatory functions, but none of
its mitogenic actions. Most recently, weekly subcutaneous treatment
with the lead molecule in the XMetA program in a clinically
relevant animal model of diabetes resulted in robust decreases in
hyperglycemia without hypoglycemia and weight gain, along with a
significant absolute reduction in HbA1c of 1.2 percent. These
findings have been peer-reviewed and were published online in the
Journal of Pharmacology and Experimental Therapeutics in November
2015. They provide greater confidence in the development potential
of XMetA as a first-in-class pharmacotherapy with broad utility in
type 2 diabetes."
About the XMetA Program
Conventional monoclonal antibodies bind at the ligand-receptor
binding site to provide either complete activation or inhibition.
However, many receptors also have sites, termed allosteric sites,
binding to which modulates the ligand-receptor interaction. XOMA
developed proprietary methods for identifying allosteric modulating
monoclonal antibodies using its ModulXâ„¢ technology platform and
focuses part of its research effort toward the discovery of these
types of antibodies. The compounds in the XMet programs, which
include the licensed XMetA antibodies and XOMA's 129 and 358, are
fully human, high-affinity, allosteric monoclonal antibodies that
selectively modulate the insulin receptor (INSR).
XMetA antibodies bind with high affinity to the INSR and have
glucoregulatory activity, as well as reduce hypoglycemia and weight
gain in preclinical models of diabetes. The antibodies are partial
INSR agonists as they do not upregulate INSR activity to the same
extent as insulin. Structurally unrelated to insulin, XMetA
antibodies bind the INSR at a different site than insulin and do
not significantly interfere with insulin binding.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90
years of innovation and leadership in diabetes care. This heritage
has given it experience and capabilities that also enable it to
help people defeat other serious chronic conditions: hemophilia,
growth disorders and obesity. Headquartered in Denmark, Novo
Nordisk employs approximately 40,300 people in 75 countries and
markets its products in more than 180 countries. Novo Nordisk's B
shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are
listed on the New York Stock Exchange (NVO). For more information,
visit www.novonordisk.com.
About XOMA Corporation
XOMA Corporation is a leader in the discovery and development of
therapeutic antibodies. The Company's innovative product candidates
result from its expertise in developing ground-breaking monoclonal
antibodies, including allosteric antibodies, which have created new
opportunities to potentially treat a wide range of human diseases.
XOMA's scientific research has produced a portfolio of six
endocrine assets, each of which has the opportunity to address
multiple indications. The Company's lead product candidate, XOMA
358, is an allosteric monoclonal antibody that reduces insulin
receptor activity, which could have a major impact on the treatment
of hyperinsulinism. The Company recently initiated Phase 2
development activities for XOMA 358 in patients with congenital
hyperinsulinism. Additionally, XOMA is developing gevokizumab (IL-1
beta modulating antibody) in an ongoing Phase 3 program enrolling
patients with pyoderma gangrenosum, a rare ulcerative skin
condition. For more information, visit www.xoma.com.
Forward-Looking Statements
Certain statements contained in this press release including,
but not limited to, statements related to therapeutic potential of
our product candidates, including the XMetA program, anticipated
progress and timing of clinical trials, the anticipated receipt by
XOMA of royalty or milestone payments, or statements that otherwise
relate to future periods are 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. These statements are
based on assumptions that may not prove accurate, and actual
results could differ materially from those anticipated due to
certain risks inherent in the biotechnology industry and for
companies engaged in the development of new products in a regulated
market. Potential risks to XOMA meeting these expectations are
described in more detail in XOMA's most recent filing on Form 10-Q
and in other SEC filings. Consider such risks carefully when
considering XOMA's prospects. Any forward-looking statement in this
press release represents XOMA's views only as of the date of this
press release and should not be relied upon as representing its
views as of any subsequent date. XOMA disclaims any obligation to
update any forward-looking statement, except as required by
applicable law.
CONTACT: XOMA Contacts:
Company and Investor Contacts:
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Media Contact:
Ryan Flinn, W2O Group
415-946-1059
rflinn@w2ogroup.com
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