Ligand Licenses Glucagon Receptor Antagonist Program to Roivant Sciences
LGD-6972 to be a foundational program for Metavant, a new company
formed by Roivant to pursue the development of innovative therapies for
cardiometabolic diseases
SAN DIEGO--(BUSINESS WIRE)--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today
announced the signing of a license agreement granting Roivant Sciences
exclusive global rights to develop and commercialize LGD-6972, Ligand’s
glucagon receptor antagonist (GRA). Under the terms of the agreement,
Ligand will receive upfront license fees, and is eligible to receive
clinical and regulatory milestone payments as well as sales-based
milestone payments and royalties. Roivant will be responsible for all
costs related to the program, effective immediately. Further details
regarding the transaction and an update to Ligand’s 2018 guidance are
provided in Ligand’s Form 8-K being filed today with the Securities and
Exchange Commission (SEC).
LGD-6972 is a novel, potent, oral, small-molecule GRA. In September 2017
Ligand announced positive topline results from a Phase 2 clinical study
evaluating the efficacy and safety of LGD-6972 as an adjunct to diet and
exercise in patients with type 2 diabetes mellitus (T2DM) inadequately
controlled on metformin monotherapy. Full data from the Phase 2 trial
has been submitted for presentation at the 78th annual
Scientific Sessions of the American Diabetes Association being held in
Orlando from June 22-26, 2018.
"This global license with Roivant for our diabetes program is another
important deal in a long history of success converting our inventions,
data and intellectual property into licenses to advance promising
medicines and deliver value to our shareholders," said John Higgins,
Chief Executive Officer, Ligand Pharmaceuticals. "Roivant is well
capitalized and they are assembling an experienced team at Metavant to
efficiently drive the program forward. This is a major partnership that
has the potential to generate substantial medical value for both type 1
and type 2 diabetes patients. If LGD-6972 is successfully developed,
this license with Roivant has the potential to be Ligand's largest
financial asset with the possibility of annual royalties into the late
2030s given current and pending IP."
Roivant is a privately-held company that has established multiple
subsidiary biopharmaceutical companies focused on distinct disease
areas, each with dedicated leadership and development-stage programs.
With its affiliates, Roivant has raised more than $2.7 billion in
capital to date to fund clinical programs and pursue adjacent business
opportunities in healthcare. Roivant recently formed Metavant Sciences
to develop LGD-6972 (now RVT-1502) as well as imeglimin (RVT-1501),
another novel clinical-stage oral antidiabetic therapy. Metavant is
focused on addressing the significant unmet medical needs of patients
with cardiometabolic disorders. Roivant is also evaluating additional
assets for Metavant’s pipeline.
About LGD-6972
Glucagon is a hormone produced by the pancreas that stimulates the liver
to produce glucose (sugar). Overproduction of glucose by the liver is an
important cause of high glucose levels in patients with T2DM and is due
in part to inappropriately elevated levels of glucagon. GRAs are
designed to lower glucose levels by reducing the production of glucose
by the liver. Other small-molecule GRAs have demonstrated a reduction of
glucose and hemoglobin A1c (HbA1c) in mid-stage clinical trials, but
also produced dose-dependent or significant side effects, such as
increases in LDL cholesterol, body weight and blood pressure, that have
impeded further clinical development.
LGD-6972 is a small-molecule GRA. Based in part on unique elements of
the chemical structure of LGD-6972 compared with other small molecules
that have been tested clinically, Ligand believes LGD-6972, if approved,
could potentially be a valuable addition to the armamentarium of
treatments for diabetes.
LGD-6972 has been studied in preclinical and Phase 1 and Phase 2
clinical studies in subjects with T2DM. Presentations from preclinical
studies have shown that LGD-6972 is highly potent and selective and
inhibits glucagon-induced hyperglycemia in both rats and monkeys, and
that it also significantly lowers glucose in a mouse model of T2DM.
Additionally, LGD-6972 significantly lowered fasting and non-fasting
glucose levels in a mouse model of type 1 diabetes and also reduced
HbA1c, ketone bodies and free fatty acids. LGD-6972 also was shown in
this model to have additive effects when used in combination with
insulin therapy, suggesting it may also be useful in an insulin-sparing
regimen.
In single- and multiple-dose Phase 1 studies, LGD-6972 demonstrated
favorable safety, tolerability and pharmacokinetics in normal healthy
volunteers and in subjects with T2DM, and demonstrated a robust,
dose-dependent reduction of fasting plasma glucose1.
Baseline-adjusted glucose values showed dose-dependent effects of
LGD-6972 on subjects with T2DM with a maximal decrease of 57 mg/dL after
14 days of treatment. The robust glycemic responses were not associated
with dose-related or clinically meaningful changes in hematology,
clinical chemistry including liver enzymes and lipids, urinalysis,
electrocardiography or vital signs, and no subject experienced a
hypoglycemic event during the 14-day treatment or follow-up periods.
Safety and efficacy of LGD-6972 was evaluated in a Phase 2 clinical
study as an adjunct to diet and exercise, in subjects with T2DM
inadequately controlled on metformin monotherapy. The Phase 2 clinical
study achieved statistical significance (p<0.0001) in the primary
endpoint of change from baseline in HbA1c after 12 weeks of treatment at
all doses tested, demonstrating a robust, dose-dependent reduction in
HbA1c of 0.90%, 0.92% and 1.20% with 5 mg, 10 mg and 15 mg of LGD-6972,
respectively, compared to a 0.15% reduction with placebo. LGD-6972 was
safe and well tolerated, with no drug-related serious adverse events and
no dose-dependent changes in lipids (including total cholesterol, LDL
cholesterol, HDL cholesterol and triglycerides), body weight or blood
pressure after 12 weeks of treatment.
About Roivant Sciences
Roivant is dedicated to transformative innovation in healthcare. Roivant
focuses on realizing the full potential of promising biomedical research
by developing and commercializing novel therapies across diverse
therapeutic areas. Roivant partners with innovative biopharmaceutical
companies and academic institutions to ensure that important medicines
are rapidly developed and delivered to patients.
Roivant advances its drug pipelines through wholly- or majority-owned
subsidiary companies, including Myovant (women’s health and endocrine
diseases), Axovant (neurology), Urovant (urology), Enzyvant (rare
diseases), Dermavant (dermatology) and Metavant (cardiometabolic
diseases). Roivant also pursues its mission by incubating and launching
innovative healthcare companies operating outside of traditional
biopharmaceutical development, including Datavant (healthcare analytics).
Roivant’s long-range mission is to reduce the time and cost of
developing and delivering new medicines for patients. For more
information, please visit www.roivant.com.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on developing or acquiring
technologies that help pharmaceutical companies discover and develop
medicines. Our business model creates value for stockholders by
providing a diversified portfolio of biotech and pharmaceutical product
revenue streams that are supported by an efficient and low corporate
cost structure. Our goal is to offer investors an opportunity to
participate in the promise of the biotech industry in a profitable,
diversified and lower-risk business than a typical biotech company. Our
business model is based on doing what we do best: drug discovery,
early-stage drug development, product reformulation and partnering. We
partner with other pharmaceutical companies to leverage what they do
best (late-stage development, regulatory management and
commercialization) to ultimately generate our revenue. Ligand’s Captisol®
platform technology is a patent-protected, chemically modified
cyclodextrin with a structure designed to optimize the solubility and
stability of drugs. OmniAb® is a patent-protected transgenic
animal platform used in the discovery of fully human mono-and bispecific
therapeutic antibodies. Ligand has established multiple alliances,
licenses and other business relationships with the world's leading
pharmaceutical companies including Novartis, Amgen, Merck, Pfizer,
Celgene, Gilead, Janssen, Baxter International and Eli Lilly.
Follow Ligand on Twitter @Ligand_LGND.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand that
involve risks and uncertainties and reflect Ligand's judgment as of the
date of this release. These forward-looking statements include comments
regarding Roivant’s plans to develop LGD-6972; potential payments to
Ligand pursuant to the license agreement with Roivant, including the
timing of the upfront license fees; the possibility that LGD-6972 could
become Ligand’s largest financial asset; Roivant’s plans to acquire
additional assets related to metabolic diseases or to hire additional
managers of Metavant; the reporting of additional results from the Phase
2 study at the American Diabetes Association’s meeting in June 2018; the
potential for LGD-6972 to have best-in-class properties to treat
patients with T2DM; whether the Phase 2 study results warrants further
clinical evaluation and advancement; and the need for new mechanisms to
treat diabetes. Actual results may differ from such forward-looking
statements due to risks and uncertainties which may be beyond Ligand’s
control, including Roivant may abandon LGD-6972 for any reason and
either party may terminate the license agreement; Ligand will be
dependent on Roivant to develop LGD-6972 which will be out of Ligand’s
control; the inherent uncertainty in any drug development program which
could fail for a number of reasons beyond our control; the timing of
reporting additional details from the Phase 2 study which may be
delayed; costs and timing of future clinical trials; the ability of
Roivant to enroll patients in a new clinical trial; the expectation that
the results from completed clinical trials predict the results of future
clinical trials; and as the growth of the population with diabetes and
the trends in the market to treat diabetes may not be in line with
Ligand’s expectations. The failure to meet expectations with respect to
any of the foregoing matters may reduce Ligand's stock price. Additional
information concerning these and other important risk factors affecting
Ligand can be found in Ligand's prior press releases available at www.ligand.com
as well as in Ligand's public periodic filings with the Securities and
Exchange Commission, available at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this press release, except
as required by law. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
References
-
Eric G. Vajda, et al. Pharmacokinetics and pharmacodynamics of single
and multiple doses of the glucagon receptor antagonist LGD-6972 in
healthy subjects and subjects with type 2 diabetes mellitus, Diabetes
Obes Metab 2017; 19(1):24–32.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180306006683/en/
Ligand Pharmaceuticals Incorporated
Todd Pettingill
(858)
550-7893
investors@ligand.com
or
LHA
Investor Relations
Bruce Voss
(310) 691-7100
bvoss@lhai.com
Source: Ligand Pharmaceuticals Incorporated
Released March 6, 2018