Ligand Announces FDA Acceptance of Investigational New Drug Application for Glucagon Receptor Antagonist Program
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) has opened an
Investigational New Drug (IND) application with the U.S. Food and Drug
Administration (FDA) and has obtained FDA approval to initiate clinical
development for its Glucagon Receptor Antagonist program with LGD-6972
for the treatment of type 2 diabetes mellitus. The company plans to
initiate Phase I clinical testing in the fourth quarter of 2013.
“The opening of this IND is an important milestone for Ligand’s novel
glucagon receptor antagonist program, as glucagon receptor antagonism
may have a key role to play in the treatment and management of type 2
diabetes,” commented Matthew W. Foehr, Executive Vice President and
Chief Operating Officer of Ligand. “We consider this one of our most
significant unpartnered programs and look forward to beginning Phase I
clinical development. We plan to assess the partnering landscape after
the Phase I clinical trials are completed.”
About Ligand’s Glucagon Receptor Antagonist Program
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 plasma glucose levels in patients with type 2
diabetes and is believed to be due in part to inappropriately elevated
levels of glucagon. High plasma glucose levels can cause diabetic
complications such as blindness and kidney disease. Glucagon receptor
antagonists are designed to lower plasma glucose levels by reducing the
production of glucose by the liver. Glucagon receptor antagonists are
novel molecules that have demonstrated a reduction of plasma glucose and
hemoglobin A1c in patients with type 2 diabetes in mid-stage clinical
trials.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on assembling a large
portfolio of revenue generating assets through licensing and acquisition
with the goal to generate sustainable cash-flow and profitability.
Ligand has a diverse asset portfolio addressing the unmet medical needs
of patients for a broad spectrum of diseases including thrombocytopenia,
multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia,
anemia and osteoporosis. Ligand’s Captisol® platform
technology is a patent-protected, chemically modified cyclodextrin with
a structure designed to optimize the solubility and stability of drugs.
Ligand has established multiple alliances with the world's leading
pharmaceutical companies including GlaxoSmithKline, Onyx
Pharmaceuticals, Merck, Pfizer, Baxter International, Bristol-Myers
Squibb, Lundbeck Inc., Eli Lilly & Co. and Spectrum Pharmaceuticals.
Please visit www.captisol.com
for more information on Captisol and www.ligand.com
for more information on Ligand.
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 include statements regarding data analysis
and evaluation of LGD-6972 and/or other Glucagon receptor antagonists,
utility or potential benefits to patients, plans for continued
development and further studies of such compounds. Actual events or
results may differ from our expectations. For example, there can be no
assurance that the Phase I clinical trials or any other evaluations of
LGD-6972 and/or other Glucagon receptor antagonists will be favorable or
that they will confirm results of previous studies, that data evaluation
will be completed or demonstrate any hypothesis or endpoint, that such
compounds will provide utility or benefits to certain patients, that any
potential partnering opportunities would exist or be successful, that
any presentations will be favorably received, that such compounds will
be useful with other drugs, that marketing applications will be filed
or, if filed, approved, or that clinical or commercial development of
these drugs will be initiated, completed or successful or that our
rights to LGD-6972 and/or other Glucagon receptor antagonists will not
be successfully challenged. 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 risk factors affecting
Ligand's business can be found in prior press releases available via www.ligand.com
as well as in Ligand's public periodic filings with the Securities and
Exchange Commission at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this release. This caution
is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
Ligand Pharmaceuticals Incorporated
John Higgins, President and CEO
Jennifer
Capuzelo, Investor Relations
858-550-7583
jcapuzelo@ligand.com
or
LHA
Don
Markley, 310-691-7100
dmarkley@lhai.com
Source: Ligand Pharmaceuticals Incorporated
Released October 7, 2013