Ligand Earns Milestone from SAGE Therapeutics for SAGE-547
Milestone triggered by start of Phase 3 clinical program for treatment
of super-refractory status epilepticus
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today
announced that it has earned a $500,000 milestone payment from SAGE
Therapeutics (SAGE) relating to the treatment of the first patient in
SAGE’s Phase 3 open-label expanded access protocol, designated Study
302. Study 302 is designed to offer SAGE-547 to patients affected by
super-refractory status epilepticus (SRSE) and to evaluate the safety of
SAGE-547 in patients with SRSE. SAGE has reported that the results from
this clinical trial, along with results from SAGE's planned Phase 3
placebo-controlled clinical trial - called the STATUS Trial – and other
clinical data obtained from the SAGE-547 development program are
intended to form the basis of a New Drug Application (NDA) submission.
Ligand entered into a Captisol license agreement with SAGE for the
development and commercialization of SAGE-547 in 2011. SAGE-547 is in
development by SAGE Therapeutics for the treatment of SRSE.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin with a
structure designed to optimize the solubility and stability of drugs.
Captisol was invented and initially developed by scientists in the
laboratories of Dr. Valentino Stella at the University of Kansas’
Higuchi Biosciences Center for specific use in drug development and
formulation. This unique technology has enabled seven FDA-approved
products, including Amgen’s Kyprolis®, Baxter International’s Nexterone®
and Merck’s NOXAFIL IV. There are more than 30 Captisol-enabled products
currently in clinical development.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company with a business model focused on
developing or acquiring royalty generating assets and coupling them with
a lean corporate cost structure. Ligand’s goal is to produce a bottom
line that supports a sustainably profitable business. By diversifying
the portfolio of assets across numerous technology types, therapeutic
areas, drug targets and industry partners, we offer investors an
opportunity to invest in the increasingly complicated and unpredictable
pharmaceutical industry. In comparison to its peers, we believe Ligand
has assembled one of the largest and most diversified asset portfolios
in the industry with the potential to generate revenue in the future.
These therapies seek to address the unmet medical needs of patients for
a broad spectrum of diseases including diabetes, hepatitis, muscle
wasting, Alzheimer’s disease, dyslipidemia, anemia, asthma 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 Novartis, Amgen Inc., Merck, Pfizer, Baxter
International and Eli Lilly & Co. 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 forward-looking statements include comments
regarding SAGE-547 and other drug candidates, data analysis and
evaluation of SAGE-547, utility or potential benefits to patients, the
potential commercial market for SAGE-547 and plans for continued
development and further studies of SAGE-547. Actual events or results
may differ from Ligand’s expectations. For example, there can be no
assurance that other trials or evaluations of SAGE-547 or other product
candidates 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 SAGE-547 or other product candidates
will provide utility or benefits to certain patients, that any
presentations will be favorably received, that SAGE-547 or other product
candidates will be useful, that marketing applications will be filed or,
if filed, approved, or that clinical or commercial development of these
product candidates will be initiated, completed or successful or that
our rights relating to Captisol, SAGE-547 and other related product
candidates 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 can be found in prior press releases
available at www.ligand.com
as well as in 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. 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
investors@ligand.com
(858)
550-7500
@Ligand_LGND
or
LHA
Bruce Voss
bvoss@lhai.com
(310)
691-7100
@LHA_IR_PR
Source: Ligand Pharmaceuticals
Released April 22, 2015