Ligand Partner SAGE Therapeutics Receives Fast Track Designation for Captisol-enabled SAGE-547 to Treat Status Epilepticus
Proceeds from Sage Therapeutics’ recent IPO expected to fund pipeline
including Captisol-enabled SAGE-547
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that
its partner Sage Therapeutics Inc., a biopharmaceutical company
developing novel medicines to treat life-threatening, rare central
nervous system (CNS) disorders, announced today that the U.S. Food and
Drug Administration (FDA) has granted fast track designation to the
SAGE-547 development program. SAGE-547 is an allosteric modulator of GABAA
receptors in development for the treatment of adult patients with
refractory status epilepticus who have not responded to standard
regimens (super-refractory status epilepticus, or SRSE).
SAGE is currently evaluating SAGE-547 in a Phase I/II clinical trial for
the treatment of SRSE. Preliminary data indicate that the first four
patients enrolled in the clinical trial met the key efficacy endpoint,
in that each was successfully weaned off his or her anesthetic agent
while SAGE-547 was being administered. There have also been no reported
drug-related serious adverse events in these four patients to date.
Sage also recently announced the pricing of an initial public offering
of common stock. The intended use of proceeds are described in the
related prospectus and are expected to include funding pipeline programs
including SAGE-547, an intravenous agent that utilizes Ligand’s
Captisol® technology, among other purposes.
Ligand’s partnership with Sage began in 2011 when the companies entered
into a platform Captisol license agreement for the development of
Captisol-enabled therapeutics for a broad range of debilitating central
nervous system conditions. Ligand received an upfront payment and is
eligible for future milestone payments, product royalties and revenue
from the sale of Captisol for use in clinical trials and commercial
products. Elements of the agreement with Sage were expanded in 2014.
“Sage illustrates the important role Ligand can play in helping our
partners to develop new drug candidates,” said John Higgins, President
and Chief Executive Officer of Ligand. “Whether it’s licensing our
technology such as Captisol or our novel research discoveries, by
conferring our rights under licenses, new R&D programs can advance
efficiently with dedicated resources and funding. Each of these licenses
holds potential for new medical and commercial markets to be opened up,
with Ligand participating in the economics of a successful program.”
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin with a
structure designed to optimize the solubility and stability of drugs.
The original form of Captisol was invented and initially developed by
scientists in the laboratories of Dr. Valentino Stella at the University
of Kansas’ Higuchi Biosciences Center for use in drug development and
formulation. This unique technology has enabled six FDA-approved
products, including Onyx Pharmaceuticals’ (now Amgen) Kyprolis®, Baxter
International’s Nexterone® and Merck’s NOXAFIL® IV. There are more than
30 Captisol-enabled products currently in clinical development.
About Status Epilepticus (SE)
SE is a life-threatening seizure condition that occurs in approximately
150,000 people each year in the U.S., of which 30,000 SE patients die.1
We estimate that there are 35,000 patients with SE in the U.S. that are
hospitalized in the intensive care unit (ICU) each year. An SE patient
is first treated with benzodiazepines, and if no response, is then
treated with other, second-line, anti-seizure drugs. If the seizure
persists after the second-line therapy, the patient is diagnosed as
having refractory SE (RSE), admitted to the ICU and placed into a
medically induced coma. Currently, there are no therapies that have been
specifically approved for RSE; however, physicians typically use
anesthetic agents to induce the coma and stop the seizure immediately.
After a period of 24 hours, an attempt is made to wean the patient from
the anesthetic agents to evaluate whether or not the seizure condition
has resolved. Unfortunately, not all patients respond to weaning
attempts, in which case the patient must be maintained in the medically
induced coma. At this point, the patient is diagnosed as having SRSE.
Currently, there are no therapies specifically approved for SRSE
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company with a business model that is
based upon the concept of developing or acquiring royalty revenue
generating assets and coupling them to 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 GlaxoSmithKline, Onyx
Pharmaceuticals (a subsidiary of Amgen Inc.), Merck, Pfizer, Baxter
International, 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 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,
Sage’s use of proceeds from its IPO, 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 to 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 L. Higgins, President and
CEO
(858) 550-7500
or
LHA
Bruce Voss, (310) 691-7100
bvoss@lhai.com
Source: Ligand Pharmaceuticals Incorporated
Released July 22, 2014