Ligand to Receive Milestone and Royalties as Result of FDA Approval of Sage Therapeutics’ ZULRESSO™ (brexanolone) Injection
March 21 2019 - 9:00AM
Business Wire
ZULRESSO is the first and only treatment
specifically indicated for postpartum depression
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announced that it will receive a $3 million milestone payment as a
result of the U.S. Food and Drug Administration’s (FDA) approval of
Sage Therapeutics’ (NASDAQ: SAGE) ZULRESSOTM (brexanolone)
injection for the treatment of postpartum depression (PPD).
ZULRESSO uses Ligand’s Captisol® in its formulation. Ligand is also
eligible to receive a royalty on sales of ZULRESSO in the U.S.
ZULRESSO is the first and only medicine specifically approved to
treat PPD, the most common medical complication of childbirth.
ZULRESSO is expected to be available in late June following
scheduling by the U.S. Drug Enforcement Administration, which is
expected to occur within 90 days.
PPD can affect women during pregnancy or after childbirth. It is
estimated PPD affects approximately one in nine women who have
given birth in the U.S. Symptoms may include sadness, anxiety,
irritability, withdrawing from friends or family, having trouble
bonding with her baby and thinking about harming herself or more
rarely, her baby. Without proper screening, up to half of PPD cases
may go undiagnosed.
About Postpartum Depression
Postpartum depression (PPD) is the most common medical
complication of childbirth. PPD is a distinct and readily
identified major depressive disorder that can occur during
pregnancy or after giving birth. Expert opinions vary as to the
timing of the onset of PPD, ranging from onset during pregnancy up
to 4-weeks postpartum and onset during pregnancy up to 12-months
postpartum. PPD may have devastating consequences for a woman and
for her family, which may include significant functional
impairment, depressed mood and/or loss of interest in her newborn,
and associated symptoms of depression such as loss of appetite,
difficulty sleeping, motor challenges, lack of concentration, loss
of energy and poor self-esteem. Suicide is the leading cause of
maternal death following childbirth. PPD affects approximately one
in nine women who have given birth in the U.S. and 400,000 women
annually. More than half of these cases may go undiagnosed without
proper screening.
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, University
Distinguished Professor at the University of Kansas’ Higuchi
Biosciences Center for specific use in drug development and
formulation. This unique technology has enabled several
FDA-approved products, including Amgen’s Kyprolis®, Baxter
International’s Nexterone®, Spectrum’s EVOMELA® and Melinta
Therapeutics’ Baxdela™. There are many Captisol-enabled products
currently in various stages of development.
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 include statements regarding:
the expectations regarding scheduling and future availability of
ZULRESSO in the treatment of PPD; the statements regarding the
potential for ZULRESSO to rapidly resolve PPD symptoms; estimates
as to the number of women with PPD in the U.S. and rates of
diagnosis; and the amount and timing of the milestone payment or
royalty payments to be received by Ligand. All statements regarding
ZULRESSO and PPD in this press release come from public statements
made by Sage Therapeutics and Ligand has not independently verified
such information. Actual events or results may differ from our
expectations. For example, the Drug Enforcement Administration
scheduling and launch of ZULRESSO may not occur on the timelines
reported by Sage; Sage may encounter issues, delays or other
challenges in launching or commercializing ZULRESSO, including
issues related to market acceptance and reimbursement, challenges
related to limiting the site of administration of the product to a
certified healthcare facility monitored by a qualified healthcare
provider, and the necessity for a Risk Evaluation and Mitigation
Strategies plan; challenges associated with execution of Sage’s
sales and patient support activities, which in each case could
limit the potential of Sage’s product; results achieved with
ZULRESSO in the treatment of PPD once Sage has launched the product
may be different than observed in clinical trials, and may vary
among patients; Sage may encounter unexpected safety or
tolerability issues with ZULRESSO; the number of patients with PPD
or the unmet need for additional treatment options may be
significantly smaller than Sage has reported; success in early
stage clinical trials may not be repeated or observed in ongoing or
future clinical trials; and Sage may encounter technical and other
unexpected hurdles in the commercialization of ZULRESSO. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190321005347/en/
Ligand Pharmaceuticals IncorporatedTodd
Pettingillinvestors@ligand.com(858) 550-7893@Ligand_LGNDLHABruce
Vossbvoss@lhai.com(310) 691-7100
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