Ligand to Receive Milestone and Royalties as Result of FDA Approval of Sage Therapeutics’ ZULRESSO™ (brexanolone) Injection
ZULRESSO is the first and only treatment specifically indicated for
postpartum depression
SAN DIEGO--(BUSINESS WIRE)--
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190321005347/en/
Ligand Pharmaceuticals Incorporated
Todd Pettingill
investors@ligand.com
(858)
550-7893
@Ligand_LGND
LHA
Bruce Voss
bvoss@lhai.com
(310)
691-7100
Source: Ligand Pharmaceuticals Incorporated
Released March 21, 2019