Ligand’s Partner Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT™ for the Treatment of Status Epilepticus in Ad...
November 06 2020 - 2:16PM
Business Wire
Captisol-enabled™ product is stable at room
temperature for timely administration at the point of patient
care
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today
announced that its partner Sedor Pharmaceuticals, LLC has received
approval from the U.S. Food and Drug Administration (FDA) for
SESQUIENT, a Captisol-enabled™ Fosphenytoin (fosphenytoin sodium
for injection) for the treatment of status epilepticus in adult and
pediatric patients.
Ready-to-dilute and room temperature stable, SESQUIENT is the
only FDA-approved fosphenytoin that allows point-of-care storage,
as well as fast and efficient administration in emergency rooms,
intensive care units, first responder vehicles and long-term care
facilities, where serial seizures such as status epilepticus are
most commonly treated. Sedor is actively engaged in discussions to
license commercial rights to SESQUIENT for North America, Europe
and other territories except for China, where it has already been
licensed.
“We are pleased to see Sedor’s progress with SESQUIENT and
today’s FDA approval for another Captisol-based medicine,” said
John Higgins, CEO Ligand Pharmaceuticals. “Our partners at Sedor
are a dedicated and determined team that has taken Ligand’s
promising initial product concept and advanced it to a first
regulatory success. Like many other drugs, Captisol plays an
important role in the formulation of this drug for IV
administration to patients undergoing status epilepticus seizures.
This has been an extraordinary year of clinical, regulatory and
financial achievements for our Captisol business, and we are proud
to see another product advance successfully through the FDA
process.”
About SESQUIENT
SESQUIENT™ (fosphenytoin sodium for injection) is the only
FDA-approved room-temperature stable formulation of fosphenytoin
sodium. It is FDA approved for adult and pediatric use in the U.S.
to treat generalized tonic-clonic status epilepticus, the
prevention and treatment of seizures occurring during neurosurgery
and for substitution short-term use in place of oral phenytoin,
when oral phenytoin administration is not possible. More
information can be found at www.sedorpharmaceuticals.com.
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 Gilead’s VEKLURY®, Amgen’s
KYPROLIS®, Baxter International’s NEXTERONE®,
Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’
EVOMELA®, Melinta Therapeutics’ BAXDELA™ and Sage
Therapeutics’ ZULRESSO™. There are many Captisol-enabled products
currently in various stages of development. Ligand maintains a
broad global patent portfolio for Captisol with more than 400
issued patents worldwide relating to the technology (including 37
in the U.S.) and with the latest expiration date in 2033. Other
patent applications covering methods of making Captisol, if issued,
extend to 2040.
About Sedor Pharmaceuticals, LLC
Sedor Pharmaceuticals, LLC identifies, acquires and develops
acute care pharmaceutical assets for commercial licensing. The
Company is led by Chairman and CEO John Sedor and an experienced
team of pharmaceutical professionals, all possessing a proven track
record of building pharmaceutical companies and creating
shareholder value. The company’s lead product, SESQUIENT, has
received FDA approval for the treatment of status epilepticus. The
company is preparing to enter Phase I development of its second
product, Meloxicam for injection solubilized with betadex
sulfobutyl ether sodium, for the potential treatment of acute
post-surgical pain. If approved, it could possibly replace or delay
the use of IM/IV opioids. Both products were licensed from Ligand
Pharmaceuticals.
About Ligand
Ligand is a revenue-generating biopharmaceutical company focused
on developing or acquiring technologies that help pharmaceutical
companies discover and develop medicines. Ligand’s 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.
Ligand’s 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. Ligand’s
business model is based on doing what Ligand does best: drug
discovery, early-stage drug development, product reformulation and
partnering. Ligand partners with other pharmaceutical companies to
leverage what they do best (late-stage development, regulatory
management and commercialization) to ultimately generate our
revenue. Ligand’s OmniAb® technology platform is a patent-protected
transgenic animal platform used in the discovery of fully human
mono- and bispecific therapeutic antibodies. The Captisol platform
technology is a patent-protected, chemically modified cyclodextrin
with a structure designed to optimize the solubility and stability
of drugs. Ligand’s Protein Expression Technology® is a robust,
validated, cost-effective and scalable approach to recombinant
protein production, and is especially well-suited for complex,
large-scale protein production that cannot be made by more
traditional systems. Ab Initio™ technology and services for the
design and preparation of customized antigens enable the successful
discovery of therapeutic antibodies against difficult-to-access
cellular targets. Ligand has established multiple alliances,
licenses and other business relationships with the world’s leading
pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi,
Janssen, Takeda, Gilead Sciences and Baxter International. For more
information, please visit www.ligand.com.
Follow Ligand on Twitter @Ligand_LGND.
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version on businesswire.com: https://www.businesswire.com/news/home/20201106005526/en/
Ligand Pharmaceuticals Incorporated Patrick O’Brien
investors@ligand.com (858) 550-7893 Twitter: @Ligand_LGND
LHA Investor Relations Bruce Voss bvoss@lhai.com (310)
691-7100
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