Ligand’s Captisol Technology Plays Key Role in the Manufacture of Gilead’s
Veklury, the First FDA-Approved COVID-19 Treatment
Business Wire
SAN DIEGO -- October 23, 2020
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today highlighted the
company’s role in the manufacturing of Veklury^® (remdesivir), Gilead
Sciences’ antiviral drug for the treatment of patients with COVID-19 requiring
hospitalization. Veklury is formulated with Ligand’s Captisol^® technology.
Approved yesterday by the U.S. Food and Drug Administration, Veklury is the
first and only approved COVID-19 treatment in the United States. The drug is
now widely available in hospitals across the country, following Gilead’s early
investments to rapidly expand manufacturing capacity to increase supply.
“We congratulate Gilead on achieving this regulatory milestone,” said John
Higgins, Chief Executive Officer of Ligand. “Veklury is an important medicine
that has already played a vital role in the treatment of many patients with
COVID-19 worldwide. In early January Gilead contacted Ligand requesting urgent
shipments of Captisol. Over the following weeks and months, the Captisol
volume requirements and supply needs expanded significantly, and Ligand has
been there to support Gilead in their effort to manufacture millions of
treatment courses. While the progression of the pandemic was and still is
unknown, Ligand made the strategic and ethical decision to invest
significantly in scale-up to ensure we had sufficient capacity to meet the
Captisol supply needs for Gilead and members of its international
manufacturing consortium. It has been an intense nine months executing on
these efforts. We are proud of our contribution to this first and only
U.S.-approved treatment for COVID-19, and we are equally proud of our ability
to execute so efficiently and smoothly to answer the call.”
Higgins continued, “As the number of people with COVID-19 continues to
increase in most states and many countries around the world, we believe Ligand
is well positioned to meet higher levels of demand for Captisol. Supplying
Captisol for remdesivir will continue to be a top priority for the company;
however, we remain focused on executing on our strong and highly diversified
core business. As described during our recent Analyst & Investor Day, Ligand
is positioned for accelerated growth independent of any contribution from
remdesivir.”
About Veklury^®
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on
more than a decade of the company’s antiviral research. Veklury has
broad-spectrum antiviral activity both in vitro and in vivo in animal models
against multiple emerging viral pathogens, including Ebola, SARS, Marburg,
MERS and SARS-CoV-2, the virus that causes COVID-19.
Veklury has been approved or authorized for temporary use as a COVID-19
treatment in approximately 50 countries worldwide. In our continuing
commitment to develop effective treatments for COVID-19, multiple ongoing
international Phase 3 clinical trials are evaluating the safety and efficacy
of Veklury for the treatment of COVID-19, in different patient populations,
formulations, and in combination with other therapies.
As announced on October 1, 2020, Gilead is now meeting real-time demand for
Veklury in the United States and anticipates meeting global demand for Veklury
in October, even in the event of potential future surges of COVID-19.
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 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. The
Pfenex 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. The Vernalis Design Platform (VDP) integrates
protein structure determination and engineering, fragment screening and
molecular modeling, with medicinal chemistry, to help enable success in novel
drug discovery programs against highly challenging targets. 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.
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. Words such as “plans,” “believes,” “expects,” “anticipates,” and
“will,” and similar expressions, are intended to identify forward-looking
statements. These forward-looking statements include, without limitation,
statements regarding: Ligand’s ability to supply Captisol to Gilead and other
partners, including Ligand’s ability to increase supply capacity; and Ligand’s
belief it is positioned for accelerated growth independent of any contribution
from remdesivir. Actual events or results may differ from Ligand's
expectations due to risks and uncertainties inherent in Ligand’s business,
including, without limitation: Ligand may not receive expected revenue from
Captisol sales from remdesivir or otherwise; the COVID-19 pandemic has
disrupted Ligand’s and its partners’ business, including delaying
manufacturing, preclinical studies and clinical trials and product sales, and
impairing global economic activity, all of which could materially and
adversely impact Ligand’s results of operations and financial condition;
remdesivir may be later shown to not be effective or safe for the treatment of
COVID-19 and could materially and adversely affect the commercial opportunity
for remdesivir; alternative COVID-19 therapies or vaccines may be approved or
the risk of coronavirus infection could significantly diminish, any of which
could materially and adversely affect the commercial opportunity for
remdesivir; Gilead may terminate the supply agreement without cause upon 30
days’ prior written notice; Ligand is currently dependent on Hovione as a
single source sole supplier for certain Captisol manufacturing functions and
failures by such supplier may result in delays or inability to meet the
Captisol demands of its partners; Ligand or its Captisol partners may not be
able to protect their intellectual property and patents covering certain
products and technologies may be challenged or invalidated; Ligand's Captisol
partners may terminate agreements or development or commercialization of
products and other risk factors described 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 release. 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/20201023005151/en/
Contact:
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
Gloss