Ligand Announces its Captisol Business is Positioned for Major Growth and Forecasts 2021 Captisol Material Sales of $200 Mill...
September 23 2020 - 8:00AM
Business Wire
Recent partner contracts and manufacturing
investments have Captisol business operating at record high
levels
Continued clinical progress of Captisol-enabled
drugs affirms the value of the proprietary technology
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces
that recent new contracting with partners and investments in
manufacturing capacity have contributed to its Captisol business
operating at the highest levels in the history of the technology
and position Captisol for major growth. Significant new clinical
and regulatory developments with Evomela and Kyprolis, among other
drugs, are reinforcing the role the proprietary technology serves
in enabling important medicines. During 2020, Ligand has
facilitated the successful installation of equipment to allow
production at significantly higher levels to support anticipated
demand. In addition to manufacturing at partner Hovione’s
facilities in Ireland and Portugal, Ligand has now added final step
processing capacity for Captisol in both the United States and
England. Ligand also introduces guidance for 2021 Captisol material
sales of approximately $200 million.
“The global medical need for Captisol-enabled drugs has never
been higher,” said John Higgins, Chief Executive Officer of Ligand.
“Our recently expanded operating team has successfully positioned
our Captisol technology for the substantial growth we now expect in
2021 and beyond. There is significant ongoing investment by our
partners for over 30 Captisol-enabled medicines in clinical
development. We have entered into more contracts this year than any
other year and are proud to be working closely with Gilead under
our recently extended 10-year supply contract. We continue to be
pleased with the momentum relating to Captisol, as it is a critical
component in multiple life-saving medicines.”
Recent Captisol technology business highlights include the
following:
- To date in 2020 Ligand has entered into more than 120 Captisol
research use agreements and eight clinical and/or commercial
license agreements. This is the highest number of use agreements to
be signed in a single year since the invention of Captisol.
- Captisol is utilized in the formulation of Gilead Sciences’
Veklury® (remdesivir), which has received emergency use
authorizations or regulatory approvals for the treatment of
moderate or severe COVID-19 in over 50 countries and is included in
more than 30 ongoing clinical trials. Ligand is supplying Captisol
to Gilead and the company’s voluntary licensing partners who are
supplying generic remdesivir to 127 low- and middle-income
countries. Ligand expects Captisol orders into 2021 and beyond to
Gilead and its partners to help countries around the world manage
the pandemic.
- Ligand recently extended its Captisol supply agreement with
Gilead until September 2030. The contract defines terms and
conditions for forecasting, supply, order commitments and
price.
- Ligand’s manufacturing partner Hovione announced today that to
meet Captisol demand associated with Veklury, Hovione will soon be
producing more Captisol per month than it usually produces per
year. “This spike in demand has required unique mobilization
efforts across the Hovione network to secure additional raw
material supply, execute major capital expenditure projects at
oursites, maximize operational efficiency, hire additional talent
and identify external partners to expand our overall capacity. The
pharmaceutical supply chain is working together in an unprecedented
fashion to treat patients and save lives. Hovione is privileged to
be part of this truly global rapid response,” said Jean-Luc
Herbeaux, Chief Operating Officer of Hovione.
- Recent clinical data have been announced including publication
of a study from the Medical College of Wisconsin that compared
safety parameters for Captisol-enabled Evomela® versus
Alkeran® in patients undergoing autologous stem cell
transplantation for the treatment of multiple myeloma. The study of
294 patients demonstrated a statistically significant reduction in
30-day re-hospitalization rates for patients treated with Evomela
(6.8% for Evomela vs. 17.9% for Alkeran, p=0.04)a with a similar
safety profile to Alkeran. Evomela is marketed by Acrotech
Biopharma in the U.S. and by CASI Pharmaceuticals in China.
- Partner Marinus was recently awarded a BARDA contract by the
U.S. government to develop Captisol-enabled IV ganaxolone for the
treatment of refractory status epilepticus caused by nerve agent
exposure.
- Ligand’s pivotal trial for Captisol-enabled Iohexol
(CE-Iohexol) is planned to initiate in December 2020. CE-Iohexol is
an iodine-based contrast agent for hospital-based imaging
procedures. The market for iodinated contrast agents is substantial
with approximately 20 million imaging procedures per year in the
U.S., representing an estimated $1.5 billion in sales. The
objective of the clinical trial will be to demonstrate a reduction
in the incidence of contrast-induced acute kidney injury and an
equivalent image quality compared to GE’s Omnipaque®. The trial is
expected to enroll approximately 500 patients and results are
expected within two years.
Ligand’s forecast for 2021 Captisol material sales of
approximately $200 million is based on information it has on
anticipated demand from its major partners given growth in existing
and new markets, clinical requirements for Captisol-enabled
development programs and binding orders from certain commercial or
pre-commercial partners. The 2021 Captisol outlook compares with
the Company’s guidance for 2020 Captisol material sales of
approximately $90 million.
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 Pharmaceuticals
Ligand is a revenue-generating 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
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
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. Icagen has
established deep biological expertise focused on ion channels and
transporters and has a strong track record in ion channel drug
discovery from screening to lead optimization. Ligand has
established multiple alliances, licenses and other business
relationships with the world’s leading pharmaceutical companies
including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Servier,
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 expectation that Captisol demand will increase
significantly in 2021 and beyond (particularly for sales to Gilead
and to partners in Gilead’s consortium) and Ligand’s ability to
supply Captisol to Gilead and other partners, including Ligand’s
ability to increase supply capacity; the timing of initiation,
enrollment and expected results with respect to the planned
clinical trial of CE-Iohexol; and guidance regarding Ligand’s 2020
and 2021 Captisol material sales. 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; 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; Ligand may
not achieve its Captisol material sales guidance for 2020 and/or
2021; remdesivir may be later shown to not be effective or safe for
the treatment of COVID-19 and/or the FDA (and/or equivalent
agencies in other countries) may revise or revoke its emergency use
authorization for remdesivir for the treatment of COVID-19 in
patients hospitalized with moderate or severe disease if the FDA
(and/or another such agency) determines that authorization no
longer meets the statutory criteria for issuance; 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 may be unable to
scale-up the supply of Captisol or at acceptable prices; 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; Amgen, Acrotech Biopharma or other Ligand
partners may not execute on their sales and marketing plans for
marketed products for which Ligand has an economic interest; 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; Ligand may not generate expected
revenues under its existing license agreements and may experience
significant costs as the result of potential delays under its
supply agreements; Ligand and its Captisol partners may experience
delays in the commencement, enrollment, completion or analysis of
clinical testing for product candidates, or significant issues
regarding the adequacy of clinical trial designs or the execution
of clinical trials, which could result in increased costs and
delays, or limit the ability to obtain regulatory approval;
unexpected adverse side effects or inadequate therapeutic efficacy
of Ligand's or its Captisol partners’ product(s) could delay or
prevent regulatory approval or commercialization; and ongoing or
future litigation could expose Ligand to significant liabilities
and have a material adverse effect on the company. 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 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.
a Monahan, et al. Biology of Blood and Marrow Transplantation,
September 2020
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version on businesswire.com: https://www.businesswire.com/news/home/20200923005317/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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