LGND Ligand Pharmaceuticals Incorporated

95.32
-0.48  -1%
Previous Close 95.8
Open 95.78
52 Week Low 57.24
52 Week High 127.8
Market Cap $1,532,568,591
Shares 16,078,143
Float 11,212,772
Enterprise Value $1,190,183,192
Volume 149,092
Av. Daily Volume 256,447
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Upcoming Catalysts

Drug Stage Catalyst Date
KYPROLIS (ARROW)
Multiple Myeloma
Approved
Approved
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Sparsentan - DUPLEX
Focal segmental glomerulosclerosis (FSGS)
Phase 3
Phase 3
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SB206 - B-SIMPLE4
Molluscum
Phase 3
Phase 3
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Ensifentrine (RPL554) - Metered Dose Inhaler
Maintenance treatment of COPD
Phase 2
Phase 2
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Sparsentan
IgA nephropathy
Phase 3
Phase 3
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Ganaxolone
Refractory status epilepticus (RSE)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Ensifentrine (RPL554) - (ENHANCE-1 and ENHANCE-2)
Chronic obstructive pulmonary disease (COPD)
Phase 3
Phase 3
Phase 3 trial initiation announced September 23, 2020.
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - September 14, 2020.
APVO436
Acute myeloid leukemia (AML)
Phase 1
Phase 1
Phase 1 trial ongoing. Dosing in cohorts 1 through 6 has been completed.
Ganaxolone - Magnolia
Postpartum depression
Phase 2
Phase 2
Phase 2 negative data released July 23, 2019.
VK2809 VOYAGE
Non-alcoholic steatohepatitis (NASH) and fibrosis
Phase 2b
Phase 2b
Phase 2b enrolment to be completed 1H 2021.
RPL554 DPI formulation
Maintenance treatment of COPD
Phase 2
Phase 2
Phase 2 data met primary endpoint - August 5, 2019.
CS1001
Gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma.
Phase 3
Phase 3
Phase 3 trial has been initiated by partner CStone Pharmaceuticals.
Captisol-enabled (CE) Iohexol program
Contrast-induced Nephropathy
Phase 1
Phase 1
Phase 1 top-line data met primary endpoint - July 10, 2019.
VK5211
Acute Hip Fracture
Phase 2
Phase 2
Phase 2 trial met endpoints - November 28, 2017. Data at ASBMR September 30, 2018.
Brexanolone - SAGE-547 (202C)
Postpartum Depression - moderate
Approved
Approved
FDA approval announced March 19, 2018.
KYPROLIS (ASPIRE)
Relapsed Multiple Myeloma
Approved
Approved
sNDA approval announced June 11, 2018.
KYPROLIS (ENDEAVOR)
Relapsed Multiple Myeloma
Approved
Approved
sNDA approved January 17, 2018.
RPL554
Cystic fibrosis
Phase 2a
Phase 2a
Phase 2a data released March 2, 2018.
Ganaxolone
Fragile X Syndrome
Phase 2
Phase 2
Phase 2 data released June 2016. Primary endpoint not met but intends to advance development

Latest News

  1. COLUMBUS, Ohio, Sept. 30, 2020 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female oncology products in the precision medicine metastatic breast cancer arena, today announced a collaboration with Exactis Innovation, a pan-Canadian Network of Centres of Excellence (NCE) in precision medicine, expanding a Phase 2 clinical trial of Sermonix's lead investigational drug, lasofoxifene, into Canada.

    The NCE is a Canadian government initiative that funds partnerships between universities, industry, government and not-for-profit organizations to create large-scale research networks integrating precision oncology across Canada.

    With the recent Health Canada agreement to…

    COLUMBUS, Ohio, Sept. 30, 2020 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female oncology products in the precision medicine metastatic breast cancer arena, today announced a collaboration with Exactis Innovation, a pan-Canadian Network of Centres of Excellence (NCE) in precision medicine, expanding a Phase 2 clinical trial of Sermonix's lead investigational drug, lasofoxifene, into Canada.

    The NCE is a Canadian government initiative that funds partnerships between universities, industry, government and not-for-profit organizations to create large-scale research networks integrating precision oncology across Canada.

    With the recent Health Canada agreement to proceed, the open-label, randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study will now include Exactis Network sites in Quebec, Ontario, Nova Scotia and New Brunswick. The study, which began U.S. enrollment in September 2019, is assessing the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.

    "Sermonix is honored to collaborate with Exactis Innovation, a truly esteemed international center of excellence in precision medicine," said David Portman, Sermonix founder and chief executive officer. "Our ELAINE trials are solely focused on women with ESR1 mutations, for whom there is such great need of targeted treatments that potentially can prolong and enhance their lives. Working with Exactis furthers that mission."

    With exclusive global rights to develop and commercialize lasofoxifene in the oncological arena, Sermonix is also adding ELAINE 1 study sites in Israel, further providing important international data as the company looks to fulfill its global mission of addressing the unmet needs of women with metastatic breast cancer.

    Personalize My Treatment

    Personalize My Treatment (PMT) is Exactis' active pan-Canadian, Research Ethics Board-approved cancer patient registry that collects clinical and molecular patient data to match sub-populations in precision oncology research. Exactis will utilize its PMT registry, pre-screening patients to identify ESR1 mutations to both inform genomic cancer profiling during the patient's treatment journey and potentially identify candidates for the ELAINE trial participation.

    Exactis Chief Medical Officer Dr. Gerald Batist will work closely with Sermonix on the PMT/ELAINE collaboration. Dr. Batist is currently professor and former chair of the Department of Oncology at McGill University and is director of both the McGill Centre for Translational Research in Cancer and the Segal Cancer Centre at Sir Mortimer B. Davis-Jewish General Hospital in Montreal.

    "The synergy between Sermonix's precision medicine focus – through its ELAINE 1 study of lasofoxifene – and the Exactis network and PMT registry creates an ideal collaborative opportunity," said Dr. Batist. "We look forward to identifying and enrolling Canadian women into this trial, extending the frontier of research in the ESR1-mutated breast cancer arena and offering Canadian patients participation in this very promising clinical trial."

    About Lasofoxifene

    Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene's bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene's novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

    About Sermonix

    Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking two Phase 2 clinical studies of lasofoxifene, its lead investigational drug. Sermonix Pharmaceuticals was founded in 2014 by David Portman, M.D., a leading clinical researcher and expert in women's health, menopause and selective estrogen receptor modulator (SERM) therapy. The Sermonix management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience in the oncology drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in SERM biology. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D. vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division. Learn more at https://sermonixpharma.com/.

    Contact information:

    David Portman, MD

    CEO and Founder, Sermonix Pharmaceuticals

     

    614-582-6849

    Primary Logo

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  2. Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced that its tender offer to purchase any and all issued and outstanding shares of common stock of Pfenex Inc. (NYSE:PFNX) at an offer price of $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved, expired at midnight (New York City time), at the end of the day on Tuesday, September 29, 2020.

    The depositary for the tender offer has advised that, as of the expiration of the tender offer, a total of approximately 27,591,554 shares were validly tendered and not withdrawn in the tender offer (including shares delivered through…

    Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced that its tender offer to purchase any and all issued and outstanding shares of common stock of Pfenex Inc. (NYSE:PFNX) at an offer price of $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved, expired at midnight (New York City time), at the end of the day on Tuesday, September 29, 2020.

    The depositary for the tender offer has advised that, as of the expiration of the tender offer, a total of approximately 27,591,554 shares were validly tendered and not withdrawn in the tender offer (including shares delivered through notices of guaranteed delivery), representing approximately 80.3% of Pfenex's outstanding shares. Ligand's wholly-owned subsidiary will accept for payment all shares that were validly tendered and not withdrawn prior to expiration of the tender offer, and payment for such shares will be made promptly, in accordance with the terms of the tender offer.

    Ligand expects the merger to close on October 1, 2020, with Pfenex becoming a wholly owned subsidiary of Ligand. As a consequence of the merger, each outstanding Pfenex share not tendered and purchased in the offer (other than those as to which holders properly exercise dissenters' rights and those owned at the commencement of the tender offer by Ligand or its direct and indirect subsidiaries) will be converted into the right to receive the same $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved, without interest and less any required withholding taxes, that was offered in the tender offer. Following completion of the merger, Pfenex's common stock will cease to be traded on the New York Stock Exchange American.

    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 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, Servier, Gilead Sciences and Baxter International. For more information, please visit www.ligand.com.

    Follow Ligand on Twitter @Ligand_LGND.

    Cautionary Statement Regarding Forward-Looking Statements

    This press 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 forward-looking statements include, without limitation, statements regarding the timing of the anticipated acquisition and when and whether the anticipated acquisition ultimately will close. Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligand's business, including, without limitation: the risk that the conditions to the closing of the transaction are not satisfied; litigation relating to the transaction; uncertainties as to the timing of the consummation of the transaction and the ability of each of Ligand or Pfenex to consummate the transaction; risks that the proposed transaction disrupts the current plans and operations of Ligand or Pfenex; the ability of Pfenex to retain key personnel; competitive responses to the proposed transaction; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; Ligand's ability to achieve the growth prospects and synergies expected from the transaction, as well as delays, challenges and expenses associated with integrating Pfenex with its existing businesses; the impact of COVID-19 on Ligand's and Pfenex's businesses and the timing of the transaction; legislative, regulatory and economic developments; and other risks described in Ligand's prior press releases and filings with the SEC. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Ligand disclaims any intent or obligation to update these forward-looking statements after the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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    • Pfizer to invest $200 million in CStone shares and license CStone's late-stage oncology asset sugemalimab (CS1001, PD-L1 antibody) in mainland China
    • CStone to receive up to $280 million in milestone payments for sugemalimab, and additional royalties
    • CStone and Pfizer to develop and commercialize additional late-stage oncology therapies in Greater China

    CStone Pharmaceuticals ("CStone", HKEX: 2616)] and Pfizer Investment Co. Ltd. ("Pfizer Investment") and Pfizer Corporation Hong Kong Limited ("Pfizer Hong Kong") (both of which are subsidiaries of Pfizer Inc. (NYSE: PFE)) announced today the formation of a strategic collaboration that encompasses a $200 million equity investment by Pfizer Hong Kong in CStone, collaboration between CStone…

    • Pfizer to invest $200 million in CStone shares and license CStone's late-stage oncology asset sugemalimab (CS1001, PD-L1 antibody) in mainland China
    • CStone to receive up to $280 million in milestone payments for sugemalimab, and additional royalties
    • CStone and Pfizer to develop and commercialize additional late-stage oncology therapies in Greater China

    CStone Pharmaceuticals ("CStone", HKEX: 2616)] and Pfizer Investment Co. Ltd. ("Pfizer Investment") and Pfizer Corporation Hong Kong Limited ("Pfizer Hong Kong") (both of which are subsidiaries of Pfizer Inc. (NYSE: PFE)) announced today the formation of a strategic collaboration that encompasses a $200 million equity investment by Pfizer Hong Kong in CStone, collaboration between CStone and Pfizer Investment for the development and commercialization of CStone's sugemalimab (CS1001, PD-L1 antibody) in mainland China, and a framework between CStone and Pfizer Investment to bring additional oncology assets to the Greater China market.

    This collaboration provides financing to support CStone's development of sugemalimab, a potential best-in-class PD-L1 antibody that is being developed for high-incidence cancer indications in China, including lung, gastric and esophageal cancers, among others. Pfizer will in-license and exclusively lead commercialization of sugemalimab in China, harnessing its industry-leading capabilities to help doctors and patients across a far wider range of regions gain greater access to this treatment. The collaboration positions CStone and Pfizer to develop and commercialize additional oncology assets for the Greater China market.

    "Pfizer's investment in CStone is a statement of its confidence in the potential of our anti-PD-L1 treatment and recognition of our research and development capabilities," said Frank Jiang, M.D., Ph.D., Chairman and Chief Executive Officer of CStone. "By joining forces with Pfizer and leveraging its commercialization infrastructure, we will ensure that patients across a vastly expanded number of markets in China have quicker access to our highly differentiated PD-L1 treatment. In addition, we have advanced our transformation into a full-fledged biopharmaceutical company by forging a collaboration that will enable us to accelerate development and commercialization of globally innovative therapies for Chinese patients."

    "Our company has an extensive and proud history of bringing innovative medicines to patients in China," said Pierre Gaudreault, Acting President of Pfizer Biopharmaceuticals Group China. "This collaboration with CStone builds on that history by helping to develop a potential best-in-class PD-L1 treatment that we can commercialize upon approval. It also fosters our collaboration with a partner that has exceptional clinical development capabilities that can help us meet the clear need for novel oncology treatments in China."

    Key Components and Financial Terms of the Collaboration

    • Pfizer obtains exclusive commercialization rights to sugemalimab in mainland China, while CStone continues to lead clinical development and regulatory strategy for five selected indications.
    • CStone is entitled to receive up to $280 million in milestone payments for sugemalimab and additional tiered royalties.
    • CStone retains all development and commercialization rights to sugemalimab outside mainland China.
    • Pfizer will invest $200 million, consisting of 115,928,803 CStone shares at a price of US$1.725 per share (approximately HK$13.37 per share). As a result of its equity investment, Pfizer will hold a 9.90 percent stake in CStone.
    • CStone and Pfizer will together select late-stage (post proof-of-concept) oncology assets for co-development in the Greater China market. These assets may come either from Pfizer's pipeline or through joint in-licensing.
    • CStone and Pfizer may pursue on a selected basis joint in-licensing arrangements for additional oncology assets for the Greater China market.

    The transaction has received the necessary internal approvals of both companies. Closing is not subject to approval by CStone's shareholders.

    Goldman Sachs & Co. LLC is acting as financial advisor to CStone, and Cooley LLP served as legal advisor. Clifford Chance LLP served as Pfizer's legal advisor.

    Investor Presentation Information

    CStone will host a live webcast at 11:00am (Hong Kong time) on September 30th, 2020. Please find the access information as below.

    All other regions: https://event.webcasts.com/starthere.jsp?ei=1380037&tp_key=735ccdf3e4

    Mainland China: https://event.gmwebcasts.cn/starthere.jsp?ei=1380037&tp_key=735ccdf3e4

    Password (case sensitive): CStone

    About Sugemalimab

    Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by a company based in the U.S., Ligand Pharmaceuticals Inc. (NASDAQ:LGND), sugemalimab is developed using the OmniRat® transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 ("IgG4") human antibody, which may reduce the risk of immunogenicity and toxicities in patients, a potentially unique advantage over similar drugs.

    Sugemalimab has completed a Phase I dose-escalation study in China. During Phase 1a and 1b stages of the study, sugemalimab showed antitumor activity in multiple tumor types and was well-tolerated.

    Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase I bridging study in the U.S., the clinical programs in China include one multi-arm Phase Ib study for several tumor types, one Phase II registrational study for lymphoma, and four Phase III registrational studies, respectively, for stage III/IV non-small cell lung cancer, gastric cancer, and esophageal cancer.

    About CStone

    CStone is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established at the end of 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. With a strategic emphasis on immuno-oncology combination therapies, the Company has built an oncology-focused pipeline of 15 drug candidates, including five late-stage candidates at pivotal trials or registration stages. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide. For more information about CStone, please visit: www.cstonepharma.com.

    About Pfizer: Breakthroughs and innovations to change the lives of patients

    At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medical and health products (including innovative drugs and vaccines) for people. Every day, Pfizer colleagues from the developed and emerging markets work to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with healthcare providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit www.pfizer.com.cn.

    Forward-looking Statement

    The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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  3. 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…

    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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  4. The acquired technologies continue to position Ligand's OmniAb as a best-in-class platform for antibody discovery

    Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announces the acquisition of two privately held companies that strengthen and complement its OmniAb® technology platform. Ligand acquired xCella Biosciences, Inc. for $7 million in cash plus potential earnouts, and acquired Taurus Biosciences LLC for $5 million in cash plus non-transferable contingent value rights (CVRs). In addition, Ligand will invest $2.5 million in a new company, Minotaur Therapeutics, which will be led by Taurus Biosciences' founder, in exchange for royalties on products from future programs.

    With the addition of these two companies, Ligand has secured a…

    The acquired technologies continue to position Ligand's OmniAb as a best-in-class platform for antibody discovery

    Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announces the acquisition of two privately held companies that strengthen and complement its OmniAb® technology platform. Ligand acquired xCella Biosciences, Inc. for $7 million in cash plus potential earnouts, and acquired Taurus Biosciences LLC for $5 million in cash plus non-transferable contingent value rights (CVRs). In addition, Ligand will invest $2.5 million in a new company, Minotaur Therapeutics, which will be led by Taurus Biosciences' founder, in exchange for royalties on products from future programs.

    With the addition of these two companies, Ligand has secured a technology to further enhance its single B cell screening platform as well as technologies to discover and humanize antibodies from immunized cows or cow-derived libraries. The acquisitions are expected to enable Ligand to secure new license agreements with expanded economics as a result of the addition of tools and intellectual property that Ligand can now offer to partners. Ligand evaluated multiple public and private platforms to acquire in order to continue the expansion of the OmniAb platform and determined xCella and Taurus represented the best fit and opportunity.

    "Bringing the capabilities and intellectual property of these two companies into Ligand will strengthen our antibody discovery capabilities, in particular our OmniChicken® platform. We are committed to keeping OmniAb at the cutting edge of antibody discovery and development, as exemplified by these deals and our acquisition of Ab Initio Biotherapeutics last year," said John Higgins, Chief Executive Officer of Ligand. "During 2020 we have seen a number of major advancements by partners with OmniAb-discovered programs. We believe the next few years will further highlight the significance of the OmniAb platform to major drug programs and contribute substantially to our financial growth and performance."

    Ligand's OmniAb antibody discovery platform has been formed via five strategic acquisitions of leading antibody discovery tools and intellectual property over the past several years, creating a best-in-class platform to serve a growing portfolio of partners, with:

    • Potential for two approvals of OmniAb-derived antibodies in 2021 with expected new royalty streams to Ligand;
    • More than 80 OmniAb-derived programs in Ligand's diverse and growing portfolio of partnerships;
    • Approximately 50 completed or on-going clinical trials with OmniAb-derived antibodies;
    • Leading OmniAb-derived programs in clinical development with Janssen/J&J (Teclistamab), Genentech (Tiragolumab), Gloria Pharmaceuticals and Arcus/Gilead (Zimberelimab), CStone Pharmaceuticals (Sugemalimab), and Immunovant (IMVT-1401).

    About xCella Biosciences

    xCella is an antibody discovery company based in Menlo Park, California, and built on scientific research from Stanford University and MIT. xCella's xPloration platform is a proprietary microcapillary platform that can screen single B cells for specificity and bioactivity and will increase Ligand's antibody discovery throughput and efficiency. This acquisition also provides Ligand with an existing partnership with Teva Pharmaceuticals. For more information, please visit www.xcellabio.com.

    About Taurus Biosciences

    Taurus Biosciences discovers and develops novel antibodies from immunized cows and cow-inspired libraries. These antibodies feature some of the longest CDR3s of any species, with unique genetic and structural diversity that can enable binding to challenging antigens with application in therapeutics, diagnostics and research. Taurus Biosciences is based in San Diego and has intellectual property, derived from major discoveries at Scripps Research and the Applied Biomedical Science Institute, related to bovine ultralong CDR3 antibodies. For more information, please visit www.taurusbiosci.com.

    About OmniAb®

    OmniAb is a three-species transgenic-animal platform consisting of five different technologies used for producing mono- and bispecific human therapeutic antibodies. OmniRat® animals comprise the industry's first human monoclonal antibody technology based on rats. Because they have a complete immune system with a diverse antibody repertoire, OmniRat animals generate antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse® is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic® is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. OmniChicken® animals comprise the industry's first human monoclonal antibody technology based on chickens. The OmniClic chicken is specifically developed to facilitate the generation of bispecific antibodies and retains the ability to generate diverse, high quality affinity matured antibodies. All five types of OmniAb therapeutic human antibody platform, OmniRat, OmniFlic, OmniMouse, OmniChicken and OmniClic, use patented technology, have broad freedom to operate, produce highly diversified, fully human antibody repertoires optimized in vivo for immunogenicity, manufacturability, and therapeutic efficacy, and deliver fully human antibodies with high affinity, specificity, expression, solubility and stability - Naturally Optimized Human Antibodies®.

    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. These forward-looking statements include, without limitation, statements regarding: the improvement of Ligand's antibody discovery capabilities and the commercial advantages that are expected to arise from such improvements. Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligand's business, including, without limitation: the OmniAb platform faces specific risks, including the fact that no product using antibodies from the platform has been approved by the FDA or similar regulatory agency; unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's or Ligand's partners' product(s) could delay or prevent regulatory approval or commercialization; and other risks described in Ligand's prior press releases and filings with the SEC. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Ligand disclaims any intent or obligation to update these forward-looking statements after the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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