Ligand’s Captisol Technology Plays Key Role in the Manufacture of Gilead’s Veklury, the First FDA-Approved COVID-19 Treatment

Ligand Pharmaceuticals Incorporated 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.

John Higgins, Chief Executive Officer of Ligand Said: “We congratulate Gilead on achieving this regulatory milestone, 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.

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