Hovione announced the signing of a partnership agreement with Ligand to ramp up the production output of Captisol®. A Ligand product, Captisol, is a chemically modified cyclodextrin proven to improve the solubility and stability of drugs. It is used in the formulation of Gilead’s Covid-19 treatment Veklury® (remdesivir). Hovione is the sole producer of this key enabling excipient.
“To meet Captisol demand associated with Veklury, Hovione will soon be producing per month the quantity it usually produces in one year. This sudden spike in demand has required unique mobilization efforts across the Hovione network to secure additional raw material supply, execute major capital expenditure projects at our sites, 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 response.” said Jean-Luc Herbeaux, Chief Operating Officer.
“Ligand values its longstanding partnership with Hovione,” said Matt Foehr, President and Chief Operating Officer of Ligand. “Their excellent customer service, global commitment to quality and high pharmaceutical standards make them an ideal partner for Captisol®, a critical component for a number of life-saving medicines. We commend them for responsibly and efficiently partnering with Ligand to manage the scale up and expansion of their operations to contribute to global health during the pandemic.”
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Ligand’s Captisol technology is a patent protected, uniquely modified cyclodextrin, with a chemical structure that was rationally designed to enable the creation of new products by improving solubility, stability, bioavailability and dosing of active pharmaceutical ingredients (APIs). It uses a green manufacturing process that uses water as process solvent.
Gilead Sciences’ Veklury is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury for the treatment of SARS-CoV-2 infection, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies. The U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.