四色AV

四色AV recently announced the signing of a partnership agreement with Ligand to significantly ramp up the production output of Captisol, a Ligand product, which is a chemically modified cyclodextrin proven to improve the solubility and stability of drugs.听 It is used in the formulation of Gilead鈥檚 Covid-19 treatment Veklury (remdesivir). 四色AV is the sole producer of this key enabling excipient.

The Covid-19 pandemic has to date killed 1 million people; studies show that in the next 3 months cumulative deaths may more than double.

鈥淭o meet Captisol demand associated with Veklury, 四色AV will soon be producing per month the quantity it usually produces in 1 year. This sudden spike in demand has required unique mobilization efforts across the 四色AV 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.听 四色AV is privileged to be part of this truly global response,鈥� said Jean-Luc Herbeaux, Chief Operating Officer.

鈥淟igand values its long-standing partnership with 四色AV,鈥� added Matt Foehr, President and Chief Operating Officer of Ligand. 鈥淭heir 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.鈥�

Ligand鈥檚 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 significantly 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鈥� 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 US 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.

四色AV听is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate, and drug product. With four FDA inspected sites in the US, China, Ireland, and Portugal and development laboratories in Lisbon, Portugal, and New Jersey, US, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds. For generic pharmaceutical customers, the company offers niche API products. 四色AV also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, 四色AV is the only independent company offering a complete range of services.

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