Last week, Eli Lilly promised to supply India with thousands of tablets of its arthritis drug baricitinib to aid a surge of hospitalized COVID-19 patients in the country and pledged to work with local companies to bring its supply up to speed. Now, it appears Lilly’s keeping its word.
The Indianapolis-based drugmaker has signed licensing agreements with three Indian generic drugmakers—Cipla, Lupin and Sun Pharma—to expand baricitinib’s availability in the country, the manufacturers said in separate announcements on Monday.
The royalty-free, non-exclusive voluntary licensing agreements mean Cipla, Lupin and Sun Pharma will now be charged with manufacturing and selling Lilly’s oral JAK inhibitor in India, which has faced a shortage of coronavirus treatments during its recent virus surge.
“Through this collaboration, we aim to join our forces with Lilly to accelerate access to baricitinib in India at a time when it is most needed,” Kirti Ganorkar, CEO-India business at Sun Pharma, said in a release.
India has set daily records for COVID-19 infections and deaths as the recent crisis has taxed its supply of hospital beds, oxygen and morgue space. The country is now recording more than 366,000 daily new infections and more than 3,700 daily deaths, Reuters reports, although experts have warned those tallies could be an undercount.
In the face of India’s deadly emergency, regulators authorized baricitinib for emergency use when combined with Gilead’s antiviral remdesivir at the beginning of May.
The combo therapy is intended for hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Last week, Lilly said it would supply India with an initial 400,000 tablets of baricitinib to help the country battle its raging outbreak while also hinting at the forthcoming licensing agreements. Lilly confirmed the voluntary licenses to Fierce Pharma in an email, adding that it's "also in discussions with several other Indian manufacturers for the potential grant of additional voluntary licenses."
The agreements will "ensure high quality manufacturing and accessibility of baricitinib during this pandemic" and help India by "improving the local treatment options available," Lilly spokesperson Kristen Porter Basu said in an email.
Additional supply of COVID-19 drugs has been a pressing need for India, which barred exports of remdesivir and the active pharmaceutical ingredients (API) used to make it in April in order to meet its own demand. As a result, local pandemic drugmakers have been rapidly scaling their capacities and making donations to help meet the country’s pressing needs.
For instance, Gilead pledged in late April to help local manufacturers boost production of remdesivir, marketed as Veklury, while also making a donation of at least 450,000 vials “to help ease the immediate need for treatment.”
Meanwhile, Merck announced that same day that it entered into non-exclusive voluntary licensing agreements with five generic manufacturers in India, including with Cipla and Sun Pharma, for its oral antiviral therapeutic candidate molnupiravir—developed alongside Ridgeback Biotherapeutics—that's currently in phase 3 trials for non-hospitalized patients.
Cipla also holds a partnership with Roche to produce and distribute its antibody cocktail, a combo of Casirivimab and Imdevimab, which received a fast-tracked emergency authorization in India last week.