Gilead licenses remdesiver production to India and Pakistan

Linda J. Dodson

NEW DELHI — U.S.-based Gilead Sciences has tied up with India’s Cipla and Jubilant Life Sciences, Pakistan’s Ferozsons Laboratories and two other generic pharmaceutical makers to ramp up the supply of remdesivir, its closely watched investigational coronavirus drug.

The non-exclusive voluntary licensing agreements allow the partner companies to produce remdesivir for distribution in 127 countries, Gilead said in a statement. “The countries consist of nearly all low-income and lower-middle-income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access,” the statement says.

These nations include Afghanistan, Bangladesh, Cambodia, Egypt, Fiji, India, Indonesia, Myanmar, Nepal, Pakistan, the Philippines, Thailand, Ukraine, Vietnam and Zimbabwe.

Gilead has also licensed production of the drug to India-based Hetero Labs as well as to Mylan, which is headquartered in the U.S but has about half of its workforce of 35,000 and 21 manufacturing sites in India.

The announcement comes nearly two weeks after the U.S. Food and Drug Administration granted emergency use authorization for remdesivir to treat COVID-19. Trial results announced in late April by the U.S. National Institutes of Health say the median recovery time for patients treated with remdesivir was 11 days, compared to 15 days for those who received a placebo.

As part of the licensing agreements, the companies have been granted the right to receive a technology transfer of the remdesivir manufacturing process, to enable them to scale up production more quickly, the U.S pharmaceutical company’s statement says.

“The licensees also set their own prices for the generic product they produce,” the statement says. “The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.”

Commenting on the partnership with Gilead, Shyam S. Bhartia, chairman of Jubilant Life Sciences, and Hari S. Bhartia, its co-chairman and managing director, jointly said in a statement that based on initial data remdesivir shows promise as a potential therapy for COVID-19.

“We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals,” their statement says. “We also plan to produce the drug’s Active Pharmaceutical Ingredient in-house helping its cost-effectiveness and consistent availability.”

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