Zydus signs a non-exclusive licensing agreement with Gilead Sciences Inc., to manufacture and market Remdesivir
? Remdesivir, the investigational drug from Gilead Sciences Inc., has been issued an
Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) to treat
patients suffering from severe symptoms of Novel Coronavirus (COVID 19)
? Under the agreement, the license is royalty free until another pharmaceutical product or
vaccine is approved for the treatment or prevention of Covid 19 by the USFDA or EMA or the
WHO announcing the end of the public health emergency.
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Ahmedabad, June 12, 2020
Zydus Cadila, an innovation-driven, global healthcare company today announced that it has
signed a non-exclusive licensing agreement with Gilead Sciences Inc., for the manufacturing
and distribution of Remdesivir, the investigational drug, which has been issued an Emergency
Use Authorization by the U.S. Food and Drug Administration (FDA) to treat patients
suffering from severe symptoms of Novel Coronavirus. Zydus has been supporting the fight
against COVID 19 with therapeutics, vaccines and diagnostics.
Speaking on the development, Chairman of Zydus, Mr. Pankaj Patel said, ?We are happy to
collaborate with Gilead Sciences and increase the access to this life saving drug for patients
suffering from COVID 19. Over the last decade, we have been partnering with Gilead
Sciences to address various public healthcare challenges and improve global access to
affordable need-based therapies. At this critical juncture, we join hands once again to ensure
that no efforts are spared in the fight against this pandemic.?
As part of the non-exclusive agreement, Zydus will receive the manufacturing know-how
from Gilead Sciences Inc., to manufacture the API for Remdesivir and the finished product
and market it in 127 countries, including India. Under the agreement, the license is royalty
free until another pharmaceutical product or vaccine is approved for the treatment or
prevention of COVID 19 by the USFDA or EMA or the WHO announcing the end of the
public health emergency. Zydus will leverage its ability to scale up production to reach
patients across India and across the 127 countries in Gilead?s Global Patient Solution region.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity
both in vitro and in vivo in animal models against multiple emerging viral pathogens,
including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has
demonstrated that Remdesivir is active against the virus that causes COVID-19. The safety
and efficacy of remdesivir to treat COVID-19 are being evaluated in multiple ongoing Phase
3 clinical trials.
Remdesivir must be administered intravenously. Under this EUA, the 10-day dosing duration
is suggested for patients requiring invasive mechanical ventilation and/or extracorporeal
membrane oxygenation (ECMO), and the 5-day dosing duration is suggested for patients not
requiring invasive mechanical ventilation and/or ECMO. If a patient on the 5-day dosing
duration does not demonstrate clinical improvement after five days, treatment may be
extended for up to five additional days (10 days total).
About Zydus Cadila
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops,
manufactures and markets a broad range of healthcare therapies. The group employs nearly
25000 people worldwide and is dedicated to creating healthier communities globally