PR84025

Hetero Enters Into a Licensing Agreement With Gilead Sciences, Inc. for the Manufacturing and Distribution of "Remdesivir" in 127 Countries, Including India, for COVID-19

HYDERABAD, India, May 14, 2020 /PRNewswire=KYODO JBN/ --

Hetero, one of India's leading generic pharmaceutical companies and the world's

largest producer of anti-retroviral drugs, announced today that it has entered

into a licensing agreement with Gilead Sciences, Inc. for the manufacturing and

distribution of "Remdesivir" for the treatment of Covid-19. Under this

licensing deal, Hetero will be supplying Remdesivir in 127 countries, including

India, subject to regulatory approvals in respective countries.

Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented:

"Hetero is pleased to partner with Gilead to enable access for this important

drug to India and other developing countries at this crucial time. This

agreement also illustrates the significance of global collaboration and the

need for coming together to fight the health crises impacting humanity. Hetero

has developed this product in India and has already been working with the

government, ICMR, and DCGI for necessary studies and approvals to bring this

product to treat COVID-19 patients in India."

Remdesivir will be manufactured in our formulation facility in Hyderabad,

India, which has been approved by stringent global regulatory authorities such

as USFDA and EU, among others. Hetero has developed the fully vertically

integrated supply chain for this product complementing the "Make in India"

campaign as defined by our Hon'ble Prime Minister.

Important Information about Remdesivir

U.S. Food and Drug Administration (FDA) has granted emergency use authorization

(EUA) for the investigational antiviral Remdesivir to treat COVID-19.

Remdesivir is authorized for the treatment of hospitalized patients with severe

COVID-19 disease. The optimal duration of treatment is still being studied in

ongoing clinical trials. Under the EUA, both 5-day and 10-day treatment

durations are suggested, based on the severity of disease. The authorization is

temporary and does not take the place of the formal new drug application

submission, review and approval process. The EUA allows for the distribution

and emergency use of Remdesivir only for the treatment of COVID-19; Remdesivir

remains an investigational drug and is not approved anywhere globally including

US and India.

About Hetero

Hetero is one of India's leading generic pharmaceutical companies and the

world's largest producer of anti-retroviral drugs. With 25 years of expertise

in the pharmaceutical industry, Hetero's strategic business areas spread across

APIs, generics, biosimilars, custom pharmaceutical services and branded

generics.

Hetero has 36 state-of-the-art manufacturing facilities, 300 plus products in

its portfolio and has a strong global presence in over 126 countries. For more

information on Hetero, please visit www.heteroworld.com.

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Media Contact:

Jeyasingh Balakrishnan

Head – Corporate Communications

Hetero Labs Limited

Mobile: (+91) 9989626541, (+91) 9833836185

Source: Hetero