Landmark Development, Dr. Zafar Mirza Announces Start of Local Manufacture of Breakthrough Drug to treat COVID 19

Landmark Development, Dr. Zafar Mirza Announces Start of Local Manufacture of Breakthrough Drug to treat COVID 19

Islamabad : 15 May, 2020

Pakistan to start Manufacture of Breakthrough Corona drug under license from US firm.
Major Success on Public Health and Diplomatic Front-Pakistan firm licensed to Manufacture COVID 19 Drug.
Pakistan Scores Major Victory on public health and diplomatic front as US firm Gilead has licensed a Pakistani firm to manufacture breakthrough drug to treat COVID 19
This was shared by Dr. Zafar Mirza SAPM on Health while addressing a Press briefing here today.
The drug Remdesivir will be registered on fast track basis by DRAP to fulfill legal requirements shared Dr. Zafar Mirza
In a press conference at the National Command and Operation Centre (NCOC), the Special Assistant to the Prime Minister on National Health Services, Dr. Zafar Mirza, announced that the breakthrough COVID-19 treatment Remdesivir, developed by Gilead Sciences Inc., USA will soon be manufactured locally in Pakistan under license from Gilead.

Remdesivir was granted emergency use authorization (EUA) by the USFDA on May 1 and approved by the Japanese authorities on May 8. On May 12, Pakistani manufacturer BF Biosciences Limited (a subsidiary of Ferozsons Laboratories Limited), successfully concluded its voluntary licensing agreement with Gilead Sciences, Inc. for the manufacture and sale of Remdesivir under Gilead’s Global Patient Solutions Program to supply the product to 127 countries in the developing world affected by the pandemic. Gilead has signed non-exclusive voluntary license agreements with five South Asian manufacturers including BF Biosciences Limited from Pakistan. Under the agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to ensure product quality and to scale up production quickly.

Dr. Mirza pointed out that this is for the first time that a manufacturer from Pakistan has been included in a global supply solution of this nature. The development represents an important step forward for Pakistan on the health, economic and diplomacy fronts. It helps provide our citizens and frontline healthcare workers access to the latest treatment for the pandemic in a fast-track manner. It also represents an important export opportunity for the country’s pharmaceutical sector at a critically important period. Export of the drug to the developing world at this time of need will also position Pakistan to play its rightful role on the global stage of public health.

Production can commence as early as 8 weeks after the necessary regulatory approvals are obtained, and the manufacturer is confident that it will produce sufficient quantities over time to serve the needs of the patients in Pakistan and access countries abroad. Dr. Mirza stated that the Government appreciates this important licensing step by Gilead Sciences, and pledged to support the urgent availability of Remdesivir so that it is made available to patients on a timely basis

Mr. Abdul Razak Dawood Advisor to Pm on commerce stated that the local manufacture of Remdisivir by BF Biosciences Limited represents an important export opportunity for the country’s pharmaceutical sector at a critical period. Export of the drug to the developing world at this time of need will also position Pakistan to play its rightful role on the global stage of public health.

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