Summary :
- The drug received conditional marketing authorisation in the UK from the MHRA in November
- Beximco Pharma has announced that the United Nations-backed Medicines Patent Pool (MPP) has expanded its network of partnered manufacturers to include Beximco Pharma – a prolific global producer of pharmaceuticals.
Under the terms of the agreement, the company will be granted a sub-licence by the MPP to produce molnupiravir. The therapy is an oral antiviral medication that inhibits the replication of certain RNA viruses and, pivotally, it is also used to treat COVID-19 in those infected by SARS-CoV-2.
The drug received conditional marketing authorisation in the UK from Medicines and Healthcare products Regulatory Agency (MHRA) in November 2021 and received Emergency Use Authorisation in the US from the Food and Drug Administration (FDA) the following month.
Beximco Pharma will manufacture molnupiravir in Bangladesh and expects to start domestic distribution and export by the end of 2022, following manufacturing regulator approvals and successful technology transfer.
Until then, the company will continue to sell its own generic version of molnupiravir (Emorivir) as announced in November, under the World Trade Organization’s Least Developed Country (LDC) waiver.
Meanwhile, the company – which is a leading manufacturer and exporter of medicines – will continue to deliver its broad portfolio of tablets, capsules, semi-solids and intravenous fluids.
Managing director of Beximco Pharma, Nazmul Hassan, commented: “Since the start of the pandemic, we have remained committed to assessing opportunities to increase the access and affordability of COVID-19 treatments for patients.
“As such, we are delighted to have been granted a sub-licence to produce molupiravir by the United Nations-backed Medicines Patent Pool. To partner with such a prestigious organisation is testament to the quality of our manufacturing capabilities and is also aligned to our corporate mission by enabling broad access to this oral treatment in many low- and middle-income countries.”
Molnupiravir is an oral antiviral to treat symptomatic Covid-19, which received conditional marketing authorization in the UK from the UK Medicines and Healthcare Regulatory Agency on November 4, 2021 and received Emergency Use Authorization in the US from the US Food and Drug Administration on December 23, 2021.
The sub-license agreement is a result of the voluntary licensing agreement signed by the MPP and MSD in October 2021 to facilitate affordable global access for molnupiravir.
Under this agreement, MPP may sub-license the production of the drug to global generic drug manufacturers to ensure a steady supply in different regions of the world.
Beximco Pharma will manufacture molnupiravir in Bangladesh and expects to start domestic distribution and export from the end of 2022, following successful technology transfer and manufacturing regulatory approvals, under license from MPP.
The company will continue to sell its own generic version of molnupiravir (Emorivir), as announced on November 9, 2021, under the World Trade Organization’s Least Developed Country (LDC) waiver in the meantime.
Managing Director of Beximco Pharma Nazmul Hassan said: “Since the start of the pandemic, we have remained committed to improving access to breakthrough Covid-19 treatments for the patients. We are delighted to have been granted a sub-license to produce molnupiravir by the Medicines Patent Pool.”
“To partner with such a prestigious organisation is a testament to the quality of our manufacturing capabilities and is also aligned to our corporate mission by enabling broad access to this oral treatment in many low and middle-income countries,” he added.
About Beximo Pharma
Beximco Pharmaceuticals Ltd also known as Beximco Pharma, is a pharmaceutical company in Bangladesh. It is part of the Beximco Group of Companies.
Beximco Pharma was founded in 1976 and started operations in 1980, manufacturing products under the licenses of Bayer AG of Germany and Upjohn Inc. of United States. Today Beximco Pharma manufactures and markets its own branded generics for several diseases including AIDS, cancer, asthma, hypertension, and diabetes for both national and international markets. It was the first drug company from Bangladesh to sell its products in the US.
In May 2020, the company introduced the world’s first generic remdesivir for COVID-19 treatment. Beximco Pharma became the first company to obtain production and marketing authorization for Molnupiravir, the first and only specific oral anti covid drug in Bangladesh along with Eskayef Pharmaceuticals. Beximco Pharma’s branded generic version of molnupiravir is being marketed as Emorivir.
