Home Beximco Pharma to Launch World’s First Molnupiravir Generic Emorivir Following Rapid Regulatory Approval in Bangladesh

Beximco Pharma to Launch World’s First Molnupiravir Generic Emorivir Following Rapid Regulatory Approval in Bangladesh

Nov 12, 2021 10:54 CST Updated 10:54
Beximco Pharmaceuticals

Generic Drug Manufacturer

MSD

Pharmaceutical R&D and Manufacturer

(Shanghai, Editor: Zhengzhi Shi, Cailian Press) - On Tuesday local time, Beximco Pharmaceuticals Ltd., located in Bangladesh, announced that it would begin selling a generic version of MSD's COVID-19 oral drug Molnupiravir. This is the world's first generic version of the drug to be launched on the market.

Beximco Pharmaceuticals has named this generic drug Emorivir. Having received approval from the local drug regulatory authority earlier, this affordable generic COVID-19 drug is expected to hit the market soon, while export will depend on specific regulatory reviews. Beximco anticipates that due to the relatively low infection rate in Bangladesh, this drug will not significantly boost revenue. The company has not disclosed the specific pricing.

Md Ayub Hossain, head of Bangladesh's drug regulatory authority, stated that in addition to issuing an Emergency Use Authorization (EUA) to Beximco on Monday, many pharmaceutical companies in the country are also in the application process. In principle, the relevant pharmaceutical companies need to first produce generic drugs, submit them to the regulatory authorities, and after review, they can begin large-scale production.

As a nucleic acid antiviral drug, molnupiravir works by introducing errors into the virus's genetic code. According to phase III data released in early October, 7.3% of patients who took the drug required hospitalization and none died, compared with 14.1% in the control group, including eight deaths. This also implies that the drug can reduce the risk of hospitalization or death by 50%. The drug received approval from UK regulators on November 4, while the EMA and the US FDA are still reviewing the trial data.

As the world's first oral COVID-19 drug, MSD's pricing of $700 per treatment course has also raised concerns about the affordability for low-income countries. In response, MSD has granted voluntary licensing agreements to at least eight Indian pharmaceutical companies. Vice President Krishnamoorthy also expressed concerns that production in just one country may not meet the needs of low- and middle-income nations.

On October 27, MSD reached a licensing agreement with the Medicines Patent Pool (MPP), which is backed by the United Nations. This agreement allows pharmaceutical factories in 105 low- and middle-income countries to obtain the formula and start production, mainly in Asian and African countries. Bangladesh is also one of these 105 countries.