Incepta gets go-ahead to produce Covid drug Molnupiravir

Leading local pharmaceutical company Incepta Pharmaceuticals Ltd has announced the receipt of a sublicence from the Medicine Patent Pool (MPP), on behalf of originator company MSD, to produce Covid-19 oral drug "molnupiravir".

Molnupiravir received approval from UK Medicines and Healthcare Products Regulatory Agency (MHRA) on November 4 last year and the emergency use authorisation from the United States Food and Drug Administration on December 23 same year, Incepta in a statement today.

It will be used for the treatment of mild-to-moderate coronavirus disease (Covid-19) in adults with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe Covid-19, including hospitalisation or death, and for whom alternative Covid-19 treatment options authorised by the FDA are not accessible or clinically appropriate.

US drugmaker MSD, a trade name of Merk & Co., Inc, Kenilworth, NJ, USA, and the MPP has given this sublicence to facilitate affordable global access for molnupiravir use in 105 low- and middle-income countries, including Bangladesh, following appropriate regulatory approvals.

The sublicensee Incepta Pharmaceuticals Ltd has Stringent Regulatory Authority (SRA) approved or World Health Organisation pre-qualified manufacturing facilities and experience as a major supplier to global and key low and middle-income procurers.

MPP is an UN-backed organisation that negotiates public-health-driven licences with patent holders and sublicences to generic manufacturers to encourage the sale of lower-cost generic versions of medicines.

Incepta Pharmaceuticals Ltd is a medicine manufacturing company founded in 1999 that provides high-quality medicines to the population in Bangladesh and across the globe. Incepta has a state-of-the-art GMP-compliant manufacturing facility and highly knowledgeable and skilled manpower to receive this kind of technology from the originator company and help to meet global supply through their huge capacity.

The company's track record as a leading generic manufacturer and its global reach to 80 countries will be leveraged, leading to an accelerated, timely, and successful entry and commercialisation of this Covid-19 oral medicine.

"We would like to thank MSD and MPP for choosing Incepta with their due selection process to grant this sub-license", said Abdul Muktadir, chairman and managing director of Incepta.

He also added, "Incepta can supply this product from two of its facilities, one of which is approved by UK authorities and another one is by German authorities," he said.

"We have initially allocated 90 million capsules capacity for this product but if required we can allocate much more."

"We are confident that with technical data from MSD, we will be able to register the product in all required countries as well as the WHO PQ programme. We believe we can become a global hub for low-cost production of this kind of products and can play a major role in the effort to end this pandemic."