The companies have received the nod after inking a sub-licensing pact with Medicines Patent Pool (MPP), a UN-based public health organisation working to increase access to life-saving medicines for low- and middle-income countries.
Leading drug makers Cadila Pharmaceuticals, Aurobindo Pharma and Torrent Pharmaceuticals on Thursday said they have received a licence to manufacture a generic version of Pfizer’s oral antiviral COVID-19 medication PAXLOVID and sell it in 95 countries, including India.
The companies have received the nod after inking a sub-licensing pact with Medicines Patent Pool (MPP), a UN-based public health organisation working to increase access to life-saving medicines for low- and middle-income countries.
Earlier, MPP had signed voluntary licensing agreement with Pfizer for sub-licensing this COVID-19 treatment product to qualified generic drugmakers.
“We are pleased to partner with MPP to make a generic version of the innovative medicine PAXLOVID for the global community and contribute towards reducing the health burden due to the pandemic.
“We reiterate our commitment to make affordable innovations available to the last man in society,” Cadila Pharmaceuticals CMD Rajiv Modi said in a statement.
Cadila said it will cater to Indian and export markets since many countries with high COVID-19 burden lack access to effective therapy.
Pfizer markets its oral COVID-19 treatment under the name PAXLOVID, which is authorised by US Food and Drug Administration (FDA) for emergency use authorisation (EUA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of COVID-19 in patients at high-risk of progressing to serious illness.
The USFDA was the first regulatory agency to authorise the use of PAXLOVID, nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use to treat high-risk mild-to-moderate COVID-19 adults and paediatric patients above 12 years of age weighing at least 40 kg.
“Aurobindo has already developed and commercialized ritonavir which is used as a booster along with nirmatrelvir.
“We are excited to work on this molecule and will soon make it available commercially at an affordable price for these markets after due process of registration and approval in various countries including DCGI in India,” Aurobindo Vice-Chairman and Managing Director K Nithyananda Reddy.
Reddy added that this combination will be a very valuable addition to our portfolio along with Molnaflu (molnupiravir) for the treatment of COVID-19.
For nirmatrelvir and ritonavir molecules, like other antivirals, the company enjoys backward integration with in-house API manufacturing which equips it with stronger control on supply chain and cost efficiencies, the company stated.
Torrent Pharmaceuticals noted that it has signed a non-exclusive, non-transferable, non-sub licensable, licence agreement to use the patents and know-how in relation to the compound nirmatrelvir with MPP for manufacture and commercialisation of the generic version of PAXLOVID. This is to be co-packaged and co-administered with ritonavir in 95 low- and middle-income countries, including India, for the treatment and/or prevention of COVID-19 caused by SARSCoV-2.
Commenting on the arrangement, Aman Mehta (Executive Director) said: “We are pleased to enter into this agreement with MPP and is part of our continued endeavour to make COVID-19 treatments as accessible as possible to patients.” The company will launch the product after obtaining necessary approval from regulatory agencies.
