The companies have won the nod after entering into a sublicense pact with Medicines Patent Pool (MPP), a UN-based public health organization working to increase access to life-saving medicines for low- and middle-income countries.
Leading drug makers Cadila Pharmaceuticals, Aurobindo Pharma and Torrent Pharmaceuticals said Thursday they have received a license to manufacture and sell a generic version of Pfizer’s oral antiviral COVID-19 medication PAXLOVID in 95 countries, including India.
The companies have won the nod after entering into a sublicense pact with Medicines Patent Pool (MPP), a UN-based public health organization working to increase access to life-saving medicines for low- and middle-income countries.
Previously, MPP had signed a voluntary licensing agreement with Pfizer to sublicense this COVID-19 treatment product to qualified generic drug manufacturers.
“We are excited to partner with MPP to create a generic version of the innovative drug PAXLOVID for the global community and help reduce the health burden caused by the pandemic.
“We reiterate our commitment to making affordable innovations available to the last man in society,” Cadila Pharmaceuticals CMD Rajiv Modi said in a statement.
Cadila said it will target Indian and export markets as many countries with a high COVID-19 burden do not have access to effective therapy.
Pfizer markets its oral COVID-19 treatment under the name PAXLOVID, which is authorized by the US Food and Drug Administration (FDA) for emergency authorization (EUA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of COVID-19 in patients at high risk of developing serious disease.
The USFDA was the first regulatory agency to approve the use of PAXLOVID, nirmatrelvir tablets, and ritonavir tablets, packaged together for oral use, for the treatment of mild to moderate high-risk COVID-19 adults and pediatric patients over the age of 12. years with a weight of at least 40 kg.
“Aurobindo has already developed and commercialized ritonavir, which is used as a booster along with nirmatrelvir.
“We are excited to be working on this molecule and will soon make it commercially available at an affordable price to these markets after a rigorous process of registration and approval in several countries, including DCGI in India,” Vice Chairman and Managing Director K Nithyananda Reddy of Aurobindo.
Reddy added that this combination along with Molnaflu (molnupiravir) for the treatment of COVID-19 will be a very valuable addition to our portfolio.
For nirmatrelvir and ritonavir molecules, like other antivirals, the company benefits from backward integration with in-house API manufacturing, giving it greater supply chain control and cost savings, the company said.
Torrent Pharmaceuticals noted that it has signed a non-exclusive, non-transferable, non-sublicensable license agreement to use the patents and know-how related to the compound niramatrelvir with MPP to manufacture and commercialize the generic version of PAXLOVID. This is being 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 delighted to enter into this agreement with MPP and are part of our ongoing commitment to make COVID-19 treatments as accessible as possible to patients.” The company will launch the product after obtaining necessary regulatory approval.
This post Cadila, Aurobindo, Torrent Get Licensed to Make Generic Version of Pfizer’s Oral COVID Medication
was original published at “https://www.financialexpress.com/lifestyle/health/cadila-aurobindo-torrent-get-licence-to-make-generic-version-of-pfizers-oral-covid-medication/2464449/”
