Hetero’s ‘NIRMACOM’ is world’s first generic version of COVID-19 oral drug ‘PAXLOVID’ to receive WHO Prequalification

- Hetero’s ‘NIRMACOM’ (Nirmatrelvir), a generic version of Pfizer’s COVID-19 oral antiviral drug ‘PAXLOVID’ is co-packaged with ritonavir tablets

- With the launch of NIRMACOM, Hetero aims to expand access of the ground-breaking antiviral in 95 LMICs including India

Hyderabad, December 26, 2022 Hetero, India’s leading pharmaceutical company with the widest global reach, today announced the receipt of World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its generic version of COVID-19 oral antiviral treatment candidate nirmatrelvir. This is the first prequalification for a generic version of Pfizer’s COVID-19 oral antiviral drug ‘PAXLOVID’, which the WHO called, the best therapeutic choice for high-risk patients to date.

WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate COVID-19 patients at highest risk of hospital admission, such as unvaccinated, aged, or immunosuppressed patients.

The combi pack, launched by Hetero as NIRMACOM, will contain nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet). It is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. NIRMACOM will be manufactured at Hetero’s facilities in India.

Dr. Vamsi Krishna Bandi, Managing Director, Hetero Group of Companies, said: “WHO Prequalification for NIRMACOM is a significant milestone in the fight against COVID-19 as it allows us to expand access to this important innovative antiretroviral drug to people in need. We are committed to making NIRMACOM available faster at affordable prices across 95 LMICs including India.”

Hetero entered into a non-exclusive voluntary licensing agreement with Medicines Patent Pool (MPP) for manufacturing and sale of a generic version of Pfizer’s COVID-19 oral antiviral treatment candidate nirmatrelvir, which is co-packaged with ritonavir (nirmatrelvir; ritonavir), in LMICs.

Charles Gore, Executive Director of MPP said: “We are delighted to see the first generic version of nirmatrelvir under MPP license with Pfizer, receive quality assurance approval from WHO. This is an impressive achievement from Hetero as we announced the sublicence agreements just nine months ago. With cases of COVID-19 again on the rise we need to make treatments readily available in LMICs so no one is left behind.”

Hetero has already received Emergency Use Authorization (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market NIRMACOM.

Statement: WHO recommends highly successful COVID-19 therapy and calls for wide geographical distribution and transparency from originator

About PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)

PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

About Hetero

Hetero is a globally renowned vertically integrated pharmaceutical organization engaged in research and development, manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas. Backed by 30 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Global Generics, Biosimilars and Custom Pharmaceutical Services. The company is among the largest producers of Active Pharmaceutical Ingredients (APIs) in the world. For more information on Hetero, please visit www.hetero.com.