Nortec Química receives Medicines Patent Poll license to produce API for nirmatrelvir for innovative oral treatment against Covid-19

Project agreed with The Medicines Patent Pool (MPP) aims to expand access to the drug in low- and middle-income countries

Nortec Química, a Brazilian Active Pharmaceutical Ingredient (API) manufacturer located in Rio de Janeiro, will produce the API nirmatrelvir under a license granted by the Medicines Patent Pool with authorization from Pfizer. Nirmatrelvir is part of an oral treatment for COVID-19 and has been submitted for register with ANVISA. The agreement between Pfizer and the MPP aims to expand production, distribution and access to approximately 53% of the world’s population across 95 countries.

As the leading API manufacturer in Latin America, Nortec Química will be able to fulfill the partnership’s goal of ensuring global supply chains, easing pressure on health systems and saving lives. The Pfizer COVID-19 oral treatment has shown to have a reduced risk of hospitalization or death from any cause by 89% within three days of symptom onset compared to placebo. It is administered as a dose of 300 mg of nirmatrelvir with 100 mg tablet of ritonavir, given twice daily for five days. The FDA’s emergency use authorization for the oral treatment is based on the clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial conducted by Pfizer Inc.

Marcelo Mansur, Nortec Química’s CEO, highlights that the inclusion of Nortec in the manufacturing license of Nirmatrelvir API demonstrates the importance of the Brazilian industry in expanding a global manufacturing network. “Nortec Química has built world-class quality, technological, and manufacturing capabilities throughout its 40-year history exclusively dedicated to the production of APIs in Brazil. Participating in this project with MPP is a validation of that history and an opportunity to contribute to global access to such an essential product. We look forward to dedicating all our resources and expertise to ensure the success of this cooperation.”

For Charles Gore, Executive Director of the Medicines Patent Pool the partnership will play a critical role in saving lives. “MPP delighted to be working with Nortec Quimica towards rapidly bringing safe and efficacious Covid-19 treatments to those in need in low- and middle-income countries.”

With this agreement, the Active Pharmaceutical Ingredient nirmatrelvir can be fully manufactured in Brazil by Nortec Química, ensuring safety and adherence to treatment for countries including: South Africa, Tanzania, Venezuela, Bolivia, Ethiopia, Haiti, Honduras, among others.

About Nortec Química

Nortec Química is the largest manufacturer of Active Pharmaceutical Ingredients (APIs) in Latin America, investing in Technology, Research and Development and Innovation in its processes. The Company is the only producer of Benznidazol in the world, API used in the treatment of Chagas Disease and is the largest producer of Antiretrovirals in the West. The relevance of Nortec Química in the world scenario remains with the increase of the productive capacity and the performance in R&D with the project of installation of the First Plant for High Power Drugs, contributing with technological solutions for the improvement of well-being, life and health of people. Currently, an entire Nortec Química plant is dedicated to the production of Midazolam, the sedative used in the Covid-19 intubation kit. The company was founded in the 1980s in Xerém, Duque de Caxias, in the Baixada Fluminense.