35 Pharmaceutical Companies Allow Free Production Of Pfizer's New Crown Oral Drug

In the latest news, the Geneva Medicines Patent Pool (MPP) announced that it has signed agreements with 35 pharmaceutical companies to allow them to produce nirmatrelvir, one of the ingredients of Pfizer's new oral drug Paxlovid. Including 5 Chinese companies, namely Shanghai Desano, Huahai Pharmaceutical, Puluo Pharmaceutical, Fosun Pharmaceutical, and Jiuzhou Pharmaceutical. Jiuzhou Pharmaceutical only produce APIs, while the other four can produce APIs and preparations at the same time.

The non-exclusive sublicense agreement allows generic companies to manufacture the active ingredient nirmatrelvir API and/or preparations for the novel coronavirus oral medicine. Sublicensed companies have successfully demonstrated their ability to meet MPP requirements for manufacturing capacity, regulatory compliance, and meeting international standards for quality-assured medicines.

Among the 35 companies, 6 will focus on the production of APIs, 9 will be responsible for the production of preparations, and the remaining 20 companies will produce both APIs and preparations. They are located in 12 countries: Bangladesh, Brazil, China, Jordan, India, Israel, Mexico, Pakistan, South Korea, Vietnam, Serbia, Dominican Republic. Another Ukrainian company was unable to sign the agreement due to the conflict, but the license is still valid.

In November 2021, Pfizer announced that it had reached an agreement with the United Nations-backed MPP organization to allow other generic drugmakers to produce its Covid-19 oral drug Paxlovid. The agreement will enable MPP to facilitate additional production and distribution of investigational antiviral drugs by sublicensing qualified generic manufacturers, pending regulatory authorization or approval, to enable greater access to the global population.

Under the terms of the agreement, globally licensed and qualified generic companies will be able to provide Paxlovid's combination therapy to 95 countries, covering approximately 53% of the global population, including all low- and lower-middle-income countries in sub-Saharan Africa and Some upper-middle-income countries, and countries that have transitioned from lower-middle-income status to upper-middle-income status in the past five years.

While COVID-19 is still classified by the World Health Organization as a Public Health Emergency of International Concern, Pfizer will not charge royalties for sales in low-income countries and will further waive the license fees in all countries covered by the agreement. Sales authorization royalties. Pfizer will charge a 5% royalty for the public sector in low- and upper-middle-income countries and a 10% royalty for the private sector.