By partnering with a UN-backed body, Roche has enabled companies to make the medicine for supply in 129 countries.
Roche has signed off on generic production of its antiviral influenza treatment baloxavir marboxil, inking a voluntary license agreement to expand access to the drug.
The Swiss company’s agreement with the Medicines Patent Pool (MPP), a United Nations–backed public health body, will allow generic manufacturers to develop, produce and supply baloxavir in 129 low- and middle-income countries. MPP has asked companies that want to supply the product in the countries to send details of their capacity, capabilities and track record for manufacturing quality-assured medicines.
Roche’s Genentech charges U.S. cash-pay patients $50 for the antiviral, which it sells as Xofluza, under the terms of a direct-to-patient initiative introduced last year. The cash-pay rate is 70% lower than the list price, Genentech said.
Allowing generic companies to manufacture and supply the drug could support lower prices outside the U.S. and other advanced economies. The model adopted by MPP, which struck its first deal in 2011, has cut the annual cost of an HIV drug to $70 in Africa, compared to $10,000 in Europe, Marisol Touraine, chair of the executive board at MPP-backer Unitaid, said in a statement.
Most of MPP’s agreements cover HIV, but the organization also has licenses for treatments of conditions including hepatitis C, tuberculosis and cancer. Baloxavir is a long-standing target for MPP, with the body including the single-dose oral antiviral treatment on the priority licensing list in its 2024 annual report.
In 2023, MPP said baloxavir is available in a small number of low- and middle-income countries at prices that are generally higher than for oseltamivir, another antiviral that Roche sells as Tamiflu. Clinical trials have shown that the time to the alleviation of influenza signs and symptoms is similar for baloxavir and oseltamivir. Baloxavir is administered once, compared to twice daily for five days on oseltamivir.
Manufacturing informed MPP’s decision to prioritize securing a license for baloxavir. Production involves a standard manufacturing process for tablets, MPP said, and there are no challenges related to excipients or final packaging. Roche will give generic manufacturers access to a foundational data package, reference products for bioequivalence studies and necessary regulatory waivers.
Securing rights to baloxavir will support seasonal flu and broader pandemic preparedness and response efforts, MPP said. The deal contains specific provisions for pandemics, with Roche and MPP agreeing to collaborate to remove access barriers such as “supply constraints, territory restrictions and royalties” in the event of a global flu outbreak.
