Roche has entered into a voluntary licensing agreement to provide the popular anti-influenza virus drug Xofluza (baloxavir marboxil) to generic drug manufacturers in 129 developing countries.
MPP said in a May 18 release that the agreement with the Pharmaceutical Patent Pool will enable generic supply of baloxavir in 129 low- and middle-income countries and “support both seasonal influenza and broader pandemic preparedness and response efforts.”
The agreement creates “additional supply channels for equitable access, which is particularly important during the pandemic when demand is at its highest,” UN aid agency MPP said in a statement.
As part of the agreement with Roche, MPP is seeking applications from qualified generic manufacturers with the necessary capabilities to support the development and supply of generic Xofluza.
Once a generic manufacturer is identified, Roche will provide access to data packages, bioequivalence studies and reference Xofluza products for any necessary regulatory exemptions. Each sublicensee remains responsible for independently developing and manufacturing the generic version.
Pandemic preparedness is once again in the spotlight as hantavirus and Ebola outbreaks continue.
The deal with Xofluza is about improving access to influenza treatment in low- and middle-income countries, while also reflecting a shared commitment to “pandemic prevention, preparedness, and response (…) to ensure we have the tools and manufacturing capacity needed before the next health emergency,” Charles Gore, MPP’s executive director, said in a statement.
Roche CEO Thomas Schinecker added that the license is “an important step towards strengthening global health resilience, particularly in LMICs.”
Roche has first-hand experience of how the health crisis affects demand for Xofluza. A sharp rise in influenza cases in China in early 2025 raised concerns about shortages as antiviral drugs became difficult to obtain. In response, Roche shifted its supply of Xofluza to the country to ensure stability.
A Roche spokesperson told Fierce that the Swiss drugmaker is not among the 129 countries included in Roche’s latest agreement with MPP because it “already has a strong presence in the country, including dedicated manufacturing and distribution capabilities for Xofluza.”
“The selection of countries for voluntary licensing with MPP was a deliberate and strategic decision to prioritize areas where access challenges are greatest and where people are most vulnerable in the event of a potential outbreak,” the spokesperson added.
The unpredictability of each flu season has led to significant fluctuations in sales of Roche’s Xofluza. Xofluza’s sales in the first quarter of 2026 were CHF 19 million, 83% below analysts’ expectations and the biggest difference in the company’s three-month earnings. Roche cited a decline in sales of the drug compared to the previous year in China due to the weakening of the influenza pandemic.
The successor to Roche’s Tamiflu, Xofluza was first approved in the United States in 2018 to treat acute uncomplicated influenza, and was later approved to prevent influenza after contact with an infected person.
Through a “most-favored-nation” drug pricing agreement recently reached with the Trump administration, Roche is offering Xofluza on its direct-to-consumer platform TrumpRx for $50 instead of the usual $168.
This is not the first time Roche has partnered with MPP. MPP pools intellectual property to facilitate the supply of generics to underserved areas. In 2013, Roche signed a patent on Valcyte, a drug used to prevent and control cytomegalovirus infections, allowing MMP’s partners to make the drug available at low cost in developing countries.
Antivirals are a large component of MPP’s licensing partnerships with industry. The UnityAid-funded organization has agreements with GSK and Gilead Sciences for HIV drugs, and also signed agreements with Pfizer and Merck & Company for oral COVID-19 drugs during the pandemic.
