May 18 (Reuters) - Roche and the Medicines
Patent Pool have signed a licensing agreement to expand access
to the Swiss drugmaker's flu drug, Xofluza, in low- and
middle-income countries, the organizations said on Monday,
aiming to boost supply during seasonal outbreaks and potential
pandemics.
The deal will allow generic drugmakers to develop,
manufacture and supply the antiviral pill across 129 such
countries, creating additional supply channels in regions where
access to flu medicines remains limited.
The Medicines Patent Pool, a United Nations-backed public
health group, said it would invite expressions of interest from
manufacturers to produce the drug under license.
Roche's Xofluza is used to treat flu in patients who have
had symptoms for no more than two days.
The treatment, which is recommended by the World Health
Organization and approved by regulators in the United States and
Europe, has shown effectiveness against some flu strains
resistant to older antiviral classes, making it an important
tool in managing outbreaks, the groups said.
"This public health-oriented agreement is an important step
towards further improving access to influenza treatment in
LMICs," MPP Executive Director Charles Gore said, adding it
aimed to ensure tools and manufacturing capacity are in place
before the next health emergency.
Under the agreement, Roche will provide licenses with access
to data packages, reference products for bioequivalence studies
and certain regulatory support to help accelerate the
development of the drug's generic versions, while manufacturers
will independently handle their own approval processes.
In October, Roche launched direct-to-consumer U.S. sales of
Xofluza at a discounted cash price of $50, following similar
moves by rivals as they scramble to address pressure from the
Trump administration to lower prescription drug prices paid by
Americans.