FILE PHOTO: Gilead Sciences headquarters signal is seen in Foster Metropolis, California on April 30, 2020. – Gilead stated Wednesday, October 2, 2024, it had signed licensing offers with six generic drugmakers to supply and promote its HIV prevention medication in lower-income nations. (Photograph by Josh Edelson / Agence France-Presse)
US pharmaceutical large Gilead stated Wednesday it had signed licensing offers with six generic drugmakers to supply and promote its HIV prevention medication in lower-income nations.
WASHINGTON, United States — US pharmaceutical large Gilead stated Wednesday it had signed licensing offers with six generic drugmakers to supply and promote its HIV prevention medication in lower-income nations.
The announcement comes shortly after Gilead confronted stress to open lenacapavir to a patent pool that may permit generics to be offered beneath license in these nations.
The antiretroviral drug has been hailed as a possible game-changer within the struggle towards HIV, with early trials discovering the therapy one hundred pc efficient in stopping HIV an infection.
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With Wednesday’s announcement, generics corporations will have the ability to make a lower-cost model of the HIV prevention routine, topic to regulatory approvals, in 120 nations.
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“Gilead groups have been working with urgency to carry on high-volume generic producers now,” to allow them to begin manufacturing the drug after receiving approvals, stated Gilead CEO Daniel O’Day.
In July, researchers estimated that lenacapavir – which prices sufferers greater than $40,000 per individual a yr in a number of nations – may very well be made for as little as $40.
The drug solely must be injected twice a yr, making it a lot simpler to manage than present regimens requiring every day capsules.
HIV-prevention drug: Turning the tide
Worldwide well being company Unitaid stated Wednesday that it welcomed Gilead’s announcement, including that it was “ready to speculate instantly and collaborate to fast-track entry to lenacapavir.”
“It is a doubtlessly game-changing medicine that would dramatically flip the tide towards HIV infections, and we should guarantee, directly, international entry to lenacapavir for all those that want it,” stated Unitaid government director Philippe Duneton.
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There have been 1.3 million new HIV infections in 2023, whereas 39 million persons are dwelling with the virus, in line with the World Well being Group.
The licensees introduced on Wednesday embody corporations in India and Pakistan, in line with Gilead.
Based mostly on knowledge from its trials, Gilead is starting a sequence of regulatory filings by the of finish this yr, it stated.
“The agreements had been signed upfront of any international regulatory submissions to allow these nations to rapidly introduce generic variations of lenacapavir for HIV prevention, if accepted,” it added of the six licensing offers.
The corporate can also be prioritizing registration in 18 high-incidence nations together with Ethiopia, Kenya, South Africa, Thailand and Vietnam, to offer Gilead-supplied lenacapavir till generic variations can be found.
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In July, Liverpool College researcher Andrew Hill informed Agence France-Presse that if the drug was given to folks at excessive threat of contracting HIV, it may “principally shut down HIV transmission.”
