Dr Reddy’s, Gilead sign licence pact for investigational once-yearly HIV prevention drug
Hyderabad, Sept 17 (TNT): Dr Reddy’s Laboratories on Thursday said it has entered into a royalty-free, non-exclusive voluntary licensing agreement with Gilead Sciences for investigational once-yearly lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP).
The agreement expands an existing voluntary licensing arrangement between the two companies signed in October 2024, covering twice-yearly lenacapavir for HIV prevention and treatment, Hyderabad based pharma giant said in a release.
Under the latest agreement, Dr Reddy’s will work towards manufacturing readiness, technology transfer and future supply planning for once-yearly lenacapavir, subject to regulatory approval.
Clinical development of the drug will continue in licensed territories, primarily low- and lower-middle-income countries, the company said.
Dr Reddy’s said the collaboration would further strengthen its Public Health Access portfolio, which focuses on improving access to medicines for communicable diseases and reproductive, maternal and child health.
Once-yearly lenacapavir is currently being evaluated in Gilead’s Phase 3 PURPOSE 365 study. The drug remains investigational for once-yearly HIV prevention and has not been approved by any regulatory authority for this indication.
“If approved, once-yearly lenacapavir could provide an additional long-acting HIV prevention option, particularly for people and regions where access and adherence to existing prevention methods remain challenges,” the company said.
Dr Reddy’s CEO, API and Services, Deepak Sapra, said the latest agreement builds on the companies’ existing collaboration and supports global HIV prevention efforts.
Lenacapavir is already approved in multiple countries for treating adults with multi-drug-resistant HIV in combination with other antiretroviral medicines.
Twice-yearly lenacapavir for HIV prevention has also received approval from the US Food and Drug Administration and the European Medicines Agency. The World Health Organisation has recommended twice-yearly lenacapavir for HIV prevention.
Dr Reddy’s, however, noted that the safety and efficacy of once-yearly lenacapavir for HIV prevention have not yet been established.
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