Gilead Secures Licensing Deal for New HIV Medication in Developing Nations

Gilead Secures Licensing Deal for New HIV Medication in Developing Nations

Gilead Secures Licensing Deal for New HIV Medication in Developing Nations

Dive Brief:

  • On Wednesday, Gilead announced the establishment of royalty-free licensing agreements with six generic pharmaceutical companies to manufacture and distribute its HIV treatment lenacapavir in regions with high HIV prevalence and limited financial resources.
  • This announcement comes as Gilead prepares to seek regulatory approval for lenacapavir as a preventive measure. Acknowledging the lengthy regulatory and manufacturing processes, the company is prioritizing application submissions in 18 countries across Africa and Southeast Asia, which bear a significant portion of the global HIV burden.
  • The agreements include lenacapavir’s use for preventive measures as well as for treatment in adults facing multi-drug resistant HIV, a treatment that has already received approval in the U.S. and Europe.

Dive Insight:

Many lower- and middle-income nations face challenges due to limited resources for acquiring essential medications at the prices established in more affluent markets like the U.S. and Europe. Organizations such as the World Health Organization and the Medicines Patent Pool are striving to resolve this disparity, while pharmaceutical companies explore various licensing frameworks.

Gilead has engaged in similar licensing arrangements previously. For instance, in 2017, the company collaborated with the Medicines Patent Pool to license its older HIV medication, bictegravir. Additionally, early in the COVID-19 pandemic, it allowed five generic manufacturers to produce and distribute its antiviral drug remdesivir in 127 lower and middle-income countries royalty-free for a designated period.

Gilead is known for its extensive range of HIV treatments, and with the introduction of lenacapavir, it strives to enhance the options available to healthcare providers. The company aims to initiate global regulatory submissions for lenacapavir as a pre-exposure prophylaxis (PrEP) by late 2024.

This year, Gilead presented encouraging results from two Phase 3 trials evaluating lenacapavir as a biannual injection in cisgender women and in cisgender men and gender-diverse individuals, showcasing its effectiveness in preventing infections across both demographics.

Public Citizen, an advocacy organization, labeled Gilead’s announcement as a “noteworthy yet imperfect” advancement. In a statement, Peter Maybarduk, director of Public Citizen’s access to medicines initiative, noted, “Gilead is licensing at an early stage to multiple manufacturers and intends to provide lower pricing until they commence production. However, it is regrettable and unclear why Gilead chose not to utilize an independent licensing authority like the Medicines Patent Pool.”

Despite the efficacy of treatments from Gilead and other firms, HIV continues to pose a critical public health challenge, particularly in regions deeply affected by the virus, such as various African countries. The burden of HIV/AIDS varies significantly across areas.