HYDERABAD: Dr Reddy’s Laboratories and Hetero are among half a dozen generic drug makers to have entered into non-exclusive, royalty-free voluntary licencing agreements with Gilead Sciences Ireland UC to manufacture and distribute the latter’s human immunodeficiency virus (HIV) drug Lenacapavir in India and 120 low- and middle-income countries (LMICs).
Apart from Dr Reddy’s Labs and Hetero, Emcure, Eva Pharma, Ferozsons Laboratories Ltd and Mylan too have inked pacts with Gilead for the first-in-class HIV-1 capsid inhibitor that was launched under the brand name Sunlenca in the US and Europe in 2022. While most antivirals act on just one stage of viral replication, Lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes, Gilead Sciences said.
The licensee generic drugmakers will build manufacturing capacity for Lenacapavir, which has been approved by the United States Food and Drug Administration (USFDA) for the treatment of heavily treatment-experienced adults with multidrug resistant HIV-1 infection.
While Lenacapavir has been approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals, it is also currently under investigation for the prevention of HIV pre-exposure prophylaxis (PrEP). Earlier this month, Gilead announced promising results from a pivotal Phase-3 clinical trial that showed Lenacapavir reduced HIV infections by 96% compared to the background HIV incidence.
Gilead Sciences said the agreements were signed in advance of any global regulatory submissions to enable these countries to quickly introduce generic versions of Lenacapavir for HIV prevention, if approved.
Dr Reddy’s said it will be responsible for technology transfer at its manufacturing site, conducting bioequivalence/clinical studies, product registration and launch in the agreed markets.
The Hyderabad-based company said the agreement also grants it a licence to manufacture and commercialise Lenacapavir for the indication of prevention of HIV (PrEP) in 120 countries, if approved.
Hetero Group managing director Dr Vamsi Krishna Bandi said the company intends to leverage its strong research focus, manufacturing scale and distribution expertise to expand access to Lenacapavir in all the 120 high incidence resource limited countries.