HYDERABAD: Dr Reddy’s Laboratories and Hetero are amongst half a dozen generic drug makers to have entered into non-exclusive, royalty-free voluntary licencing agreements with Gilead Sciences Ireland UC to fabricate and distribute the latter’s human immunodeficiency virus (HIV) drug Lenacapavir in India and 120 low- and middle-income international locations (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 below the model identify Sunlenca within the US and Europe in 2022. While most antivirals act on only one stage of viral replication, Lenacapavir is designed to inhibit HIV at a number of phases of its lifecycle and has no recognized cross resistance exhibited in vitro to different present drug courses, Gilead Sciences mentioned.
The licensee generic drugmakers will construct manufacturing capability for Lenacapavir, which has been authorised by the United States Food and Drug Administration (USFDA) for the therapy of closely treatment-experienced adults with multidrug resistant HIV-1 an infection.
While Lenacapavir has been authorised in a number of international locations for the therapy of adults with multi-drug resistant HIV together with different antiretrovirals, it’s also presently below investigation for the prevention of HIV pre-exposure prophylaxis (PrEP). Earlier this month, Gilead introduced promising outcomes from a pivotal Phase-3 medical trial that confirmed Lenacapavir diminished HIV infections by 96% in comparison with the background HIV incidence.
Gilead Sciences mentioned the agreements had been signed upfront of any world regulatory submissions to allow these international locations to shortly introduce generic variations of Lenacapavir for HIV prevention, if authorised.
Dr Reddy’s mentioned will probably be accountable for know-how switch at its manufacturing web site, conducting bioequivalence/medical research, product registration and launch within the agreed markets.
The Hyderabad-based firm mentioned the settlement additionally grants it a licence to fabricate and commercialise Lenacapavir for the indication of prevention of HIV (PrEP) in 120 international locations, if authorised.
Hetero Group managing director Dr Vamsi Krishna Bandi mentioned the corporate intends to leverage its robust analysis focus, manufacturing scale and distribution experience to broaden entry to Lenacapavir in all of the 120 excessive incidence useful resource restricted international locations.
