Dr Reddy’s ties up with Gilead to manufacture, commercialise HIV drug
As per the agreement, Dr Reddy’s will be responsible for technology transfer at its manufacturing site.
Dr Reddy’s Laboratories on Wednesday said it has tied up with Gilead Sciences for the manufacture and commercialisation of the HIV drug Lenacapavir in India and 120 other countries.
The company has entered into a royalty-free non-exclusive voluntary licensing agreement with Gilead Sciences Ireland UC for the drug, the Hyderabad-based drug maker said in a statement.
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Lenacapavir is a US Food and Drug Administration (USFDA) approved drug indicated for the treatment of human immunodeficiency virus a type 1 (HIV-1) infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
Additionally, Lenacapavir is currently under investigation for the prevention of HIV (PrEP) which is yet to be approved globally.
Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the US and Europe markets in the year 2022.
As per the agreement, Dr Reddy’s will be responsible for technology transfer at its manufacturing site, conducting bioequivalence/clinical studies, product registration and launch in the agreed markets, it said.
Additionally, the agreement grants licence to the drug maker to manufacture and commercialise Lenacapavir for the indication of prevention of HIV (PrEP) in 120 countries, if approved, it added.
“The collaboration with Gilead will help us make this latest treatment option available to patients in 120 primarily low- and lower- middle income countries, including in India,” Dr. Reddy’s Laboratories CEO API and Services Deepak Sapra said.
Many of these countries have a very high disease burden of HIV, he added.
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First Published: Oct 02 2024 | 8:05 PM IST