Dr. Reddy’s signs voluntary licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir in India and other countries
October 02 2024 - 11:10AM
Business Wire
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, NSEIFSC: DRREDDY; along with its subsidiaries together
referred to as “Dr. Reddy’s”), today announced that it has entered
into a royalty-free non-exclusive voluntary licensing agreement
with Gilead Sciences Ireland UC for the manufacture and
commercialisation of the drug, Lenacapavir, in India and 120 other
countries.
Lenacapavir is a United States Food and Drug Administration
(USFDA) approved drug indicated for the treatment of human
immunodeficiency virus type 1 (HIV-1) infection in heavily
treatment-experienced adults with multidrug 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 United States and Europe markets in the year 2022.
It is a first-in-class HIV-1 capsid inhibitor.
Dr. Reddy’s has been granted a non-exclusive voluntary licence
to manufacture Lenacapavir and market it in 120 countries, for the
current approved indication of HIV treatment in heavily
treatment-experienced (HTE) adults with multi-drug resistant HIV.
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.
Additionally, the agreement grants licence to Dr. Reddy’s to
manufacture and commercialise lenacapavir for the indication of
prevention of HIV (PrEP) in 120 countries, if approved.
Deepak Sapra, Chief Executive Officer- API and Services, Dr.
Reddy’s Laboratories Ltd., said: "Lenacapavir marks an
important milestone for Dr. Reddy’s in patient access and
affordability for pre and post exposure treatment of HIV. 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. Many of these
countries have a very high disease burden of HIV. This is an
important endeavour in our journey to create impact on 1.5 billion
patients by 2030."
About Lenacapavir:
Lenacapavir is approved in multiple countries for the treatment
of adults with multi-drug resistant HIV in combination with other
antiretrovirals. The use of lenacapavir for HIV prevention is
investigational and the safety and efficacy of lenacapavir for this
use have not been established.
The multi-stage mechanism of action of lenacapavir is
distinguishable from other currently approved classes of antiviral
agents. 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.
Lenacapavir is being evaluated as a long-acting option in
multiple ongoing and planned early and late-stage clinical studies
in Gilead's HIV prevention and treatment research program.
Lenacapavir is being developed as a foundation for potential future
HIV therapies with the goal of offering both long-acting oral and
injectable options with several dosing frequencies, in combination
or as a mono agent, that help address individual needs and
preferences of people and communities affected by HIV1.
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE:
500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global
pharmaceutical company headquartered in Hyderabad, India.
Established in 1984, we are committed to providing access to
affordable and innovative medicines. Driven by our purpose of ‘Good
Health Can’t Wait’, we offer a portfolio of products and services
including APIs, generics, branded generics, biosimilars and OTC.
Our major therapeutic areas of focus are gastrointestinal,
cardiovascular, diabetology, oncology, pain management and
dermatology. Our major markets include – USA, India, Russia &
CIS countries, China, Brazil and Europe. As a company with a
history of deep science that has led to several industry firsts, we
continue to plan ahead and invest in businesses of the future. As
an early adopter of sustainability and ESG actions, we released our
first Sustainability Report in 2004. Our current ESG goals aim to
set the bar high in environmental stewardship; access and
affordability for patients; diversity; and governance. For more
information, log on to: www.drreddys.com.
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on
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INVESTOR RELATIONS RICHA PERIWAL richaperiwal@drreddys.com
MEDIA RELATIONS USHA IYER USHAIYER@DRREDDYS.COM
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