On Wednesday, Gilead Sciences, a US-based pharmaceutical company, issued royalty-free licenses to 6 generic drug manufacturers, allowing them to manufacture and sell affordable generic versions of its HIV prevention medicine in 120 low- and lower-middle-income countries.
Additionally, Gilead also plans to supply these companies with the branded version of the drug, lenacapavir, in 18 countries, including Botswana, Ethiopia, and Kenya, until they set up manufacturing capacity to meet demand. These countries account for ~70 percent of HIV cases.
About the Drug:
Lenacapavir is a United States Food and Drug Administration (USFDA) approved medication for treating human immunodeficiency virus type 1 (HIV-1) infection in adults who have extensive treatment experience and are dealing with multidrug-resistant strains that are not responding to their current antiretroviral therapy due to issues like resistance, intolerance, or safety concerns.
Moreover, Lenacapavir is being studied for its potential use in HIV prevention, although it has not yet received global approval for this application.
Gilead Sciences first launched Lenacapavir under the brand name “Sunlenca” in the U.S. and European markets in 2022, marking it as a pioneering HIV-1 capsid inhibitor.
What’s the News:
These agreements come in response to pressure from activists and civil rights groups and enable the production and distribution of generic lenacapavir, pending approval, in 120 countries, including India, Ukraine, the Philippines, and Thailand.
However, the People’s Medicines Alliance, an advocacy group, criticised Gilead for excluding several countries, particularly in Latin America, from these agreements.
The deal also covers lenacapavir as a treatment for adults with HIV who have multi-drug-resistant strains and have previously been treated with multiple medications.
In the U.S., the drug is approved for this purpose and is marketed under the brand name “Sunlenca,” with an annual list price of $42,250.
Among the 6 generic drug manufacturers involved are Mylan (a unit of US-based Viatris), Egypt’s Eva Pharma, and Ferozsons Laboratories of Pakistan.
The following are the remaining 3 Indian pharmaceutical companies have also signed licensing agreements with Gilead:
Dr Reddy’s Laboratories Limited
With a market cap of Rs. 1.13 lakh crores, the stock surged marginally by 0.8 percent to Rs. 6,796.6 on BSE, during Thursday’s trading session.
According to the latest regulatory filings, Dr Reddy’s Laboratories Limited 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.
The stock has delivered positive returns of nearly 24 percent in one year, as well as around 16.4 percent returns year-to-date.
Dr. Reddy’s Laboratories Limited offers a portfolio of products and services, including Active Pharmaceutical Ingredients (APIs), generics, biosimilars and differentiated formulations through its three businesses: Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products,
Emcure Pharmaceuticals Limited
With a market cap of Rs. 28,042.3 crores, the stock surged nearly 0.8 percent to Rs. 1,504.75 on BSE, during Thursday’s trading session.
According to the latest regulatory filings, Emcure Pharma will play a crucial role in ensuring the availability of high-quality, low-cost versions of lenacapavir in 120 countries, primarily in low- and lower-middle-income regions.
“As the leader in HIV antiviral segment in covered market in India with long standing experience in supplying HIV medicines to over 100 LMIC countries, Emcure is uniquely positioned to drive impactful change in the global fight against HIV,” the company’s MD & CEO commented.
The stock has delivered positive returns of nearly 9 percent returns since the date of listing.
Established in 1981, Emcure Pharmaceuticals Ltd. is engaged in the business of developing, manufacturing and globally marketing a broad range of pharmaceutical products. It is ranked as the 12th largest pharma company in India in terms of Domestic Sales for MAT June 2024.
Hetero Labs
Hetero Labs is one of the world’s leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with a presence in more than 140 countries. It is not publicly traded on any stock exchange.
The company serves 40 percent of the existing global demand for Anti-Retroviral (ARV) APIs and Finished Dosage Forms (FDFs) used in HIV/AIDS treatment.
Hetero Drugs Limited and Hetero Labs Limited are the flagship companies of Hetero Group headquartered in Hyderabad, India.
The company have a global presence with 15 API facilities, 21 formulation facilities, and three R&D facilities.
Written by Shivani Singh
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