Through Cipla’s voluntary licensing agreement with Merck (MSD), Cipla may support potential future access to generic alimatravir, an investigational medicine being studied for HIV-1 pre-exposure prophylaxis (PrEP).
The announcement underscores Cipla’s role in supporting responsible partnerships at a critical moment for the global HIV response, as global leaders, researchers and healthcare professionals convene in Brazil this week for the world’s largest HIV and AIDS conference.
Through the agreement, Cipla may produce generic alimatravir following completion of development, applicable regulatory approvals, technology-transfer requirements and any other country-specific requirements. The voluntary licensing agreement builds on Cipla’s vertically integrated capabilities across the pharmaceutical value chain, enabling the company to support the development and manufacturing activities, under the terms of the agreement.
As one of Africa’s leading pharmaceutical companies, Cipla has contributed to improving access to critical HIV medicines and prevention-related public-health programmes across the continent. In the early 2000s, Cipla made quality, affordable antiretrovirals available at less than $1 per day, contributing to wider access to HIV treatment during a critical period in the global HIV response.
Building on this legacy, Cipla continues to strengthen its contribution to public health through the development, manufacture and distribution of high-quality, affordable medicines that support national and regional HIV priorities, where such medicines are appropriately authorised and supplied in accordance with local requirements.
Paul Miller, CEO of Cipla Africa, said: “Cipla’s vision has always been to make quality healthcare more accessible for patients who need it most. This licensing agreement reflects our long-standing commitment to supporting responsible innovation in HIV prevention for the patients and communities we serve. We believe that expanding future access, where permitted by applicable regulatory requirements, requires extensive manufacturing expertise, reliable supply chains and strategic partnerships that can translate scientific innovations into real-world impact.”
Investment in Local Manufacturing, Sustainable Access
Cipla’s manufacturing network and established presence across African markets position the company to support widespread, sustainable access to HIV medicines. Through decades of experience in producing and supplying medicines at scale, Cipla has helped strengthen healthcare systems and HIV treatment programmes.
The company also remains committed to supporting local healthcare priorities by investing in local manufacturing capabilities and working collaboratively with governments and healthcare professionals to improve access to life-saving medicines. Cipla has been supplying the South African government with equitable access to HIV medication for a number of years. These efforts align with broader ambitions to strengthen pharmaceutical manufacturing capacity on the continent, reinforcing Cipla’s commitment to secure and ensure reliable ARV supply.
Most recently for example, Cipla made significant investments in its local manufacturing facility, upgrading the capacity of the ARV production line with the installation of a new Countec bottle line and increased its tablet filing capacity by 190%. The company is able to locally produce 475 million ARV tablets annually and has upscaled its manufacturing capabilities to ensure sufficient capacity to meet current demand and support near‑term growth, ensuring continuity of supply. Cipla’s overall manufacturing capacity is 1,625 billion tablets annually.
“With a long history of leadership in HIV treatment and prevention, Cipla remains dedicated to helping shape a future where innovative healthcare solutions are accessible, affordable and available to communities across Africa. We want people to live a long and healthy life as part of our ethos of caring for life,” said Paul Miller, CEO of Cipla Africa.
*According to Statistics South Africa, the number of people living with HIV in the country is estimated to be approximately 8 million (12,7% of the population)[1].
Important regulatory notice: Alimatravir is an investigational medicine. It is not registered by the South African Health Products Regulatory Authority (SAHPRA), has not been approved for sale or supply in South Africa, and is not currently available in South Africa. Its safety, quality and efficacy have not been evaluated or approved by SAHPRA. This communication is a corporate announcement about a voluntary licensing agreement and is not intended to promote, recommend or encourage the use of any medicine.
Alimatravir remains investigational and no claims are made regarding its safety, efficacy or suitability. No availability in South Africa is implied by this announcement. Any future availability remains subject to successful completion of development, regulatory approval and applicable local authorization requirements.
[1] Source: https://www.gov.za/faq/health/where-can-i-find-latest-hiv-and-aids-statistics-south-africa
