Geneva, 13 September 2021 – Development is underway based on an agreement launched in June 2021 between Unitaid, the Clinton Health Access Initiative (CHAI), and pharmaceutical manufacturer Laurus Labs to accelerate the development, commercialization, and registration of the best-in-class second- and third-line HIV treatment darunavir boosted with ritonavir (DRV/r) for children.
Despite being available in high-income countries for over a 15-year period, a generic, fixed-dose combination pediatric version of DRV/r is still not available. Through this agreement, Unitaid and CHAI are working with Laurus Labs to finally address this critical need and ensure CLHIV (Children Living with HIV/AIDS) have access to high-quality second- and third-line HIV treatment.
Unitaid Executive Director Dr. Philippe Duneton said, “Enabling children and young people to have access to the best possible HIV treatment is a key priority for Unitaid – whether that’s first, second, or third-line treatment. This agreement is a welcome step towards having a long-awaited pediatric formulation of DRV/r available, as we strive to achieve the global goal of 90% of people living with HIV receiving antiretroviral therapy.”
Second- and third-line therapies are critical for CLHIV where the World Health Organization (WHO)-recommended first-line treatment dolutegravir (DTG) may not be an option due to medication resistance or intolerance.
Currently available second- and third-line treatments are often difficult for children to take due to bitter taste and difficult forms of administration.
“A pediatric version of DRV/r has been a global health priority since 2013, but is still not available, leaving thousands of children without the lifesaving medication they need,” said Ann Veneman, interim Co-CEO of CHAI. “The innovative incentive program announced today will enable development of an effective pediatric medication that will save the lives of children living with HIV.”
The product development collaboration between Unitaid, CHAI, and Laurus Labs was spearheaded through Unitaid’s investment in CHAI since 2016 to bring the best HIV medications to market more quickly and integrate them into treatment programs in low- and middle-income countries that need them the most.
Understanding the small market size for a pediatric version of DRV/r, the initiative has provided Laurus with a financial incentive for a portion of their development and commercialization costs. CHAI will work closely with Laurus Labs to provide technical and regulatory support to enable accelerated generic development and regulatory submission of the medication.
Commenting on the collaboration in development of the new second line and third line pediatric treatment, Dr. Satyanarayana Chava, Founder & CEO, Laurus Labs, said, “we are excited about this innovative mechanism to accelerate the availability of pDRV/r regimen for children living with HIV.
The collaboration between Laurus Labs, CHAI, and Unitaid can positively impact over 100,000 CLHIVs and help them in leading a better life especially in their formative years.”
Background on DRV/r
DRV/r is a best-in-class protease inhibitor that has been shown to effectively treat HIV in children who are just beginning treatment, or whose treatment is no longer working. The WHO-led Pediatric Antiretroviral Drug Optimization (PADO) group, which establishes and reviews priorities for drug development for pediatric HIV treatment and prevention, lists pediatric DRV/r 120/20mg as a priority formulation to provide robust treatment for second- and third-line use after failure on DTG-based regimens. Despite being listed as a PADO priority since 2013, a pediatric version of DRV/r has not yet been developed.
About Unitaid
Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV/AIDS, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities such as cervical cancer and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator. Unitaid is hosted by the World Health Organization.
About CHAI
The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to saving lives and reducing the burden of disease in low-and middle-income countries. CHAI works with its partners to help strengthen the capabilities of governments and the private sector to create and sustain high-quality health systems that can succeed without our assistance.
About Laurus
Laurus Labs is a fully integrated pharmaceutical and biotechnology company, with a leadership position in generic Active Pharmaceutical Ingredients (APIs) with a major focus on Anti-Retro Viral, Hepatitis-C, Cardiovascular, Anti-Diabetic, Central Nervous System (CNS), Proton Pump Inhibitors (PPIs) and Oncology drugs. Laurus Labs also develops and manufactures oral solid formulations, provides contract research and manufacturing services (CRAMS) to Global pharma companies, and produces specialty ingredients for nutraceuticals, dietary supplements and cosmeceuticals. Laurus Labs works on animal origin-free recombinant proteins in biotechnology.
Media contacts
For more information and media requests:
Clinton Health Access Initiative
Regan Lachapelle, Chicago, tel. +1 857-208-2788, rlachapelle@clintonhealthaccess.org
Unitaid
Maggie Zander, Geneva, tel. +41 79 593 17 74, zanderm@unitaid.who.int
Laurus Labs
Pavan Kumar N, Hyderabad, India, tel. – +91 7337353848, pavankumar.n@lauruslabs.com
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