MSD shares high-value intellectual property assets to accelerate drug development for tuberculosis

Developing new drugs can often be challenging, time-consuming and uncertain. However, companies hold a wide array of intellectual property (IP) assets, which are valuable for product development, from unpublished clinical trial data to libraries of target-specific compounds.

When companies share these high-value assets for advancing drug development transparently with access-oriented organisations, it can reduce duplication of efforts and accelerate research and development of potential treatments that, if proven successful, can target diseases with high burdens.

Furthermore, such partnerships can improve access to these medicines in low-and middle-income countries (LMICs) once the drugs are approved, serving to improve global health outcomes in the long term.

In 2008, GSK already demonstrated that IP sharing could create a substantial impact when it partnered with Medicines for Malaria Venture (MVV) to develop tafenoquine as an anti-relapse medicine for Plasmodium vivax malaria. This collaboration led to increased availability of effective treatments in areas that faced a high burden of malaria. More recently, as identified in this iteration of the Index, GSK has newly engaged in 17 IP-sharing agreements with public research institutions and drug discovery, which include assets of high value during the period of analysis. However, GSK shares information under a non-disclosure agreement.

MSD demonstrates best practice in the 2024 Index by sharing its high-value IP assets, two antibacterial candidates targeting TB, with an access-oriented organisation and maintaining transparency about the process.

Best Practice  

TB is preventable and curable but remains one of the leading infectious causes of death globally. In 2022, it affected 10 million people and caused 1.3 million deaths worldwide. More than 80% of cases and deaths are in LMICs, mostly concentrated in 30 countries that face a disproportionately high burden of TB.¹ Organisations, including the World Health Organization (WHO) and Impact Global Health (formerly Policy Cures Research), have identified critical research gaps in product development for TB, such as the need for new treatments, more effective vaccines, and improved diagnostics.^2,3

Late in 2022, MSD announced an exclusive global licensing agreement with the Gates MRI for two preclinical candidates (MK-7762 and MK-3854). These were discovered by MSD scientists as part of the TB Drug Accelerator, a collaborative effort to create innovative therapeutic options.

Under the agreement, MSD will provide IP and Gates MRI will conduct non-clinical and clinical studies to evaluate candidates’ efficacy for new combination treatment regimens. With the burden of TB rising rapidly, and multidrug-resistant TB a major health challenge, leveraging expertise and resources could help MSD and Gates MRI tackle these issues and develop shorter, more effective and affordable regimens. Additionally, MSD publicly discloses information about its IP-sharing agreement on its website, supporting collective efforts in drug development.

Conclusion 

By sharing high-value IP assets that target TB, one of the world’s primary infectious killers, MSD aligns with global health priorities and stakeholder expectations and the company is helping to maximise the potential to develop affordable treatment regimens for TB, including drug-resistant strains.

Companies can emulate MSD’s transparent approach of sharing high-value IP assets for potential drug candidates that could address product gaps for specific diseases. By collaborating with access-oriented organisations in this way, pharmaceutical companies can help speed up drug development, which could in turn result in new, innovative, much-needed treatments making it to market in LMICs.

_{1. World Health Organization. Tuberculosis. Published November 7, 2023. Accessed August 27, 2024. https://www.who.int/news-room/fact-sheets/detail/tuberculosis}

_{2. World Health Organization. WHO Preferred Product Characteristics (PPCs). Accessed August 24, 2023. https://www.who.int/teams/immunization-vaccines-and-biologicals/product-and-delivery-research/ppcs.}

_{3. Policy Cures Research G-FINDER. Neglected Disease R&D Scope. 2023. Accessed August 24, 2023. https://gfinder.policycuresresearch.org/staticContent/pdf/G-FINDER_ND_R%26D_scope.pdf.}