The Long-Acting Therapeutics Patents and Licensing Database (LAPaL) is the only publicly available database dedicated to providing comprehensive data on long-acting medicinal products and extended-release drug delivery technologies available worldwide. This open-access, collaborative resource aims to facilitate partnerships in the long-acting therapeutics space and to promote access to these health interventions. LAPaL includes detailed information on the main characteristics of the drugs and drug technologies and an overview of their intellectual property, clinical trials landscape as well as information on their national filings.[1] [2] [3]. With support from Unitaid, it was launched in 2021 by the Medicines Patent Pool [4]. Additional funding was received from the NIH through the LEAP program. LAPaL offers comprehensive and up-to-date information on the technical specifications, developmental progress, and intellectual property (IP) status of a selection of long-acting treatments to improve health outcomes in low- and middle-income nations. The primary interest of LAPaL are long-acting therapeutics. These are formulations of medicines that elicit less frequent administration while maintain a safe and effective dosing to treat or prevent a set of conditions. Long-acting formulations are often an important alternative that can be attractive for health care providers, persons receiving the medications and their caregivers. The potential benefits of long-acting therapeutics include enhanced adherence to the prescribed regimen, improved clinical efficacy, and in some instances, improved safety, and decrease in the relapse rates [5]. LAPaL covers a wide array of heath areas, including HIV, malaria, hepatitis, respiratory syncytial virus, mental health disorders and other indications.

Aims and objective

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The main aim of the LAPaL database is to provide verified open-access information on pharmacological features and intellectual property status of a selection of long-acting therapeutics and their potential applications [1].

Components

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Long-acting platform technologies

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Long-acting platform technologies that are included in LAPaL elicit a sustained release or prolonged therapeutics activity of medicines. Their features are displayed, as well as information on their intellectual property landscape, and studied applications, when these are in the public domain. The technologies entries are initiated by the technology manufacturer, main sponsor, or by LAPAL team. An overview of the various technologies features, including comparisons of the studied or approved routes of administration, therapeutic applications, as well as advancement in the clinical pipeline are showcased [2].

Compounds with extended-release formulations

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The database includes compounds with a prolonged half-life and a sustained release profile, with dosing schedules ranging from once a week to once a year. Alternatively, it includes compounds that are being studies, developed or approved for use in a long-acting eliciting formulation, at times, in combination with a long-acting platform [1]. Compounds are categorised into small molecules and biotherapeutics. Given the trend in clinical developments and the potential for global impact, the database is currently witnessing an increase in the biotherapeutics:small molecules entries ratio [6].

Clinical trials updates and in-country regulatory approvals

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The LAPaL website provides extensive in-country regulatory approvals and globally registered clinical trials information on marketed and investigational long-acting therapeutics, serving as a reliable technical resource for communities living with or at risk of the conditions covered, healthcare professionals, innovators, researchers, manufacturers, government bodies, civil society and funders interested in prolonged and sustained-release therapeutics [1] [2]. The participatory nature of LAPaL allows users to register and propose additions to the database. So to consolidate the global regulatory approval status of LA drugs, there is a landscape created in the LAPaL website that allows users to toggle in the world map and identify individual LA drug approvals [1].

Database highlights and added value

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  • Comprehensive descriptions: LAPaL provides detailed information on a wide range of hand-picked long-acting compounds, technologies and formulations, including their physico-chemical characteristics, the mechanism of action, intellectual property landscape, the registered clinical trials and regulatory approval status when relevant.
  • Search and Filter Capabilities: Users can search for specific compounds or technologies using various filters, such as therapeutic area, route of administration, targeted population, and frequency of administration. They can apply various filters to surface the therapeutics corresponding to their particular interest. This feature enables LAPAL users to access relevant information quickly and seamlessly [1].
  • Comparison tool: Similar to an online product comparator, LAPaL includes a feature where users can see side by side selected long-acting therapeutics and compare their characteristics.
  • User-Friendly Interface: The database features an easy-to-use interface that facilitates navigation and enhances user experience. Information is organized clearly, allowing users to find the required details efficiently[7]. Feedback is collected regularly to keep improving user experience while increasing the type and amount of data available.
  • Patent and Licensing Information: Relevant patents to the long-acting therapeutics and their use are listed, together with the publicly available information on any licencing deals and patent expiry dates. Users can find a summary of patent status globally, classified by countries income levels [8]. LAPaL’s intellectual property data are additionally curated by a dedicated team at MPP and powered by the algorithms and intellectual property data sourcing mechanisms of MedsPaL [9] [10][11] [12].
  • Regular updates: New long-acting therapeutics entries, compounds and technologies, are regularly added to LAPaL, ensuring users have access to the latest information. Furthermore, the database is regularly updated to reflect new clinical trials, in-country approvals and key clinical results. Additional patents and changes in patent status are also monitored. The data curators of the University of Liverpool are responsible for updating the scientific content in the database [13].
  • Educational Resources: The website offers educational resources to professionals with varying levels of experience, such as a compilation of key scientific or institutional publications, links to other organisations and projects if interest in the long-acting space.

Funding and collaboration

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LAPaL is a collaborative initiative funded by Unitaid and coordinated by the Medicines Patent Pool (MPP) . It also receives funding from National Institute of Health (NIH) through the Long-Acting/Extended Release Antiretroviral Research Resource Program (LEAP) and in partnership with the University of Liverpool. Unitaid is a non-for profit dedicated to making new health products available and affordable for people in low- and middle-income countries. The LEAP programme is dedicated to advancing antiretroviral research and development, particularly long-acting or extended-release treatments and prevention options, as these formulations elicit the maintenance of therapeutic drug levels over long periods[14]

Conclusion

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The Long-Acting Therapeutics Patents and Licensing Database is a valuable resource for scientists, civil society, governmental bodies, investors and communities affected by the conditions covered in the database. By providing comprehensive and up-to-date open-access information on long-acting therapeutic medicines and technologies, LAPaL supports the development of medications that may support people receiving them in following the prescribed regimen, and therefore elicit better health outcomes. The database's dedicated team, is constantly improving the tool and user-friendly interface while carefully curating an growing listing of entries, making LAPAL a unique resource tool to foster innovation in long-acting therapeutics development, with expanded access in mind.

References

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  1. ^ a b c d e f "LAPaL Official Website".
  2. ^ a b c "LAPaL - Free Therapeutics Patents Database - MPP". 14 February 2022.
  3. ^ "The Long-Acting Therapeutics Patents and Licenses Database (LAPaL)". PrEPWatch.
  4. ^ "Unitaid - LAPaL, the Long-Acting Therapeutics Patents and Licences Database, is now available with enhanced features to track new drug development".
  5. ^ Rubens, Hannah (7 July 2022). "The Long-Acting Technologies Patents and Licenses Database". The IMPT.
  6. ^ C, Flexner (2019). "Creating demand for long-acting formulations for the treatment and prevention of HIV, tuberculosis, and viral hepatitis". Current Opinion in HIV and AIDS. 14 (1): 13–20. doi:10.1097/COH.0000000000000510. PMID 30394948.
  7. ^ "Privacy Policy of LAPaL" (PDF). Medicine Patent Pool.
  8. ^ Braimoh, Tiwadayo; Burrone, Esteban; Gore, Charles; Vijayaraghavan, Pushpa (2 July 2024). "Intellectual property licensing of therapeutics during the COVID-19 crisis: lessons learnt for pandemic preparedness and response". Globalization and Health. 20 (1): 52. doi:10.1186/s12992-024-01057-5. PMC 11221111. PMID 38956614.
  9. ^ "MPP Home - The Medicines Patent Pool".
  10. ^ Gaayeb, Lobna; Das, Aditi; James, Ike; Murthy, Rajesh; Nobre, Sandra; Burrone, Esteban; Morin, Sébastien (July 2023). "Voluntary licensing of long-acting HIV prevention and treatment regimens: using a proven collaboration- and competition-based mechanism to rapidly expand at-scale, sustainable, quality-assured and affordable supplies in LMICs". Journal of the International AIDS Society. 26 (S2): e26092. doi:10.1002/jia2.26092. ISSN 1758-2652. PMC 10339000. PMID 37439078.
  11. ^ "MedsPaL". MedsPaL.
  12. ^ Morin, Sébastien; Segafredo, Giulia; Piccolis, Manuele; Das, Aditi; Das, Meghmala; Loffredi, Nicola; Larbi, Amina; Mwamelo, Kim; Villanueva, Elena; Nobre, Sandra; Burrone, Esteban (January 2023). "Expanding access to biotherapeutics in low-income and middle-income countries through public health non-exclusive voluntary intellectual property licensing: considerations, requirements, and opportunities". The Lancet Global Health. 11 (1): e145–e154. doi:10.1016/S2214-109X(22)00460-0. PMID 36455593.
  13. ^ "LONGEVITY Project - Centre of Excellence for Long-acting Therapeutics". University of Liverpool.
  14. ^ "LEAP | Home". longactinghiv.org.