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Draft:LAPaL

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The Long-Acting Therapeutics Patents and Licensing Database (LAPaL) is a publicly available database dedicated to providing comprehensive data on long-acting medicinal products and extended-release drug delivery technologies worldwide. This open-access, collaborative resource aims to facilitate partnerships in the long-acting therapeutics space and to improve access to these health interventions. LAPaL includes 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. With support from Unitaid, it was launched in 2021 by the Medicines Patent Pool.[1]. 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 is long-acting therapeutics [2]. These formulations of medicines elicit less frequent administration while maintaining safe and effective dosing to treat or prevent a set of conditions. Long-acting formulations are often an important alternative 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 a decrease in the relapse rates [3]. LAPaL covers a wide array of health areas, including HIV, malaria, hepatitis, respiratory syncytial virus, mental health disorders, and other indications [4].

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]. To utilize advanced algorithms and data sourcing mechanisms for accurate intellectual property information.

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 technology entries are initiated by the technology manufacturer, main sponsor, or 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 [4].

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 studied, developed or approved for use in a long-acting eliciting formulation, at times, in combination with a long-acting platform [5]. Compounds are categorized 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 database contains global 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 [5]. In the database, external users can register and propose additions to the database. There is a landscape created in the LAPaL website that allows users to toggle in the world map and identify individual LA drug approvals. This landscape illustrates the global regulatory in-country approvals, clinical trial details like mean age, gender, and other details [4] [5].

Database highlights and added value

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  • Comprehensive Listings: LAPaL provides comprehensive information on a range of long-acting compounds, technologies, and formulations, including their physico-chemical characteristics, mechanisms of action, intellectual property landscape, registered clinical trials, and regulatory approval status where applicable [7].
  • Search and Filter Capabilities: The platform allows users to search for specific compounds or technologies using various filters such as therapeutic area, route of administration, targeted population, and frequency of administration. This functionality supports the retrieval of relevant information [1].
  • Comparison tool: Similar to an online product comparator [8], LAPaL included a feature where users can see side-by-side selected long-acting therapeutics and compare their characteristics.
  • User Interface: The database features a simple interface that facilitates navigation. Information is organized allowing users to find the required details.
  • Patent and Licensing Information: The database also contains detailed information on patents relevant to long-acting therapeutics, including details on licensing deals and patent expiry dates. Users can access summaries of global patent statuses, classified by country income levels. [9]. Intellectual property data is curated by a team at MPP and supported by MedsPaL’s algorithms and data sourcing mechanisms [10] [11][12] [13].
  • Regular updates: New long-acting therapeutics entries, compounds, and technologies, new clinical trials, in-country approvals, and key clinical results are updated by a team of data curators at the University of Liverpool. Additional patents and changes in patent status are also monitored. The data curators of the University of Liverpool are responsible for the scientific content in the database [14].
  • Educational Resources: The website also contains educational resources for professionals with varying levels of experience, such as a compilation of key scientific or institutional publications, and links to other organizations and projects if interested in the long-acting space [7].

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 the National Institute of Health (NIH) through the Long-Acting/Extended Release Antiretroviral Research Resource Program (LEAP) and in partnership with the University of Liverpool and AIDS Vaccine Advocacy Coalition (AVAC)[15]. Unitaid is a not-for-profit dedicated to making new health products available and affordable for people in low- and middle-income countries [16]. The LEAP program 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[17]

References

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  1. ^ a b c "Unitaid - LAPaL, the Long-Acting Therapeutics Patents, and Licences Database, is now available with enhanced features to track new drug development".
  2. ^ Rubens, Hannah (7 July 2022). "The Long-Acting Technologies Patents and Licenses Database". The IMPT. Retrieved 16 Jul 2024.
  3. ^ Abdelkader, Hamdy; Al-Fatease, Adel, eds. (24 November 2023). Recent Advances in Long-Acting Drug Delivery and Formulations. MDPI - Multidisciplinary Digital Publishing Institute. doi:10.3390/books978-3-0365-9438-5. ISBN 978-3-0365-9439-2. Retrieved 16 Jul 2024.
  4. ^ a b c "LEAP | LAPaL, the Long-Acting Therapeutics Patents and Licences Database, is now available with enhanced features to track new drug development". longactinghiv.org.
  5. ^ a b c "Spotlight on New PrEP Tools and Data: From R&D to access". AVAC.
  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. ^ a b "NEWS- LAPaL: a one-stop shop for long-acting therapeutics insights - MPP". Medicine Patent Pool. Retrieved 16 Jul 2024.
  8. ^ "PriceSpy Ltd". PriceSpy UK.
  9. ^ 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.
  10. ^ "MPP Home - The Medicines Patent Pool".
  11. ^ 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.
  12. ^ "MedsPaL". MedsPaL.
  13. ^ 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.
  14. ^ Olagunju, Adeniyi. "Perinatal Pharmacology Group". Centre of Excellence for Long-acting Therapeutics. University of Liverpool. Retrieved 15 Jul 2024.
  15. ^ "The Long-Acting Therapeutics Patents and Licenses Database (LAPaL)". PrEPWatch. AVAC. Retrieved 16 Jul 2024.
  16. ^ "Unitaid Official Website". Unitaid Official Website. Retrieved 16 Jul 2024.
  17. ^ "LEAP | Home". longactinghiv.org.
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