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is MK-8527 and what stage is it in?","Question",{"text":63,"@type":64},"MK-8527 is a once-monthly oral PrEP candidate currently in Phase III clinical trials.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"Why does the letter stress accelerated and broad regulatory registration?",{"text":68,"@type":64},"It argues that rapid, simultaneous registration can overcome past availability and access delays, enabling LMICs to receive prevention tools at the same time as high-income countries.",{"name":70,"@type":61,"acceptedAnswer":71},"What pricing approach does the letter request from Merck?",{"text":72,"@type":64},"Merck is urged to launch MK-8527 at or near parity with generic oral PrEP in LMICs, keep the price public, and target a launch price under $40 per person per year to avoid rationing and restrictive eligibility.",{"name":74,"@type":61,"acceptedAnswer":75},"What licensing terms does the letter ask Merck to adopt?",{"text":76,"@type":64},"The letter calls for non-exclusive 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Davis  \nChairman and Chief Executive Officer Merck & Co. , Inc.  \n126 East Lincoln Avenue Rahway, NJ 07065 United States  \n(también disponible en español aquí)  \nRe: Ensuring Equitable Global Access to MK-8527 for HIV Prevention  \nDear Mr. Davis,  \nWe, the undersigned, write to you as members of the HIV community, both people affected by  \nand living with HIV, and HIV and health organisations, regarding Merck's promising once-monthly oral PrEP candidate MK-8527 , now in Phase III clinical trials.  \nMK-8527 represents a potentially transformative addition to the HIV prevention toolkit—a convenient monthly oral option that could address the adherence challenges that have limited the impact of daily oral PrEP, particularly in low-income and middle-income countries ( LMICs) where the vast majority of the 1.3 million people who acquire HIV each year reside.  \nWe are at a historic inflection point. For the first time, we are witnessing a new HIV prevention tool—long-acting injectable lenacapavir ( LEN)—being introduced in high-income countries anda handful of LMICs nearly simultaneously. We can see the interest from HIV programmes with lenacapavir receiving ten African regulatory approvals within just six months of FDA approval. This stands in stark contrast to the painful history of HIV treatment, where life-saving antiretroviral therapy transformed HIV from a death sentence to a manageable illness in wealthy countries by the mid-1990s, yet did not reach African communities at any scale until the mid-2000s due to lack of availability, high prices and intellectual property barriers. Millions of people died while waiting.  \nThe LEN acceleration demonstrates what is possible when HIV programmes, product developers, regulators, communities, activists, and global health stakeholders work together with intention and urgency. MK-8527 offers Merck the opportunity to build on this momentum and set a new standard for equitable access—one where people in LMICs can access a breakthrough prevention tool at the same time as people in high-income countries.  \nWe urge Merck to commit now—during the clinical development phase, not after regulatory approval—to a comprehensive access strategy. Specifically, we call on Merck to take the following actions:  \nPursue Multiple Regulatory Pathways  \nIn addition to filing with the US FDA, we ask that Merck simultaneously utilize the EMA’s EU-M4all process (formerly Article 58) , WHO Prequalification, and WHO's Collaborative Registration Procedure to accelerate national regulatory reviews. We urge Merck to commit  \npublicly to broad, accelerated registration of MK-8527 globally for all LMICs. In addition, we request Merck submit dossiers for regulatory approval in at least ten high-burden African countries within six months of any major regulatory approval, working proactively with national regulatory authorities to prepare dossiers in advance of efficacy results. In order to avoid regulatory barriers in India, specifically, we ask that Merck include people of Indian ethnicity in the ongoing clinical trials, so that the data becomes available at the time of registration in India, a major supplier of more affordable generics.  \nCommit to Fair, Transparent Pricing from the Outset  \nHigh launch prices for new prevention technologies create a chilling effect on programmatic ambition, leading to rationing, restrictive eligibility criteria, and perpetuating stigma around prevention tools. We have seen this pattern repeatedly: when products are priced beyond what programs can afford, they simply do not reach the people who need them.  \nWe urge Merck to commit to pricing MK-8527 at or near parity with generic oral PrEP in LMICs from the point of introduction—not years later after generic competition forces price reductions. MK-8527’s price must be public. Achieving a launch price point of less than $40 per person per year would enable programs to plan for scale rather than resort to rationing. Merck should","cbCaikrBQRjoyc1O","https://ap.wps.com/l/cbCaikrBQRjoyc1O","pdf",154788,"English","# Key requests for Merck\n## Pursue multiple regulatory pathways\n## Commit to fair, transparent pricing from the outset\n## Establish pro-access, non-exclusive licensing for all LMICs","[{\"question\":\"What is MK-8527 and what stage is it in?\",\"answer\":\"MK-8527 is a once-monthly oral PrEP candidate currently in Phase III clinical trials.\"},{\"question\":\"Why does the letter stress accelerated and broad regulatory registration?\",\"answer\":\"It argues that rapid, simultaneous registration can overcome past availability and access delays, enabling LMICs to receive prevention tools at the same time as high-income countries.\"},{\"question\":\"What pricing approach does the letter request from Merck?\",\"answer\":\"Merck is urged to launch MK-8527 at or near parity with generic oral PrEP in LMICs, keep the price public, and target a launch price under $40 per person per year to avoid rationing and restrictive eligibility.\"},{\"question\":\"What licensing terms does the letter ask Merck to adopt?\",\"answer\":\"The letter calls for non-exclusive voluntary licenses, finalized and announced before regulatory approval, that cover all LMICs without geographic restrictions and avoid clauses that prevent supply outside the licensed scope when no patents exist or in compulsory license cases.\"}]","Ensuring Equitable Global Access to MK-8527 for HIV Prevention | PDF",1790551315]