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RAHWAY, N.J. - Merck (NYSE:MRK), a pharmaceutical giant with a market capitalization of $210 billion and currently identified as undervalued according to InvestingPro analysis, announced Monday the initiation of its EXPrESSIVE Phase 3 clinical trials to evaluate MK-8527, an investigational once-monthly oral medication for HIV prevention.
The program consists of two major trials: EXPrESSIVE-11, which will evaluate the drug among people with higher likelihood of HIV-1 exposure across 16 countries starting in August, and EXPrESSIVE-10, which will focus on women and adolescent girls in sub-Saharan Africa and begin enrollment in the coming months.
The EXPrESSIVE-10 trial is being conducted in collaboration with the Gates Foundation, which will provide funding support for 31 clinical research sites in Kenya, South Africa, and Uganda. Merck will serve as the trial sponsor.
The decision to advance to Phase 3 trials follows positive Phase 2 results presented at the International AIDS Society Conference in Kigali, Rwanda. The Phase 2 study of 350 participants showed similar adverse event rates between MK-8527 and placebo groups, with no clinically meaningful changes in laboratory tests. This development adds to Merck’s robust pharmaceutical portfolio, which generated $63.9 billion in revenue over the last twelve months with an impressive 77% gross profit margin, according to InvestingPro data.
"According to UNAIDS, 1.3 million people acquired HIV in 2023, highlighting the continued need for new PrEP options," said Dr. Eliav Barr, senior vice president and chief medical officer at Merck Research Laboratories, in the press release.
Trevor Mundel, president of global health at the Gates Foundation, noted that only 18% of global PrEP need is currently being met, emphasizing the potential importance of longer-acting prevention options.
The EXPrESSIVE-11 trial will enroll 4,390 participants across 16 countries, while EXPrESSIVE-10 will include 4,580 women aged 16 to 30 in three African nations. Both studies will compare once-monthly oral MK-8527 to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), measuring efficacy by the rate of HIV-1 infections.
MK-8527 works by inhibiting reverse transcriptase through multiple mechanisms, including inhibition of translocation and delayed chain termination, according to the company statement. With a "GREAT" financial health score and multiple positive indicators identified by InvestingPro, including strong cash flow coverage and consistent dividend payments, Merck continues to demonstrate its leadership in pharmaceutical innovation. Discover 8 additional exclusive ProTips and comprehensive analysis in the Pro Research Report.
In other recent news, Merck has confirmed its acquisition of Verona Pharma in a deal valued at approximately $10 billion, representing a 23% premium over Verona’s last closing price. This acquisition is expected to enhance Merck’s portfolio in the respiratory disease treatment space, particularly with Verona’s novel PDE3/4 nebulizer treatment for COPD, Ohtuvayre. Analysts from UBS have reiterated a Buy rating for Merck, highlighting the acquisition as a positive move that aligns with industry precedents and addresses past criticisms of Merck’s business development activities. Meanwhile, Cantor Fitzgerald has maintained a Neutral rating, projecting that the deal could enhance Merck’s top-line growth and become accretive to earnings by 2027.
Additionally, the U.S. Food and Drug Administration has accepted Merck’s New Drug Application for a two-drug HIV treatment, with a target action date set for April 28, 2026. This investigational regimen could become the first FDA-approved two-drug treatment without an integrase inhibitor, based on Phase 3 clinical trials showing non-inferior efficacy to current therapies. On the analyst front, Jefferies downgraded Verona Pharma to Hold following the acquisition news, noting the strong launch potential for Ohtuvayre. Merck has expressed an openness to further acquisitions to offset challenges like the upcoming Keytruda patent cliff in 2028.
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