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KENILWORTH, N.J.–(BUSINESS WIRE) November 16, 2020 — Merck (NYSE: MRK), generally known as MSD exterior of the USA and Canada, at this time introduced a collaboration with the Invoice & Melinda Gates Basis (the muse) the place the muse is committing to offer funding to assist a pivotal Section three examine investigating a once-monthly oral pre-exposure prophylaxis (PrEP)1 choice in ladies and adolescent women at excessive danger for buying HIV-1 an infection in sub-Saharan Africa. The examine, IMPOWER 22, will consider the efficacy and security of islatravir — Merck’s novel investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) below analysis for each therapy and prevention — and is anticipated to start by early 2021. Greater than half of latest HIV infections globally happen in sub-Saharan Africa, with ladies accounting for practically 60 % of latest infections on this area.

“Our collaboration with the Invoice & Melinda Gates Basis exemplifies our shared mission to finish the worldwide HIV epidemic by means of significant improvements in HIV prevention, together with further PrEP choices,” stated Dr. Roy D. Baynes, senior vp and head of worldwide scientific growth, chief medical officer, Merck Analysis Laboratories. “Islatravir is a promising antiviral candidate with proof from ongoing scientific trials to assist its growth as a once-monthly oral PrEP agent. By this collaboration, we will additional discover the potential of islatravir as a part of our work in direction of the collective world public well being purpose of decreasing the variety of new HIV infections.”

“The world won’t be able to finish the HIV epidemic till we will successfully forestall HIV acquisition in at-risk people and populations,” stated Dr. Emilio Emini, director of the TB & HIV program, the Invoice & Melinda Gates Basis. “This collaboration will assist advance HIV science and doubtlessly supply a brand new choice to stop HIV acquisition amongst at-risk ladies, each in sub-Saharan Africa and globally.”

Per the settlement between the muse and Merck, the muse, in its position as a funder, intends to offer grant funding to the Worldwide Scientific Analysis Middle (ICRC) on the College of Washington Division of International Well being, which is collaborating with Merck on the IMPOWER 22 examine. This grant will assist ICRC’s work with skilled trial websites in sub-Saharan Africa to enroll, observe and retain the massive variety of ladies required for this analysis. Merck would be the trial sponsor, chargeable for supplying the drugs, gaining regulatory and customs approvals, and offering operational experience and sources for administration of the trial, similar to web site monitoring and information reporting. Merck might be funding the IMPOWER 22 scientific trial in the USA.

“Globally, ladies proceed to be underserved in HIV analysis and care. In 2019, ladies accounted for 48 % of latest infections, and in 2018, AIDS-related sicknesses remained the main reason for loss of life for girls throughout their reproductive years,” stated Prof. Elizabeth Anne Bukusi, MBChB, PhD, senior principal scientific analysis scientist and co-director of the Analysis Care Coaching Program on the Middle for Microbiology Analysis of The Kenya Medical Analysis Institute, and a trial investigator. “We is not going to flip the tide on HIV globally till we flip the tide on the virus in Africa, and this scientific trial seeks to assist advance this effort by means of its concentrate on ladies, particularly youthful ladies, who stay disproportionately in danger on this continent.”

About IMPOWER Scientific Trials Program

IMPOWER 22is a randomized, active-controlled, double-blind, multisite Section three examine evaluating the efficacy and security of islatravir administered orally once-monthly as PrEP in cisgender ladies who’re at excessive danger for HIV-1 an infection in sub-Saharan Africa and the USA. The lively comparator for this examine, emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), might be administered orally as soon as each day. Roughly 4,500 cisgender ladies and adolescent women, ages 16 by means of 45, might be randomized (stratified by web site and age) in a 1:1 ratio to obtain both islatravir or FTC/TDF at some point of the examine. Info on this examine might be posted shortly on

Merck additionally plans to conduct further research in HIV prevention with islatravir in once-monthly oral PrEP. These research will embrace IMPOWER 24, a world Section three scientific trial to judge islatravir as a once-monthly oral agent for PrEP at websites internationally and amongst different key populations impacted by the epidemic, together with males who’ve intercourse with males (MSM) and transgender ladies.

About Islatravir (MK-8591)

Islatravir (previously MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) at the moment being evaluated in scientific trials for the therapy of HIV-1 an infection together with different antiretrovirals, in addition to for pre-exposure prophylaxis (PrEP) of HIV-1 an infection as a single investigational agent, throughout quite a lot of formulations. In 2012, Merck licensed islatravir (4’-ethynyl-2-fluoro-2’-deoxyadenosine or EFdA) from the Yamasa Company primarily based in Choshi, Japan.

Merck’s Dedication to HIV

For greater than 30 years, Merck has been dedicated to scientific analysis and discovery in HIV, and we proceed to be pushed by the conviction that extra medical advances are nonetheless to return. Our focus is on pursuing analysis that addresses unmet medical wants and helps folks dwelling with HIV and their communities. We stay dedicated to working hand-in-hand with our companions within the world HIV neighborhood to deal with the complicated challenges that hinder continued progress.

In regards to the Invoice & Melinda Gates Basis

Guided by the idea that each life has equal worth, the Invoice & Melinda Gates Basis works to assist all folks lead wholesome, productive lives. In growing international locations, it focuses on enhancing folks’s well being and giving them the prospect to carry themselves out of starvation and excessive poverty. In the USA, it seeks to make sure that all folks—particularly these with the fewest sources—have entry to the alternatives they want to reach college and life. Based mostly in Seattle, Washington, the muse is led by CEO Mark Suzman, below the route of Invoice and Melinda Gates and Warren Buffett.

About Merck

For greater than 125 years, Merck, generally known as MSD exterior of the USA and Canada, has been inventing for all times, bringing ahead medicines and vaccines for lots of the world’s most difficult ailments in pursuit of our mission to save lots of and enhance lives. We exhibit our dedication to sufferers and inhabitants well being by growing entry to well being care by means of far-reaching insurance policies, applications and partnerships. Immediately, Merck continues to be on the forefront of analysis to stop and deal with ailments that threaten folks and animals – together with most cancers, infectious ailments similar to HIV and Ebola, and rising animal ailments – as we aspire to be the premier research-intensive biopharmaceutical firm on the earth. For extra data, go to  and join with us on Twitter, Fb, Instagram, YouTube and LinkedIn.

Ahead-Trying Assertion of Merck & Co., Inc., Kenilworth, N.J., USA

This information launch of Merck & Co., Inc., Kenilworth, N.J., USA (the “firm”) contains “forward-looking statements” throughout the which means of the protected harbor provisions of the U.S. Personal Securities Litigation Reform Act of 1995. These statements are primarily based upon the present beliefs and expectations of the corporate’s administration and are topic to vital dangers and uncertainties. There might be no ensures with respect to pipeline merchandise that the merchandise will obtain the mandatory regulatory approvals or that they may show to be commercially profitable. If underlying assumptions show inaccurate or dangers or uncertainties materialize, precise outcomes could differ materially from these set forth within the forward-looking statements.

Dangers and uncertainties embrace however are usually not restricted to, common trade circumstances and competitors; common financial elements, together with rate of interest and forex alternate price fluctuations; the influence of the worldwide outbreak of novel coronavirus illness (COVID-19); the influence of pharmaceutical trade regulation and well being care laws in the USA and internationally; world tendencies towards well being care price containment; technological advances, new merchandise and patents attained by opponents; challenges inherent in new product growth, together with acquiring regulatory approval; the corporate’s capability to precisely predict future market circumstances; manufacturing difficulties or delays; monetary instability of worldwide economies and sovereign danger; dependence on the effectiveness of the corporate’s patents and different protections for revolutionary merchandise; and the publicity to litigation, together with patent litigation, and/or regulatory actions.

The corporate undertakes no obligation to publicly replace any forward-looking assertion, whether or not on account of new data, future occasions or in any other case. Extra elements that would trigger outcomes to vary materially from these described within the forward-looking statements might be discovered within the firm’s 2019 Annual Report on Type 10-Ok and the corporate’s different filings with the Securities and Trade Fee (SEC) accessible on the SEC’s Web web site ().

1 PrEP is a method for individuals who should not have HIV, who’re thought-about high-risk for buying HIV, to stop the an infection. Presently, the one accessible/permitted dosing choice is to take a capsule each day. PrEP has been proven to successfully cut back the danger of HIV an infection from intercourse when taken each day, however is much less efficient if it isn’t taken constantly. (Supply: )

Supply: Merck
 

Posted: November 2020