Merck to Present New Data from Studies of Investigational HIV Therapy Doravirine, Including Pivotal DRIVE-FORWARD Trial, at AIDS 2018

//Merck to Present New Data from Studies of Investigational HIV Therapy Doravirine, Including Pivotal DRIVE-FORWARD Trial, at AIDS 2018

Merck to Present New Data from Studies of Investigational HIV Therapy Doravirine, Including Pivotal DRIVE-FORWARD Trial, at AIDS 2018

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from the company are scheduled to be presented at the 22 nd International AIDS Conference (AIDS 2018) taking place July 23-27 in Amsterdam. Presentations include Week 96 data from the Phase 3 DRIVE-FORWARD clinical trial for doravirine (DOR) and additional analyses for DOR and investigational therapy MK-8591. DOR is a non-nucleoside reverse transcriptase inhibitor (NNRTI) under investigation as a single tablet for use in combination with other antiretroviral (ARV) agents and as a fixed-dose combination with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history (treatment-naïve). MK-8591 is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated in clinical trials for the treatment of HIV infection.

“While enormous progress has been made in the fight against HIV/AIDS, continued scientific innovation is needed given the unmet need that continues to exist in HIV,” said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, global clinical development, Merck Research Laboratories. “Merck looks forward to presenting these new data from our HIV pipeline at AIDS 2018.”

Presentations include a late-breaking poster of the Week 96 data from the pivotal Phase 3 DRIVE-FORWARD clinical trial evaluating the safety and efficacy of once-daily DOR compared to once-daily ritonavir-boosted darunavir (DRV+r), each administered with either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC), in treatment-naïve adults with HIV-1 infection. In addition, analyses of the resistance profiles of DOR and MK-8591 will be presented.

Data to be presented include:

Doravirine Versus Ritonavir-Boosted Darunavir: 96-Week Results of the Randomized, Double-Blind, Phase 3 DRIVE-FORWARD Noninferiority Trial. Abstract LBPEB017. K. Squires. Late-breaking Poster Exhibition: Wednesday, July 25, 12:30-14:30 CET, Poster Exhibition Area, Hall 1Understanding the Resistance Profile of the HIV-1 NNRTI Doravirine in Combination with the Novel NRTTI MK-8591. Abstract THPEB068. D. Hazuda. Poster Exhibition: Thursday, July 26, 12:30-14:30 CET, Poster Exhibition Area, Hall 1Characterization of Doravirine-Selected Resistance Patterns from Participants in Treatment-Naïve Phase 3 Clinical Trials. Abstract THPDB0101. M. Lai. Poster Discussion: Thursday, July 26, 13:00-14:00 CET, Emerald Room

Earlier this year, the U.S. Food and Drug Administration (FDA) accepted for review New Drug Applications for DOR and DOR/3TC/TDF for the treatment of HIV-1 infection in treatment-naïve adults. The FDA has set a target action date of October 23, 2018 for both applications.

About MerckFor more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on TwitterFacebookInstagramYouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USAThis news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2017 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ).

CONTACT: Merck

Media:

Pamela Eisele, 267-305-3558

or

Carmen de Gourville, 267-305-4195

Source: https://www.thedailytimes.com/business/merck-to-present-new-data-from-studies-of-investigational-hiv/article_a51a56bb-5dce-5d01-aab3-1ef6c1cd3a36.html