Pharmaceutical

Merck known as MSD outside the United States and Canada, today announced it has entered into an agreement with the United States Government to support the development, manufacture and initial distribution of an investigational biological therapeutic upon approval or Emergency Use Authorization from the U.S. Food and Drug Administration . Merck acquired MK-7110 through the acquisition of OncoImmune, a privately held, ...

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced it has entered into an agreement with the United States Government to support the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Merck acquired MK-7110 through the acquisition of OncoImmune, a privately held, clinical-stage biopharmaceutical company.

"Building upon the promising clinical findings to date for MK-7110, Merck is pleased to be collaborating with the U.S. Government to advance the manufacture and distribution of this candidate for patients with serious COVID-19 disease," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.

Under the agreement, Merck will receive up to approximately $356 million for manufacturing and supply of approximately 60,000-100,000 doses of MK-7110 to the U.S. Government through June 30, 2021 to meet the government's Operation Warp Speed goals. This approach is intended to expedite delivery of MK-7110 to the American people as quickly as possible, following potential EUA or FDA approval. Merck is also investing to expand its manufacturing capacity to increase supply of MK-7110.

In September 2020, OncoImmune reported topline findings from an interim efficacy analysis of a Phase 3 study evaluating MK-7110 for the treatment of patients with severe and critical COVID-19. An interim analysis of data from 203 participants (75% of the planned enrollment) indicated that hospitalized patients with COVID-19 treated with a single dose of MK-7110 showed a 60% higher probability of improvement in clinical status compared to placebo, as defined by the protocol. The risk of death or respiratory failure was reduced by more than 50%. The study is ongoing.

About SAC-COVID Phase 3 Trial

The SAC-COVID Phase 3 clinical trial ( NCT04317040 ) is a randomized, double blind, placebo-controlled trial designed to evaluate the safety and efficacy of CD24Fc/MK-7110 in hospitalized patients with COVID-19 requiring oxygen support, including those requiring supplemental oxygen, high flow oxygen, and mechanical ventilation. Participants were randomly assigned into two arms receiving either standard of care plus a single dose of MK-7110 via an intravenous infusion on Day 1 or standard of care plus placebo on Day 1. The multi-center trial was initiated in April 2020 and had enrolled 243 patients when the trial was closed due to full enrollment in September 2020.

About Operation Warp Speed

OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

About MK-7110 (CD24Fc)

MK-7110 is a potentially first-in-class recombinant fusion protein that targets the innate immune system. In addition to the Phase 3 clinical trial for COVID-19 patients, MK-7110 has been studied for safety in healthy volunteers and in Phase 2 clinical trials for the prevention of graft versus host disease (GVHD) following hematopoietic stem cell transplantation in patients with leukemia. A pivotal Phase 3 clinical trial (NCT04095858) for prophylaxis of GVHD has been initiated nationwide.

About Merck's Ongoing Commitment to COVID-19

Merck has been committed to developing an effective response to COVID-19 since the early stage of the pandemic and is exploring multiple paths to advance the understanding of SARS-CoV-2 infection. In addition to the development of MK-7110, in collaboration with Ridgeback Biotherapeutics Merck is evaluating molnupiravir, an investigational orally available anti-viral agent being evaluated in two Phase 2/3 trials for the treatment of patients with COVID-19 in both the outpatient and hospital settings. The company is also conducting clinical trials to evaluate two SARS-CoV-2/COVID-19 vaccine candidates: V590, being developed through a collaboration with IAVI, which utilizes a recombinant vesicular stomatitis vector, and V591 which uses a measles virus vector-based platform.

About Merck

For more than 125 years, Merck, 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 in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This 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 the global outbreak of novel coronavirus disease (COVID-19); 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 2019 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 ).

Media:
Patrick Ryan, (973) 275-7075
Ian R. McConnell, (973) 901-5722

Investor:
Peter Dannenbaum, (908) 740-1037
Michael DeCarbo (908) 740-1807

News Provided by Business Wire via QuoteMedia

BetterLife Receives FDA Response On Its Pre-IND Application For Major Depressive Disorder Treatment With BETR-001

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of 2nd-generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, is pleased to announce it has received a written response from the U.S. Food and Drug Administration (FDA) to its pre-investigational new drug (pre-IND) application for the treatment of MDD with BETR-001. BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD) and is currently undergoing IND-enabling non-clinical studies and GMP manufacturing for clinical trials. The FDA response is in general agreement with the Company's planned program for the development of BETR-001 and provided guidance regarding the BETR-001 IND-enabling non-clinical toxicology studies, its manufacturing strategy, and initial proposed clinical trial parameters.

"We are very pleased with the outcome of the BETR-001 pre-IND meeting with the FDA. The response from the FDA confirms that our current program will support the filing of BETR-001's IND application and initiation of human clinical trials by the third quarter of this year. Being a non-hallucinogenic derivative of LSD makes BETR-001 a unique molecule with therapeutic potential for the treatment of debilitating psychiatric and neurological disorders with high unmet need, such as major depressive disorders and cluster headaches. Our team is fully dedicated to start the human clinical trials in the United States by early second half of this year," said BetterLife's Chief Executive Officer, Dr. Ahmad Doroudian.

Keep reading... Show less

Results From Pivotal Phase 3 KEYNOTE-775/Study 309 Trial of KEYTRUDA® Plus LENVIMA® in Advanced Endometrial Carcinoma Published in the New England Journal of Medicine

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced the publication of results from the Phase 3 KEYNOTE-775/Study 309 trial in the January 19, 2022 edition of the New England Journal of Medicine . The pivotal study evaluated the combination of KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus chemotherapy (treatment of physician's choice of doxorubicin or paclitaxel) for patients with advanced endometrial carcinoma following at least one prior platinum-based regimen in any setting.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220120005102/en/

Keep reading... Show less

Frank Clyburn to Leave Merck

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Frank Clyburn, executive vice president and president, Human Health, will leave Merck on Feb. 1, 2022, to assume a leadership opportunity with another company. Leadership of Human Health following Frank's departure will be announced in the coming weeks.

"I am extremely appreciative of Frank's significant contributions to our company during his fourteen years with Merck. Frank has been a key catalyst for value creation, an incredible business strategist, a dedicated people leader and a fierce advocate for patients everywhere," said Robert M. Davis, chief executive officer and president, Merck. "Frank's strategic and operational excellence helped establish Merck as a global leader in oncology. Our human health business has delivered strong and sustainable growth under Frank's leadership, and we are well-positioned to continue this momentum with the strong human health team we have in place."

Keep reading... Show less

Merck's KEYTRUDA® Significantly Improved Overall Survival Versus Placebo in Certain Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib

First Presentation of OS Data From Phase 3 KEYNOTE-394 Trial at ASCO GI 2022

KEYNOTE-394 Is One of Seven Clinical Trials in Merck's Global Development Program in HCC

Keep reading... Show less

Merck Animal Health's Third Veterinarian Wellbeing Study Reveals Increased Health Challenges and Psychological Distress Among Veterinarians

- Merck Animal Health, known as MSD Animal Health outside the United States and Canada a division of Merck & Co., Inc., Kenilworth, N.J. USA (NYSE:MRK), today released findings of its comprehensive study conducted in collaboration with the American Veterinary Medical Association (AVMA) examining the wellbeing and mental health of U.S. veterinarians. Conducted in the fall of 2021, the wide-ranging Veterinary Wellbeing Study is the third survey since 2017 and the first since the COVID-19 pandemic began, with a goal to examine and bring critical awareness to the challenges impacting the veterinary profession, while highlighting the impact that the pandemic has on practitioners and staff. For the first time, the study includes responses from veterinary technicians and support staff and their perspectives on the challenges they are currently facing in work.

Keep reading... Show less

BetterLife Obtains Positive In Vivo Oral Bioavailability, Food Effect and Pharmacokinetics Data for BETR-001

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR  OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of 2 nd -generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, is pleased to announce it has obtained positive results from an in vivo oral bioavailability and food-effect pharmacokinetic (PK) study on BETR-001 in beagle dogs. BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD). Previous published studies have not included any data on PK for BETR-001. It was also unknown if presence of food would affect the bioavailability of orally administered BETR-001. The current study conducted by contract research organization, Nucro-Technics (Scarborough, ON, Canada), demonstrated the following key results after a single dose of oral BETR-001 (capsule) administered to beagle dogs:

  • No significant difference was observed in bioavailability and total exposure of BETR-001 in PK profile of fed versus fasted beagle dogs.
  • Oral bioavailability (%F), defined as the fraction of oral administered drug that reaches systemic circulation, was calculated to be 61% and 63% for fasted and fed states, respectively (no significant difference).
  • The maximum systemic concentration (C max ) of BETR-001 after a single oral dose was reached at 0.5 hr (T max ), suggesting a quick uptake of the drug into the systemic circulation. The drug was detectable in systemic circulation eight hours post oral dose with an elimination rate constant (K el ) of 0.4 per hour, pointing to the fraction of drug eliminated per unit of time.

The findings demonstrate that oral administration of a single dose of BETR-001 can reach the therapeutic range in the systemic circulation. The PK elimination constant (K el ) of 0.4 per hour for BETR-001 indicates a low probability of toxicity as a result of drug accumulation in the systemic circulation.
"We are very pleased with the results of the first oral PK study for BETR-001 drug manufactured by BetterLife's patented synthesis and formulation process. Although 2-bromo-LSD has been tested in rodents and human studies in the past, this is the first study to characterize its PK profile in vivo", stated BetterLife's Chief Executive Officer, Dr. Ahmad Doroudian. He added, "These data, together with the ongoing IND-enabling nonclinical toxicology studies, will support the filing of BETR-001's IND application with the FDA and initiation of human clinical trials in H2 2022."

Keep reading... Show less

Latest Press Releases

Related News

×