Pharmaceutical

Merck known as MSD outside Canada and the United States announced today that it has entered into a Supply Agreement with the Government of Canada for up to 1 million patient courses of molnupiravir, its investigational oral antiviral medicine for the treatment of COVID-19. This investigational medicine is being developed by Merck in collaboration with Ridgeback Biotherapeutics. Through this agreement, the Government ...

 Merck (NYSE: MRK), known as MSD outside Canada and the United States announced today that it has entered into a Supply Agreement with the Government of Canada for up to 1 million patient courses of molnupiravir, its investigational oral antiviral medicine for the treatment of COVID-19. This investigational medicine is being developed by Merck in collaboration with Ridgeback Biotherapeutics.

Through this agreement, the Government of Canada has secured access in 2022 to 500,000 patient courses, with options for up to 500,000 more, pending Health Canada approval. This new agreement is part of Merck's commitment to make this investigational medicine widely available globally, if approved for use by regulatory agencies.

"We applaud the leadership of the federal government who has worked tirelessly to bolster pandemic preparedness against COVID-19. While vaccines continue to play a primary role in helping prevent the spread and seriousness of cases, more treatment options are urgently needed to help reduce the burden of COVID-19," said Marwan Akar , President and Managing Director of Merck Canada.

In November, Merck Canada filed the final wave of the molnupiravir rolling submission to Health Canada, which will decide on the therapy's approval only when all necessary evidence has been reviewed.

About Merck's Global Efforts to Accelerate Access to Molnupiravir Following Regulatory Authorizations or Approvals

Merck is committed to providing timely access to molnupiravir globally through our comprehensive supply and access approach, which includes investing at risk to produce millions of courses of therapy; tiered pricing based on the ability of governments to finance health care; entering into supply agreements with governments; and granting voluntary licenses to generic manufacturers and to the Medicines Patent Pool to make generic molnupiravir available in low- and middle-income countries following local regulatory authorizations or approvals.

Supply: In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million courses to be produced in 2022.

Supply agreements: Earlier this year, Merck entered into a procurement agreement with the U.S. Government under which the company will supply approximately 3.1 million courses of molnupiravir to the U.S. Government, upon Emergency Use Authorization (EUA) or approval from the U.S. FDA. Additionally, Merck has entered into supply and advance purchase agreements for molnupiravir with governments worldwide and is currently in discussions with additional governments. Merck plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries' relative ability to finance their health response to the pandemic.

Voluntary licenses: As part of its commitment to widespread global access, Merck previously announced that it has entered into a licensing agreement with the Medicines Patent Pool to increase broad access for molnupiravir in low- and middle-income countries. Additionally, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.

Merck continues to discuss additional measures and collaborations to accelerate broad, global access to molnupiravir.

About Ridgeback Biotherapeutics

Headquartered in Miami, Florida , Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets Ebanga TM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. The team at Ridgeback is dedicated to developing life-saving and life-changing solutions for patients and diseases that need champions as well as providing global access to these medicines. In line with Ridgeback's mission for equitable global access, all Ridgeback services and treatment for Ebola patients in Africa are delivered free of charge.

About Merck

For over 130 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 about our operations in Canada , visit www.merck.ca and connect with us on YouTube and Twitter @MerckCanada.

Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ , 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 candidates that the candidates 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 2020 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 ).

SOURCE Merck Canada Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/December2021/03/c0422.html

News Provided by Canada Newswire 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.

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

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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."

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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."

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