Pharmaceutical

Enrolled Participants Will Continue to Receive Study Medicine

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced a pause in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 clinical studies evaluating investigational, once-monthly, oral islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP) in people at high risk of HIV-1 infection.

At the recommendation of the ISL PrEP external data monitoring committee (eDMC), Merck is pausing enrollment for the IMPOWER 22 and IMPOWER 24 trials while the company conducts further analyses of these and other ongoing studies. Participants already enrolled in the trials will continue to receive the study medicine. Informed by the recommendations of the PrEP eDMC, Merck is implementing additional monitoring measures for study participants, including increasing the frequency of total lymphocyte and CD4+ T-cell assessments. Investigators have been informed of these actions.

"We continue to apply learnings from our HIV program as we move forward with the development of islatravir in both treatment and PrEP," said Dr. Joan Butterton, vice president, infectious diseases, Global Clinical Development, Merck Research Laboratories. "Merck remains committed to developing tools to help address unmet needs in HIV treatment and prevention to contribute to the global effort against the ongoing HIV epidemic."

About IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024)

The IMPOWER 22 clinical trial is a Phase 3, randomized, active-controlled, double-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly compared to once-daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as pre-exposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 Infection.

The IMPOWER 24 clinical trial is a Phase 3, randomized, active-controlled, double-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly as PrEP compared to once-daily FTC/TDF or emtricitabine/tenofovir alafenamide (FTC/TAF) in cisgender men and transgender women who have sex with men, and are at high risk for HIV-1 infection.

About Islatravir (MK-8591)

Islatravir (MK-8591) is Merck's investigational nucleoside reverse transcriptase translocation inhibitor under evaluation for the treatment and prevention of HIV-1.

Our Commitment to HIV

For more than 35 years, Merck has been committed to scientific research and discovery (R&D) in HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV, with the goal of reducing the growing burden of infection worldwide. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that impede progress toward ending the epidemic.

About Merck

For over 130 years, Merck, known as MSD outside 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 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 ).

Media Contacts:

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Investor Contacts:

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(908) 740-1037

Raychel Kruper
(908) 740-2107

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BetterLife To Present BETR-001 Preclinical Data at the 61ST Annual Meeting of the American College of Neuropsychopharmacology in Phoenix, Arizona

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR  OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments for mental disorders, today announced that one of its scientific collaborators, Dr. Argel Aguilar-Valles from Carleton University's Department of Neuroscience (Ottawa, Canada), will present on the anti-depressant activity of 2-bromo-LSD ("BETR-001"), the Company's lead compound, at the upcoming ACNP Conference being held December 4 to 7 at Phoenix, Arizona, USA. BETR-001 is a non-hallucinogenic Lysergic Acid Diethylamide ("LSD") derivative molecule. Dr. Aguilar-Valles will present preclinical data supporting the acute and long-term anti-depressant activity of BETR-001 monotherapy in animal models. Furthermore, the data shows that BETR-001 promotes structural neuroplasticity in brain neurons and this effect is partly mediated by the activation of 5-HT2A receptor. Dr. Ahmad Doroudian, CEO of BetterLife commented, "BETR-001 is a uniquely positioned LSD derivative with the potential to be as effective as LSD in various neuropsychiatric and neurological disorders without the burden of being hallucinogenic. Because of its non-hallucinogenic nature, BETR-001 will not have all the LSD requirements of administration in specialized clinics under special treatment protocols, the LSD controlled substance regulatory issues which impact manufacturing, distribution and patient access, and the overall associated high treatment costs for all these parameters. Additionally, BETR-001 is protected by BetterLife's composition, method-of-use, synthesis and formulation patents (issued and provisional)." He further added, "BETR-001 IND-enabling studies are being completed and we hope to file its IND and begin human trials by mid-2023."

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Pfizer Invites Public to Register for Webcast of Pfizer Near-Term Launches + High-Value Pipeline Day

Pfizer Inc. (NYSE: PFE) invites investors and the general public to access a live video webcast of its Near-Term Launches + High-Value Pipeline Day on Monday, December 12, 2022 from 1:00 p.m. EST to 6:00 p.m. EST, with an approximately 30 minute break at the midpoint. Pfizer business executives and scientific leadership will provide updates on the company's potential near-term product launches and key high-value pipeline programs, both of which are expected to be primary growth drivers for Pfizer's 2030 revenues and beyond.

To access the live webcast and presentation slides, visit our web site at www.pfizer.com/investors . Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance.

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Roivant and Pfizer Form New Vant Company Focused on Developing TL1A Drug Candidate for Inflammatory and Fibrotic Diseases

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Roivant Sciences (Nasdaq: ROIV) and Pfizer Inc. (NYSE: PFE) today announced formation of a new Vant to develop and commercialize PF-06480605 (now RVT-3101). RVT-3101 is a fully human monoclonal antibody targeting TL1A, which is currently in Phase 2b development in ulcerative colitis (UC). The Vant has the exclusive option to collaborate with Pfizer on a next-generation TL1A directed antibody which recently entered Phase 1.

RVT-3101 is a potential first-in-class agent that targets both inflammatory and fibrotic pathways by inhibiting TL1A, which has been shown to modulate the location and severity of inflammation and fibrosis by stimulating TH1 and TH17 pathways, in addition to activating fibroblasts. As such, RVT-3101 has the potential to provide greater efficacy by hitting multiple inflammatory pathways as well as fibrotic pathways.

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Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of findings from clinical trials and real-world studies at the upcoming 64 th American Society of Hematology (ASH) Annual Meeting from Dec. 10-13, 2022, in New Orleans, Louisiana and virtually. New and updated data for KEYTRUDA, Merck's anti-PD-1 therapy, as well as from the company's investigational medicines favezelimab (anti-LAG-3 antibody), zilovertamab vedotin (antibody-drug conjugate targeting receptor tyrosine kinase-like orphan receptor 1 [ROR1]), and nemtabrutinib (reversible, non-covalent Bruton's tyrosine kinase [BTK] inhibitor) will be featured in nearly 40 abstracts.

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Merck Announces First-Quarter 2023 Dividend

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Board of Directors has declared a quarterly dividend of $0.73 per share of the company's common stock for the first quarter of 2023. Payment will be made on Jan. 9, 2023, to shareholders of record at the close of business on Dec.15, 2022.

About Merck

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Arvinas Announces ARV-471 Achieves a Clinical Benefit Rate of 38% in Evaluable Patients and Continues to Show a Favorable Tolerability Profile in its Phase 2 Expansion Trial

ARV-471 continues to show activity in heavily pre-treated patients with locally advanced or metastatic ER+/HER2- breast cancer

Median progression free survival of 3.7 months in all patients and 5.7 months in patients with ESR1 mutant tumors support the initiation of two Phase 3 registrational trials

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