Pharmaceutical

Merck (NYSE: MRK), known as MSD outside the United States and Canada, will hold its second-quarter 2022 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. ET on Thursday, July 28. During the call, company executives will provide an overview of Merck's performance for the quarter and outlook.

Investors, journalists and the general public may access a live audio webcast of the call via this weblink . A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com .

Participants may join the call by dialing 877-692-8955 (USA Toll-Free) or 234-720-6979. If you are calling from other countries, visit this weblink . All dial-in participants can use the access code 1857604. Journalists who wish to ask questions are requested to contact a member of Merck's Media Relations team.

About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. 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., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, 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. 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 Annual Report on Form 10-K for the year ended December 31, 2021 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

Media:
Johanna Herrmann
(617) 216-6029

Melissa Moody
(215) 407-3536

Investors:
Peter Dannenbaum
(908) 740-1037

Steven Graziano
(908) 740-6582

News Provided by Business Wire via QuoteMedia

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OTC:BCTXF

BriaCell Announces Grant to Investigator Dr. Saveri Bhattacharya at Sidney Kimmel Cancer Center – Jefferson Health

Highlights:

  • Grant awarded to Dr. Saveri Bhattacharya, Principal Investigator of the Phase I/IIa combination study of Bria-IMT™ with KEYTRUDA® (by Merck) in advanced breast cancer at Thomas Jefferson University.
  • Merck to provide KEYTRUDA® for use in the combination study.
  • The Investigator Grant validates and will build on the encouraging preliminary data from BriaCell’s combination study of Bria-IMT™ with KEYTRUDA® (Link).

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, today announced that Dr. Saveri Bhattacharya, a board-certified medical oncologist and recognized expert in breast cancer treatment at the Sidney Kimmel Cancer Center – Jefferson Health in Philadelphia, PA, has been selected to receive support from the Merck Investigator Studies Program (“MISP”). The Investigator Grant is a highly coveted award granted by Merck & Co., Inc. (“Merck”) (NYSE: MRK) to leading investigators with highly innovative clinical studies.

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Merck Announces Q4 and Full-Year 2019 Financial Results

Merck (NYSE:MRK) reported quarterly worldwide sales at US$11.9 billion in Q4 in its financial results for the fourth quarter of 2019 and its full fiscal 2019 year.

As quoted in the press release:

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OTC:BCTXF

BriaCell’s Clinical Data Accepted to be Presented at the Annual Symposium of Society of Surgical Oncology 2020 in Boston

Safety and early efficacy data to be presented from clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors in advanced breast cancer:

  • Bria-IMT™ in combination with pembrolizumab (KEYTRUDA®; by Merck & Co., Inc.);
  • Bria-IMT™ in combination with INCMGA00012 (by Incyte Corporation).

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, is pleased to announce that the data of its clinical studies with its lead product candidate, Bria-IMT™, will be presented the at the Annual Symposium of Society of Surgical Oncology (SSO) 2020 – International Conference on Surgical Cancer Care taking place March 25-28 in Boston, MA.

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OTC:BCTXF

BriaCell Invited to Present at Mount Sinai’s Frontiers in Academic Pathology Symposium at The New York Academy of Medicine

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, announced today that it will present at the “Frontiers in Academic Pathology” symposium, hosted by the Icahn School of Medicine at Mount Sinai, to be held on Friday, January 31, 2020 at The New York Academy of Medicine, 1216 Fifth Avenue in New York. The symposium focus will include molecular biomarkers, experimental diagnostics and liquid biopsies, all of which factor heavily in the development of BriaCell’s companion diagnostics under development, including BriaCell’s HLA-matching hypothesis and recently-announced Grade I/II biomarkers.

Dr. Bill Williams, BriaCell’s President & CEO, will be presenting BriaCell’s unique and effective immunotherapy approach at the conference, focusing on the biomarkers noted to date in determining clinical benefit in advanced stage breast cancer.

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BriaCell Provides Update on Remarkable Responder

BriaCell Provides Update on Remarkable Responder

Highlights:

  • Patient initially identified September 19, 2019 as a Remarkable Responder;
  • Patient has continued to experience a highly remarkable reduction in tumors that had metastasized to areas outside of the breasts;
  • A metastasized tumor behind the left eye orbital region, which had pushed the eye forward from the skull, has now completely disappeared;
  • Prior to BriaCell’s treatment, patient had failed prior regimens with 16 agents (13 chemotherapy and 3 hormonal);
  • Patient remains on BriaCell’s treatment.

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, is pleased to provide an update on the previously-announced (Link) top responder (“Remarkable Responder”) in the combination study of its lead candidate, Bria-IMT™, with Incyte’s INCMGA00012, a PD-1 inhibitor.

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Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE®, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis

  • Data from the Phase 3 SPIRIT program showed MYFEMBREE reduced menstrual pain and non-menstrual pelvic pain in premenopausal women with endometriosis, and a loss of mean bone mineral density of less than 1% from baseline through one year of treatment
  • Myovant and Pfizer will continue to jointly commercialize MYFEMBREE, with product available immediately
  • Myovant to host conference call and webcast on Monday, August 8, 2022, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time

Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE ® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months. The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which were published in The Lancet and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. MYFEMBREE also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant and Pfizer will continue to jointly commercialize MYFEMBREE in the U.S. and product is available immediately.

"Endometriosis is a painful, chronic disease with limited therapies to manage symptoms," said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. "The new MYFEMBREE indication helps advance our mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis."

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Jamieson Wellness Inc. Reports Second Quarter 2022 Financial Results

Company Increases Fiscal 2022 Guidance and Raises Second Quarter Dividend

Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX: JWEL) today reported financial results for its second quarter ended June 30, 2022. All amounts are expressed in Canadian dollars. Certain metrics, including those expressed on an adjusted basis, are non-IFRS and other financial measures. See "Non-IFRS and Other Financial Measures" below.

News Provided by Business Wire via QuoteMedia

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LYNPARZA® Approved in the EU as Adjuvant Treatment for Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA 1/2 mutations (g BRCA m), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

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Merck and Eisai Provide Update on Phase 3 LEAP-002 Trial Evaluating KEYTRUDA® Plus LENVIMA® Versus LENVIMA Monotherapy in Patients With Unresectable Hepatocellular Carcinoma

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the Phase 3 LEAP-002 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus LENVIMA monotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). There were trends toward improvement in OS and PFS for patients who received KEYTRUDA plus LENVIMA versus LENVIMA monotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan. The median OS of the LENVIMA monotherapy arm in LEAP-002 was longer than that observed in previously reported clinical trials evaluating LENVIMA monotherapy in uHCC. The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination. Merck and Eisai plan to present these data at an upcoming medical conference.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220803005211/en/

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Merck Provides Update on Phase 3 KEYNOTE-921 Trial Evaluating KEYTRUDA® Plus Chemotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-921 trial evaluating KEYTRUDA in combination with chemotherapy (docetaxel) compared to chemotherapy alone did not meet its dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In the study, there were modest trends toward an improvement in both OS and rPFS for patients who received KEYTRUDA plus chemotherapy compared with chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting.

"Results from this study serve as an important reminder that metastatic prostate cancer remains very difficult to treat, and more research is needed. We will continue to advance our clinical development program to evaluate KEYTRUDA-based combinations and novel candidates for patients with this disease," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "We are grateful to the patients and investigators for their participation in this study."

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PFIZER REPORTS SECOND-QUARTER 2022 RESULTS

  • Second-Quarter 2022 Revenues of $27.7 Billion, Reflecting 53% Operational Growth, Driven Primarily by Strong Contributions from Paxlovid and Comirnaty (1)
  • Second-Quarter 2022 Reported Diluted EPS (2) of $1.73, Reflecting 77% Growth Over Second-Quarter 2021
  • Second-Quarter 2022 Adjusted Diluted EPS (3) of $2.04, Reflecting 92% Growth Over Second-Quarter 2021; Excluding Foreign Exchange Impacts, Adjusted Diluted EPS (3) Grew 100%
  • Raises Full-Year 2022 Financial Guidance (4) for Revenues and Adjusted Diluted EPS (3) by $2 Billion and $0.24, Respectively, on an Operational Basis (Which Excludes the Impact of Foreign Exchange)
    • Including Foreign Exchange Impacts, Pfizer Reaffirms Revenue Guidance of $98.0 to $102.0 Billion and Raises Lower End of Adjusted Diluted EPS (3) Guidance by $0.05 to a Range of $6.30 to $6.45
    • Reaffirms 2022 Revenue Guidance for Comirnaty (1) and Paxlovid of ~$32 Billion and ~$22 Billion, Respectively, Despite Unfavorable Impacts from Foreign Exchange
  • Pipeline Programs That Have Achieved Milestones Since Previous Earnings Release Include Bivalent mRNA COVID-19 Vaccine, Enhanced mRNA COVID-19 Vaccine, Paxlovid, modRNA Influenza Vaccine, Once-Daily Oral GLP-1 Receptor Agonist and Anti-Interferon-β

Pfizer Inc. (NYSE: PFE) reported strong financial results for second-quarter 2022 and updated certain components of 2022 financial guidance (4) . Pfizer reaffirmed its previous 2022 revenue guidance, despite unfavorable impacts from foreign exchange, while reaffirming its revenue guidance for Comirnaty (1) , the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, and for Paxlovid, its oral COVID-19 treatment.

The second-quarter 2022 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer's R&D pipeline can be found at www.pfizer.com .

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