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Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
Merck (NYSE: MRK) has announced the discontinuation of MK-7110's development for COVID-19 treatment. Acquired through OncoImmune in December 2020, the drug required more data than previously expected, which would delay its availability until 2022. Consequently, Merck will redirect resources towards enhancing molnupiravir, an oral outpatient medicine, and increasing production of Johnson & Johnson's COVID-19 vaccine. This decision aligns with Merck's commitment to prioritize impactful efforts during the pandemic, as stated by Dr. Roy Baynes, senior vice president at Merck Research Laboratories.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced updates on molnupiravir, an investigational COVID-19 antiviral. Following positive interim data from the Phase 2 dose-finding trials, Merck will advance molnupiravir to the Phase 3 stage in outpatients with COVID-19, focusing on an 800 mg dosage. However, the drug's Phase 2 MOVe-IN trial for hospitalized patients was halted due to insufficient evidence of clinical benefit. Final data from the MOVe-OUT Phase 3 trial is expected by September/October 2021, with potential Emergency Use Authorization anticipated later in the year.
Merck (NYSE: MRK) announced its 20th community-based grant under the Safer Childbirth Cities initiative, focusing on improving maternal health outcomes for Black women in Austin, TX. The funding supports the Maternal Health Equity Collaborative (MHEC) to address racial inequities and enhance access to quality healthcare. The initiative aligns with Black Maternal Health Week (April 11-17, 2021), spotlighting systemic racism's impact on maternal mortality rates. Merck for Mothers pledges $500 million to combat these disparities, emphasizing local solutions.
Organon Finance 1 LLC, a Merck subsidiary, has priced an offering of €1.25 billion in euro senior secured notes and $4.1 billion in U.S. dollar senior secured notes, alongside $2 billion in senior unsecured notes. This move supports the spinoff of Organon & Co. and aims to repay intercompany loans and cover spinoff-related expenses. The notes will close on April 22, 2021, and will be guaranteed by Organon’s subsidiaries post-spinoff. The offering will cater to qualified institutional buyers and non-U.S. investors, complying with U.S. and EU regulations.
Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-564 trial for KEYTRUDA, an anti-PD-1 therapy, has met its primary endpoint of disease-free survival (DFS) in patients with renal cell carcinoma (RCC) following nephrectomy. An interim analysis showed a statistically significant improvement in DFS compared to placebo. The trial will continue to assess overall survival, a key secondary endpoint. The safety profile of KEYTRUDA remained consistent with previous studies. Results will be presented at a medical meeting and submitted for regulatory review.
Merck (NYSE: MRK) announced that Organon Finance 1 LLC plans to offer euro-denominated senior secured notes due 2028 and U.S. dollar-denominated senior secured and unsecured notes due 2028 and 2031, respectively. The proceeds will be used to repay intercompany loans and cover spinoff expenses from Merck to Organon & Co. Notes offerings will be subject to market conditions and held in escrow until spinoff conditions are met. The spinoff will form Organon, focusing on women's healthcare with a portfolio of over 60 medicines, strong cash flows, and around 10,000 employees.
Merck (NYSE: MRK) has successfully completed its cash tender offer for all outstanding shares of Pandion Therapeutics at $60 per share. Approximately 27.77 million shares, or 88.6% of Pandion's stock, were tendered. Following the tender offer, a merger was completed, making Pandion a wholly-owned subsidiary of Merck. Consequently, Pandion's stock will no longer be traded on Nasdaq. This acquisition aligns with Merck's long-term strategy to enhance its biopharmaceutical portfolio, particularly in addressing challenging diseases.
Merck (NYSE: MRK) announced a definitive agreement for Organon to acquire Alydia Health, a company focused on preventing maternal morbidity and mortality from postpartum hemorrhage. The deal is valued up to $240 million, comprising $215 million upfront and a $25 million contingent payment. This acquisition aims to enhance Organon's strategy in women’s health and expand the market reach of Alydia’s Jada System. The transaction is expected to complete after the planned spinoff of Organon from Merck, anticipated in late Q2 2021.
Merck (NYSE: MRK) received a positive opinion from the CHMP of the EMA to update the European label for KEYTRUDA, its anti-PD-1 therapy. This update incorporates data from KEYNOTE-361, a Phase 3 trial evaluating KEYTRUDA for advanced or metastatic urothelial carcinoma. Although KEYNOTE-361 missed its primary endpoints for progression-free and overall survival, the CHMP affirmed a favorable benefit-risk profile, allowing healthcare providers to better assess patient treatment options.
Merck (NYSE: MRK) received a Complete Response Letter (CRL) from the FDA regarding the supplemental Biologics License Application for KEYTRUDA, intended for high-risk early-stage triple-negative breast cancer treatment. The application, based on data from the KEYNOTE-522 trial, was deferred by the FDA's advisory committee pending additional data. The next interim analysis is slated for Q3 2021. This CRL does not affect existing approvals for KEYTRUDA, which includes treatment for locally recurrent or metastatic TNBC with PD-L1 expression.