Initial results from the Phase II KEYNOTE-799 trial evaluating Keytruda plus concurrent chemoradiation therapy demonstrated an objective response rate of 67.0 percent in Cohort A (squamous and nonsquamous non-small cell lung cancer patients who received paclitaxel plus carboplatin) and 56.6 percent in Cohort B (nonsquamous NSCLC patients who received cisplatin plus pemetrexed) in untreated patients with unresectable, locally advanced stage III NSCLC. Executing a spin-off or divestiture is not always as easy as it might seem. The accumulation of HIF-2α can lead to the formation of both benign and malignant tumors. Merck will retain its current growth pillars of Oncology, Vaccines, Hospital and Animal Health and continue to invest in research and development of breakthrough innovations across all areas of science. The approval was based on results from the Phase III KEYNOTE-177 trial, in which Keytruda significantly reduced the risk of disease progression or death by 40 percent compared with chemotherapy, the current standard of care. Merck plans to spin off about $6.5 billion in assets that represent close to 15% of its total revenue base. During January 2020, Merck announced an exclusive worldwide research collaboration and license agreement with Taiho Pharmaceutical Co., and Astex Pharmaceuticals, a wholly owned subsidiary of Otsuka Pharmaceutical Co., focused on the development of small-molecule inhibitors against several drug targets, including the KRAS oncogene, which are being investigated for treating cancer. Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma, FILE- This May 1, 2018, file photo shows Merck corporate headquarters in Kenilworth, N.J. Merck is posting a 29% jump in fourth-quarter profit and it's spinning off its women's health division and other operations that churn out $6.5 billion in annual revenues. The spinoff will allow both management teams to drive increased responsiveness to the particular needs of their patients … In July, FDA accepted two new supplemental biologics license applications for Keytruda. … NewCo will have a large portfolio of highly profitable and trusted brands consisting of dermatology, pain, respiratory, select cardiovascular products including ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), as well as the rest of Merck’s Diversified Brands, with strong cash flows that will support investments in future growth opportunities. Bridion, indicated for the reversal of two types of neuromuscular blocking agents used during surgery, passed the blockbuster barrier in 2019 with sales of $1.13 billion on growth of 23.3 percent. ProQuad growth was driven primarily by higher volumes and pricing in the United States, as well as volume growth in the EU largely reflecting a competitor supply issue. Mizuho analyst Mara Goldstein wrote to investors that the spinoff should drive higher revenue and dividend growth and increase profit margins. “Over the past several years, we have purposefully shifted the focus of our efforts and resources to our best opportunities for growth,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. Gardasil, Merck’s HPV vaccine, generated sales of $3.74 billion in 2019, an improvement of 18.6 percent. NewCo’s earnings before interest, taxes, depreciation, and amortization (EBITDA) margins are expected to be in the low-to-mid 40% range in the first year post separation and increase over time. As such, LEAP-002, the Phase III trial evaluating the Keytruda plus Lenvima combination as a first-line treatment for advanced HCC, is currently underway and fully enrolled. Cediranib is an investigational oral vascular endothelial growth factor receptor inhibitor, which blocks the growth of blood vessels supporting tumor growth. NewCo will pursue global leadership and focused, sustainable growth in Women’s Health led by the growing and patent-protected NEXPLANON (etonogestrel implant) franchise and fueled by its leading contraceptive and fertility businesses. MK-6482 is an investigational, novel, potent, selective, oral HIF-2α inhibitor being evaluated in a Phase III trial in advanced RCC, a Phase II trial in VHL-associated RCC, and a Phase I/II dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC. NewCo executives expect to establish a leading position in Biosimilars along with its partner, Samsung Bioepis Co., focusing on its current portfolio including Renflexis (infliximab-abda) and Brenzys (etanercept) in immunology and Ontruzant (trastuzumab-dttb) in oncology, and is well-positioned to be a partner in the commercialization of biosimilars worldwide. One issue that may continue to act as a drag is that Merck is targeting a spin-off completion for the first half of 2021. in short, shareholders and employees alike may have to deal with all sorts of changes for a year or more. The transaction is intended to take the form of a tax-free distribution to Merck shareholders of a new publicly traded stock in NewCo. Also in April, Merck announced the presentation of interim data from Cohort B of KEYNOTE-555, a Phase I trial evaluating a 400 milligram every six-week (Q6W) dosing regimen for Keytruda in patients with metastatic melanoma.

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