UPDATE: Merck Highlights Strategic Initiative

Company Provides Updates on Near-Term Opportunities and Immuno-Oncology Strategy Announced Sale of Consumer Care Business to Bayer AG for $14.2 Billion; Enters into Worldwide Collaboration with Bayer to Market and Develop Novel Therapies for Cardiovascular Disease MK-3475 BLA Accepted for Priority Review by FDA; Company Announced Plans to File in EU in 2014 Provided Updates on Clinical Development Programs for Oncology, Hepatitis C and HIV Confirmed Plans to File Odanacatib for the Treatment of Osteoporosis in Second Half of 2014 BOSTON--(BUSINESS WIRE)-- Merck MRK, known as MSD outside the United States and Canada, today is hosting an Investor Briefing at the company's research facility in Boston. The briefing is also available via webcast at www.merck.com starting at 9:00 a.m. EDT. Members of the company's senior management team provided updates on the progress Merck has made on its multi-year, strategic initiative to sharpen its commercial and research and development (R&D) focus, bolster its innovative pipeline and accelerate efforts to redesign its operating model and reduce its cost base. New, Focused Operating Model Merck has implemented a focused, more agile operating model and a more flexible cost structure in order to drive growth and productivity for the long term. This has allowed the company to reduce costs, while at the same time take proactive steps to further sharpen its R&D and commercial focus and bolster its innovative pipeline. This includes greater integration between the company's commercial and R&D organizations and improved therapeutic, pipeline and market prioritization to focus on the best opportunities for growth. “We're focusing on improving our growth opportunities by investing in the right programs, products and markets,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “Merck is about translating cutting-edge science into medicines and vaccines that save and improve lives throughout the world. By bringing to market new products that make a meaningful difference to patients, payers and providers, we'll continue to drive value for our shareholders and society.” Merck announced in January that it was evaluating strategic options for all areas of the business, including Consumer Care and Animal Health, to determine whether or not they are core to its strategy. As a result, Merck today announced the sale of its Consumer Care business to Bayer AG for $14.2 billion and entered into a worldwide collaboration with Bayer to market and develop a novel portfolio of soluble guanylate cyclase (sGC) modulators for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). As part of the collaboration, Bayer will receive a $1 billion up-front payment with the potential for additional milestone payments upon the achievement of agreed-upon sales goals. During today's Investor Briefing, Merck said it will continue to explore ways to augment its Animal Health business. The company continues to view the business as one that will generate long-term shareholder value. Advancing a Suite of Opportunities Merck's pipeline contains many promising candidates that represent a suite of near- and long-term opportunities that will drive growth and shareholder value. The company has prioritized its R&D efforts to focus on innovative candidates with meaningful, differentiated attributes. At the same time, Merck has increased its commercial focus on key therapeutic areas that provide the best opportunities for the business and deliver the greatest value for customers, including diabetes, acute hospital care, vaccines and oncology. During the meeting, company executives reaffirmed Merck's objective of being the premier research-intensive biopharmaceutical company. The executives also discussed progress made towards prioritizing the company's R&D portfolio and provided updates on advances in the company's late-stage pipeline and plans for expanding its clinical programs to advance its novel candidates in hepatitis C, HIV, diabetes and immuno-oncology. Merck said it also anticipates several regulatory actions and potential product launches in 2014 including: Launches GRASTEK (Timothy Grass Pollen Allergen Extract), a sublingual allergen immunotherapy tablet for grass pollen-induced allergic rhinitis RAGWITEK (Short Ragweed Pollen Allergen Extract), a sublingual allergen immunotherapy tablet for ragweed pollen-induced allergic rhinitis Under Review MK-3475, an investigational anti-PD-1 antibody for advanced melanoma Suvorexant, an investigational orexin inhibitor for the treatment of insomnia ZONTIVITY (vorapaxar), an investigational, novel PAR-1 antagonist for reduction of atherothrombotic events in patients with a prior heart attack or with peripheral arterial disease and no history of stroke or transient ischemic attack V503, an investigational 9-valent HPV vaccine Vaniprevir, an investigational, novel protease inhibitor for the treatment of hepatitis C (under review in Japan) Filings Anticipated in 2014 Sugammadex, an investigational medicine for the reversal of neuromuscular blockade Odanacatib, an investigational, novel cathespin K inhibitor for the treatment of osteoporosis The company confirmed plans to submit a New Drug Application (NDA) for odanacatib in the second half of 2014 and said that data from its large fracture outcomes study have been submitted for presentation at a medical meeting later this year. In the Phase 3 fracture study, odanacatib substantially reduced the risk of osteoporotic fractures vs. placebo, including vertebral, non-vertebral and hip fractures, and the risk reduction was robust and sustained. Adverse experiences were generally balanced between the odanacatib and placebo groups. Among adjudicated adverse effects associated with odanacatib, morphea (areas of skin thickening with itching) was reported uncommonly (<0.2%), with improvement after discontinuation of treatment, and femoral shaft fractures of an atypical type were rare (<0.1%). Both were higher than placebo. There were no reported cases of osteonecrosis of the jaw. Numerical imbalances were also seen for adjudicated atrial fibrillation and strokes, though major cardiovascular events were balanced overall. Additional late-stage pipeline opportunities where Merck has a legacy of leadership and an established global presence were also discussed: In hepatitis C, the company has initiated Phase 3 trials for MK-5172/MK-8742, its all-oral combination regimen, and also plans to initiate studies in combination with sofosbuvir for evaluating shorter durations of therapy. In HIV, the company plans to commence a Phase 3 trial in the fourth quarter of 2014 for its non-nucleoside reverse transcriptase inhibitor, doravirine (MK-1439), and for raltegravir once-daily, a new formulation of its integrase inhibitor ISENTRESS. In diabetes, the company plans to file omarigliptin, a once-weekly DPP-4 inhibitor, in Japan by the end of 2014. In addition, in collaboration with Pfizer, Merck continues to evaluate ertugliflozin, an investigational oral sodium glucose cotransporter (SGLT2) inhibitor, in Phase 3 trials. Delivering in Immuno-oncology Merck is investing to be a leader in oncology and is focused on advancing MK-3475. The company announced that the FDA has accepted its Biologics License Application (BLA) for MK-3475 for the treatment of advanced melanoma in patients previously treated with ipilimumab and granted priority review status. The PDUFA date for the BLA is October 28, 2014. Conference and Webcast Information There will be a live webcast of the event available on Merck's website at www.merck.com starting at 9:00 a.m. EDT. Software needed to listen to the webcast may be obtained on the corporate website and should be downloaded prior to the beginning of the webcast. A replay of the webcast will be available by the end of the day on May 6, 2014. Institutional investors, analysts and members of the media also can participate in the event by dialing (706) 634-2289 or (877) 214-9289 and using ID code number 42688075.