Revenues: $42,294 (+5%)
Pharma Revenues: $37,689 (+6%)
Net Income: $6,220 (>100%)
R&D: $9,752 (-6%)
TOP SELLING DRUGS
Merck’s worldwide pharma sales were $37.7 billion in 2018, an increase of 6% compared with 2017. Growth was driven primarily by higher oncology drug sales, particularly from star pupil Keytruda—sales skyrocketed 88% from the year before to reach $7.2 billion. Revenue related to Lynparza and Lenvima also helped bottom line growth. Other revenue generators included higher sales of vaccines, driven primarily by human papillomavirus (HPV) vaccine Gardasil/Gardasil 9, as well as higher sales in the hospital acute care franchise, attributable to Bridion and Noxafil.
Growth in 2018 was hindered by declines in the virology franchise, including lower sales of hepatitis C virus treatment Zepatier, as well as lower sales of shingles vaccine Zostavax. Generic and biosimilar competition for cardiovascular drugs Zetia and Vytorin, and immunology product Remicade, also hurt growth.
During the year, Merck continued to build its oncology portfolio through acquisition and collaboration. In February it bought virus-based cancer drug firm Viralytics for $394 million. The deal gave Merck full rights to Cavatak, Viralytics’ investigational oncolytic immunotherapy that is based on the company’s proprietary formulation of an oncolytic virus that has been shown to preferentially infect and kill cancer cells. Cavatak is currently being evaluated in multiple Phase 1 and 2 trials, with Keytruda—the two companies formed a partnership back in 2015 to study the use of the Cavatak and Keytruda combination in melanoma, prostate, lung and bladder cancers.
With Dragonfly Therapeutics, Merck entered a deal to discover immunotherapies for solid tumor cancers, under which Merck has the option to license exclusive worldwide rights to products developed using Dragonfly’s TriNKET technology platform for a number of solid-tumor programs.
Moderna Therapeutics and Merck expanded their 2016 collaboration to develop and commercialize personalized messenger RNA (mRNA) cancer vaccines to now include shared antigen mRNA cancer vaccines including mRNA-5671, Moderna’s mRNA KRAS cancer vaccine. The two companies will now advance jointly mRNA-5671 in human studies, and plan to conduct combination studies with additional immuno-oncology therapies.
Evelo Biosciences entered into a clinical trial collaboration with Merck to evaluate EDP1503 in combination with Keytruda in multiple cancer indications; Rexahn Pharmaceuticals also entered into a clinical trial agreement to evaluate the combination of its RX-5902 and Keytruda in a Phase 2 breast cancer trial; Immutep and Merck are evaluating the combination of Immutep’s lead immunotherapy product candidate eftilagimod alpha with Keytruda; and with Eisai, Merck partnered for the worldwide co-development and co-commercialization of cancer drug Lenvima—the companies will develop and commercialize Lenvima jointly, both as monotherapy and in combination with Keytruda.
Regulatory milestones and clinical progress
Keytruda continued to spread its wings during the year with multiple new indications across several tumor types, including approval from FDA for the treatment of cervical cancer, a type of non-Hodgkin lymphoma, hepatocellular carcinoma, Merkel cell carcinoma, and in combination with chemotherapy for the treatment of a type of lung cancer. It also received approvals from the European Commission, as well as Chinese and Japanese regulators.
Lynparza, which is being developed in a collaboration with AstraZeneca, received FDA approval for use in breast cancer and ovarian cancer. Additionally, Lenvima was approved in the U.S., EU, Japan and China for the treatment of hepatocellular carcinoma. The FDA and EC also approved two new HIV-1 medicines: Delstrigo, a once-daily fixed dose combination tablet of doravirine, lamivudine and tenofovir disoproxil fumarate; and Pifeltro (doravirine), a new non-nucleoside reverse transcriptase inhibitor to be administered in combination with other antiretroviral medicines.
In addition to the recent approvals, Merck has continued to advance its late-stage pipeline with several regulatory submissions. Keytruda is under review in the U.S. in combination with axitinib for renal cell carcinoma and has been granted Priority Review by the FDA.
The company’s Phase 3 oncology programs includes Keytruda in the therapeutic areas of breast, cervical, colorectal, esophageal, gastric, hepatocellular, mesothelioma, nasopharyngeal, ovarian, renal and small-cell lung cancers; Lynparza for pancreatic and prostate cancer; and Lenvima in combination with Keytruda for endometrial cancer.
Additionally, the company has candidates in Phase 3 clinical development in several other therapeutic areas, including V114, a vaccine for pneumococcal disease that received Breakthrough Therapy designation; MK-7264, gefapixant, a selective, non-narcotic, orally-administered P2X3-receptor agonist being developed for the treatment of refractory, chronic cough; and MK-1242, vericiguat, an investigational treatment for heart failure.
On the drug discovery front, Merck and IRBM formed a new agreement in the peptide therapeutics area, continuing their long-standing history of collaboration that began in 2010.
According to the companies, there has been increasing interest in peptide research over the last 15 years. The pharma industry continues to make significant preclinical and clinical investments in peptide-based therapeutics for different areas, including metabolic diseases, oncology and cardiovascular disease. Over the last decade there have been numerous technological advancements in this field. Now characteristics that were previously considered a liability for peptides, such as screening systems for lead identification, half-life, stability, solubility, formulation and delivery routes, are no longer considered insurmountable obstacles.
IRBM has built broad expertise in peptide drug development, from initial target identification to the development of a clinical candidate with the required properties in terms of specificity, potency, pharmacokinetics, metabolism and toxicology. For this project, IRBM will be applying its expertise in phage display peptide library design and screening and in chemical peptide synthesis and optimization, to identify potential peptide leads for a specific Merck target.