Headquarters: Whitehouse Station, NJ
Year Established: 1889
Revenues: $39,807 (+1%)
Pharma Revenues: $35,151 (+1%)
Net Income: $5,712 (+28%)
R&D: $7,194 (+7%)
TOP SELLING DRUGS
|Proquad, MMR, and Varivax||vaccines||$1,640||9%|
Headquartered in Whitehouse Station, NJ, Merck climbed a spot to number three with 2016 revenue of $39.8 billion. The company operates in over 100 countries, and 55% of its total revenue comes from sales outside U.S. markets. The global human health segment, or pharmaceuticals, is the highest revenue-generating segment at the company and contributed nearly 88% of total revenues. This segment includes various franchises like oncology, vaccines, hospital acute care, diabetes, and women’s health.
Blockbusters lead the way
Merck’s pharmaceuticals segment has several blockbuster drugs with a yearly contribution of over $1 billion each. Keytruda is part of Merck’s immuno-oncology franchise and used to treat non-small cell lung cancer as well as melanoma, a type of skin cancer. Merck launched Keytruda in the fourth quarter of 2014. Last year it Keytruda’s global sales were $1.4 billion, a nearly 150% growth in revenues as compared to $566 million in 2015.
Januvia and Janumet are two of Merck’s blockbuster drugs in the diabetes franchise. These drugs are used to lower blood sugar levels in patients with type two diabetes and combined sales for these drugs were $6 billion.
Remicade, a top-selling drug for the treatment of inflammatory disorders, is losing its market share due to the entry of generic competitors and biosimilars following the loss of exclusivity in European markets. Revenues fell 29% to $1.3 billion.
Simponi is another drug in the immunology franchise that saw revenues rise 11% to $766 million while the combined revenues of cardiovascular drugs Zetia and Vytorin fell to $3.7 billion due to the loss of exclusivity of Vytorin in the U.S.
The Gardasil franchise is Merck’s leading vaccines franchise for the prevention of certain strains of human papillomavirus (HPV). Total sales of the Gardasil franchise in 2016 were $2.2 billion, an increase of 14%.
Merck entered a $280 million cancer collaboration with Complix, a biopharmaceutical company developing a pipeline of protein therapeutics called alphabodies for the treatment of cancer and severe autoimmune diseases. The strategic drug discovery collaboration through Merck’s subsidiary, Merck Sharp & Dohme Corp. (MSD), will focus on developing cell-penetrating alphabodies (CPABs) for the treatment of cancer. Complix will use its proprietary Alphabody platform to deliver CPABs against up to two intracellular cancer targets. MSD will fund related research activities and has an option to the exclusive, worldwide rights for any of the resulting compounds.
Adimab entered into an agreement with Merck to transfer its antibody technology to Merck Research Labs for the discovery and optimization of monoclonal and bispecific therapeutic antibody candidates. This technology transfer expands an ongoing collaboration initiated in 2009 that has resulted in several undisclosed therapeutic candidates for Merck. Adimab will transfer and license its antibody discovery and optimization platform to Merck. Merck will receive a custom human antibody library and will obtain a license to the Adimab platform for use in all therapeutic areas and targets. Merck has also secured an option to receive continued improvements to the Adimab platform, including access to new antibody libraries.
AbCellera has entered a collaboration with Merck to generate antibodies against an undisclosed disease target. AbCellera will apply its high-throughput antibody discovery platform to identify antibodies that specifically modulate target function. Merck has the option to develop antibody candidates identified through the collaboration for specified therapeutic applications.
In another cancer pact, ImmunoGen and Merck joined forces to evaluate an ovarian cancer drug combo. The clinical research collaboration was set up to assess ImmunoGen’s mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), for the treatment of patients with FRα-positive ovarian cancer. ImmunoGen is conducting a Phase Ib/II trial evaluating mirvetuximab soravtansine for FRα-positive ovarian cancer used in combination with other anticancer agents. The assessment of mirvetuximab soravtansine with Keytruda will be added to this trial, with Merck supplying the Keytruda. The agreement may be expanded to include a subsequent Phase III clinical trial.
Merck and Moderna Therapeutics formed a $200 million strategic collaboration and license agreement to develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines. The collaboration will combine Merck’s established leadership in immuno-oncology with Moderna’s pioneering mRNA vaccine technology and GMP manufacturing capabilities to advance individually tailored cancer vaccines for patients across a spectrum of cancers.
Moderna and Merck will develop personalized cancer vaccines that utilize Moderna’s mRNA vaccine technology to encode a patient’s specific neoantigens, unique mutations present in that specific patient’s tumor. When injected into a patient, the vaccine will be designed to elicit a specific immune response that will recognize and destroy cancer cells. The companies believe that the mRNA-based personalized cancer vaccines’ ability to specifically activate an individual patient’s immune system has the potential to be synergistic with checkpoint inhibitor therapies, including Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab). In addition, Moderna has developed a rapid cycle time, small-batch manufacturing technique that will uniquely allow the company to supply vaccines tailored to individual patients within weeks.
The development program will entail multiple studies in several types of cancer and include the evaluation of mRNA-based personalized cancer vaccines in combination with Merck’s Keytruda (pembrolizumab). Moderna will also utilize the upfront payment to fund a portion of the build-out of a GMP manufacturing facility in suburban Boston for the purpose of personalized cancer vaccine manufacturing.
In June 2016 Merck bought the clinical-stage biotech Afferent Pharmaceuticals in a deal worth up to $1.25 billion. The move gave Merck access to Afferent’s lead investigational candidate AF-219 for chronic cough treatment. Merck purchased all outstanding shares of Afferent for an upfront fee of $500 million, and could pay an extra $750 million linked to certain clinical development and commercial milestones.
AF-219 is a selective, non-narcotic, orally-administered P2X3 antagonist currently being evaluated in a Phase IIb clinical trial for the treatment of refractory, chronic cough, as well as in a Phase II clinical trial in idiopathic pulmonary fibrosis (IPF) with cough.
P2X3 receptors are believed to play a key role in the sensitization of certain sensory nerves, which become activated under pathological conditions mediated by a common cellular signal, ATP, when it is released in high concentrations due to cellular distress following injury or infection. Afferent’s compounds are designed to selectively block ATP activation of P2X3 channels, potentially reducing a range of sensory signs and symptoms.
Merck also acquired IOmet Pharma, bolstering its preclinical immuno-oncology pipeline. The UK-based drug discovery company is focused on cancer immunotherapy and cancer metabolism. Merck gained its preclinical pipeline of IDO (indoleamine-2,3-dioxygenase 1), TDO (tryptophan-2,3-dioxygenase), and dual-acting IDO/TDO inhibitors. IOmet became a wholly owned subsidiary of Merck.
Also of note, in March 2016, after 20 years, Merck and Sanofi Pasteur ended their joint vaccines operations in Europe. After concluding their joint venture, both companies said the plan was to integrate their respective European vaccine businesses into their operations, independently manage their product portfolios and pursue separate growth strategies in Europe.
The joint venture Sanofi Pasteur MSD, owned on a 50/50 basis, was created in 1994 to develop and commercialize vaccines from both companies’ pipelines in 19 European countries. Numerous vaccines from Sanofi and MSD’s development pipelines were launched, addressing key unmet medical needs. While the joint venture was successful over the past two decades from a public health and commercial perspective, the companies said that after considering their individual strategic priorities, alongside the economic and regulatory environments for vaccine operations in the EU, it was best to manage their respective vaccine product portfolios independently.