A research programme by the Access to Medicine Foundation

Merck KGaA

Stock Exchange: Frankfurt Stock Exchange Ticker: MRK HQ: Darmstadt, Germany Employees: 50000

Rank

4

Rank 4 in 2016

Score

2.90


Performance

Merck KGaA  turns in a strong performance and holds fourth place. It is innovative with its Merck Global Health Institute, and shows particular strength in targeting R&D priorities and in minimising the risk of corruption and unethical marketing. 

Performance by technical area
Performance by strategic pillar

Management

Rises 2 places to 8th establishing a new sustainable business model: Curafa™, targeting populations in remote areas in Kenya. 

Compliance

Rises 9 places to 2nd. One of the largest risers,  it applies its code of conduct to third parties and non-sales-based incentives are in place for sales agents.

R&D

Holds 2nd place, newly creating the Merck Global Health Institute. A comparatively large proportion of its pipeline aims to address R&D priorities. 

Pricing

Falls 5 places to 11th, overtaken by stronger performers, with comparatively weak registration commitments.

Patents

Falls 2 places to 7th, performing marginally poorer in new IP agreements reached over the period of analysis.

Capacity

Maintains 6th place, with a strong focus on local manufacturing, including technology transfer. 

Donations

Rises from 6th to 5th place with a long-term commitment to eliminate schistosomiasis in 37 countries.


Opportunities

Refine access plans for all current and future Merck Global Health Institute projects. Merck KGaA can further develop its access plans for R&D projects conducted through the Merck Global Health Institute. Currently, Merck KGaA commits to address affordability by minimising development and manufacturing costs to lower the final cost of products. It can build on this commitment by also committing to apply pricing strategies that consider ability to pay, and committing to register products in all endemic countries (for schistosomiasis and malaria) and in all countries in scope (for antimicrobial resistance).

Expand availability and affordability of avelumab (Bavencio®). Merck KGaA can work to develop additional access plans for its current and future indications of avelumab (Bavencio®), an anti-cancer drug that is FDA-approved for a number of cancer types within the scope of the Index. By making this treatment available in countries in scope that have the capacity to administer this drug (including Brazil, India and China) Merck KGaA can help reduce inequity in access to cancer treatment.

Register broad spectrum antibiotics in countries in need. Currently, Merck KGaA does not register cefixime (Denvar) in any priority countries for diseases for which the antibiotic is indicated (kidney diseases, lower respiratory infections, meningitis, or gonorrhoea). It is both on the 2017 WHO Model List of Essential Medicines (WHO EML) and is a first-line treatment. While antibiotic resistance must be considered, many priority countries currently lack access to essential products to treat these infections. Merck KGaA can file cefixime for registration in priority countries.

Consider equitable pricing strategies for additional first-line, WHO EML products. Merck KGaA's gentamicin (Refobacin®) for kidney diseases; lower respiratory infections; maternal sepsis; meningitis; and neonatal sepsis and infections is an-off patent first-line product on the WHO EML with no access plans  in place. The company could provide equitable pricing strategies for corresponding priority countries. Similarly, Merck KGaA’s itraconazole (Candistat) for meningitis is an off-patent, first-line product on the WHO EML with no access plans in place. The company could apply equitable pricing strategies to these products in priority countries including, Angola, Chad, Congo, Dem. Rep., Ethiopia, India, Nigeria, and Uganda.


Change since 2016

  • Joined the Drugs for Neglected Diseases initiative’s NTD Drug Discovery Booster to accelerate the development of early-stage projects for Chagas disease and leishmaniasis.
  • Signed a Memorandum of Understanding in December 2017 to support the development of a new vaccine manufacturing plant in Ghana.
  • Joined Access Accelerated with multiple initiatives including the Merck Capacity Advancement Program. It has committed to measure impact and share results publicly via the Access Observatory.
  • Discloses publicly the patent statuses for small molecules in scope via the Pat-INFORMED platform.
  • Established the Merck Global Health Institute to accelerate R&D, incorporate access provisions and build capacity for projects and initiatives targeting schistosomiasis, malaria and bacterial infections.

Pipeline​ and Portfolio

for diseases and countries in scope

Pipeline

Mid-sized pipeline: 74* R&D projects for diseases in scope (59 medicines; 7 diagnostics; 6 platform technologies; 2 vector control products; 1 therapeutic vaccine).
Clinical candidates: 30, including praziquantel for the treatment of schistosomiasis in children and atacicept for the treatment of kidney diseases.
Regulatory approvals: 1, avelumab (Bavencio®) for the treatment of bladder cancer.
R&D focus: non-communicable diseases (cancer, diabetes, hypertensive heart disease and kidney diseases), communicable diseases (malaria) and neglected tropical diseases (schistosomiasis).
Access provisions: for 22 projects, most commonly registration commitments.

Portfolio

Mid-sized portfolio: 47 products for diseases in scope (46 medicines; 1 diagnostic). 
Portfolio focus: non-communicable diseases (hypertensive heart disease, ischaemic heart disease and diabetes mellitus) and communicable diseases (lower respiratory infections).
Essential medicines: 59% of Merck KGaA's medicines are currently listed on the 2017 WHO Model List of Essential Medicines (WHO EML).
First-line treatments: 63% of Merck KGaA's medicines have first-line indications for diseases in scope.

Projects in the pipeline: 74**
Products on the market: 47
Projects for R&D priority targets with access provisions: 13
Essential medicines with first-line indications: 25

Business context

Three business units: Healthcare; Life Science; and Performance Materials. Its Healthcare business has seven therapeutic areas (allergen immunotherapy; consumer health; endocrinology; general medicine; fertility; neurology and immunology; and oncology).

M&A news: 2017 divestment of biosimilar business, focused on oncology and autoimmune diseases, to Fresenius Kabi. 2018 ongoing divestment (expected to conclude fourth quarter 2018) of global Consumer Health business to Procter & Gamble.

Presence in emerging markets: In 2018, Merck KGaA reports sales in 76 countries in scope; similar to reported sales in the 2016 Index. It reports that around 40% of its sales in 2017 came from Middle East, Africa, Asia-Pacific and Latin America.

Sales in countries in scope
Net sales by geographic region

*Projects that target multiple product types are counted more than once. 
**Figure excludes 26 projects that do not fall into the listed phases of development: e.g., technical lifecycle projects, diagnostics, platform technologies, vector control products, investigator sponsored trials and Phase IV projects. 
***Neglected Tropical Diseases, while also communicable, are highlighted separately throughout the Index. See Appendix II. 
†See Appendix IV for definition. 
‡2013 data not comparable due to changes in company reporting practices


Learn more

View our detailed overview of each company’s performance in the Index, including breakdowns of their product portfolios and R&D pipelines.