Merck KGaA

Stock Exchange: XFRA • Ticker: MRK • HQ: Darmstadt, Germany • Employees: 49,613

Ranking by technical area
Ranking by strategic pillar

Performance

Merck KGaA once again rises two places, having improved in most areas. It has access-related targets that align with the Sustainable Development Goals, and clearly holds third parties to the same ethical standards as its own employees. It engages in R&D partnerships and shares IP and clinical trial data for research purposes. It has filed to register a high proportion of its newest products in high-burden countries and it adapts its brochures and packaging to suit local needs in multiple ways. However, it still applies equitable pricing to only a small portion of its products. It has one of the most transparent approaches to IP management, but has been fined for anti-competitive behaviour. It is now a leader in capacity building, with a range of initiatives, including a long-term project for identifying falsified medicines.

Change since 2014

Newly aligns access targets with the Sustainable Development Goals.

Does not publish progress made against access-to-medicine targets.

Has signed the Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance.

Has equitable pricing strategies for the same number of products as in 2014.

Has improved its accountability for its sales agents’ pricing practices.

Clearly indicates where it is prepared to waive patent rights, and where and what products it is prepared to license.

Publishes information about the patents its holds in countries in scope.

Has launched a three-year malaria research collaboration with the University of Namibia, in support of national malaria control programmes in Namibia, Botswana and Zambia.

Opportunities

Target local capacity building needs in Africa. Merck KGaA intends to strategically expand its presence in Africa between 2015 and 2020. The company can ensure its capacity building activities (including in manufacturing and areas outside the pharmaceutical value chain) continually respond to local needs, and draw on ongoing input from local stakeholders. The company can also evaluate impact and publish its findings.

Expand equitable pricing strategy to more products. Merck KGaA can apply its equitable pricing strategy to more products, including all of its first line medicines for diabetes. It can take account of more socio-economic factors in its inter-country equitable pricing strategies.

Align access commitments and R&D early. Merck KGaA can build on its new “Access to Health in Developing Countries” charters, which focus on intellectual property rights and pricing, to ensure it makes access plans for its product candidates before they gain marketing approval. The company can put access provisions in place for its in-house (non-collaborative) R&D projects.

Ensure access to mental health products on the WHO EML. Merck KGaA is the only company targeting all mental health conditions in scope. It can assess access barriers for these conditions and ensure the availability and affordability of its mental health products, especially those listed on the WHO Model Essential Medicine List (EML), in all low- and middle-income countries that need them. It can align with demand and with the availability of alternative products in specific countries.

Sales and operations

Merck KGaA reorganised its business in October 2014 and now operates through three business sectors: Healthcare (comprising the Biopharma, Consumer Health, Allergopharma, and Biosimilars businesses), Life Science and Performance Materials. The Healthcare business focuses on: oncology, immunology, neurology, endocrinology and cardiovascular diseases. In November 2014, the company announced a partnership with Pfizer to jointly develop and commercialize immuno-oncology products. About one third of Merck KGaA’s sales are generated in emerging markets and the company has operation in 77 countries within the scope of the Index.

Sales in countries in scope
Sales by division
Sales by region

Portfolio and pipeline

Merck KGaA has a mid-sized portfolio of 58 products for diseases relevant to the Index. It has a mid-sized pipeline of 20 R&D projects that address the needs of people in countries in scope.

To date, the company’s focus for low- and middle-income countries has been on medicines and diagnostics. Merck KGaA’s relevant portfolio has a strong focus on non-communicable diseases (NCDs), covering: all mental health conditions in scope; hypertensive and ischaemic heart disease; and diabetes.

Products per disease category

Merck KGaA’s medicines portfolio has a strong focus on NCDs. Its four diagnostics address HIV/AIDS, malaria, and TB.

Its R&D focuses on malaria and schistosomiasis, as well as diabetes. Merck KGaA is developing diagnostics for HIV/AIDS and malaria that target needs in countries in scope. It is also working with Instituto de Biologia Experimental e Tecnológic to develop a screening platform for the discovery of new anti-malarials. Over half of the company’s projects target high-priority product gaps with low commercial incentive. Since 2014, Merck KGaA’s collaborative project to develop a paediatric formulation of praziquantel moved from pre-clinical to phase II of clinical development.

Pipeline projects

Merck KGaA collaborates with Astellas in the Pediatric Praziquantel Consortium, which plans to promote access to a new formulation of praziquantel, for example, via procurement by established organisations.

First-line treatments and essential medicines

Merck KGaA has 45 medicines listed on the WHO EML and/or as first-line treatments: e.g., bisoprolol/amlodipine, metformin (Glucophage®) and praziquantel.

Pipeline by stage of development
– Innovative medicines and vaccines

Merck KGaA’s innovative pipeline includes four new investigational medicines, all in early stages of development, for malaria and Neglected Tropical Diseases (NTDs).

Pipeline by stage of development
– Adaptive medicines and vaccines

Merck KGaA is adapting several products, including: a fixed-dose combination; pre-diabetes expansion; and smaller tablet of metformin (Glucophage®) to target countries in scope.

Please refer to the pdf of the report card (that can be downloaded here) for information on Merck KGaA’s  performance per technical area.

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