Novartis AG

Stock Exchange: XSWX • Ticker: NOVN • HQ: Basel, Switzerland • Employees: 122,966

Ranking by technical area
Ranking by strategic pillar

Performance

Novartis rises one place to 3rd. It has an access strategy embedded in its broader corporate strategy, and which addresses all segments of the socio-economic pyramid. It is a leader in filing products for registration, and has applied equitable pricing to significantly more products than in 2014. It is also a leader in donations: two programmes stand out for their reach and broad coverage, which both target neglected tropical diseases (food-borne trematodiases and leprosy). Novartis takes a comprehensive and innovative approach to capacity building, consistently addressing local needs. However, its strengths are not reflected in its compliance system or in the transparency of its marketing and lobbying activities. Novartis also does not publish patent statuses and has not engaged in licensing.

Change since 2014

Established the Novartis Access programme in 2015, which offers a portfolio of 15 on- and off-patent products for non-communicable diseases (NCDs) at USD 1 per month, per treatment.

Is developing an approach that will value the environmental, social and economic impact of some of its initiatives.

Falls back in compliance, with a settlement following a case of corruption in a country in scope (China).

Established a Global Health Group for improving R&D by building a better understanding of unmet medical needs in low-income countries and responding to them.

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

Has more than doubled the number of its products with equitable pricing.

No improvement in its accountability for its sales agents’ pricing practices.

Has not published the status of its patents.

Partnered with national regulatory authorities in Egypt and Mexico in 2015 to improve awareness of the importance of pharmacovigilance.

Opportunities

Plan for the long-term sustainability of its Novartis Access programme. Novartis can take steps to ensure the longevity of its new Novartis Access programme. If the programme proves not to be economically sustainable, Novartis can agree with local stakeholders to ensure patients covered by this programme retain access to medicines following the pilot phase.

Continue to target known needs through innovative and adaptive R&D. Novartis can leverage its strength at engaging in R&D for global health priorities. The company can continue to develop innovative medicines that target defined, high-priority product gaps, and continue its strategic expansion of adaptive R&D for high-burden diseases.

Increase sensitivity of affordability assessments in low- and middle-income countries. Novartis can expand its consideration of socio-economic factors in its inter-country equitable pricing strategies, to ensure products are affordable, for example, for omalizumab (Xolair®), which is the only registered recombinant monoclonal antibody to treat moderate to severe allergic asthma.

Operationalise commitment to voluntary licensing. Novartis can operationalise and broaden its commitment to engaging in voluntary licensing in Least Developed Countries (LDCs) to increase access to its patented products. Further, Novartis can broaden this commitment to enable supply to other countries.

Strengthen and innovate compliance system. Novartis has general guidelines for interacting with public officials and supporting political and policy advocacy. It can strengthen its compliance system by building on these with new, specific guidelines governing all interactions with different actors along the medicines supply chain.

Ensure access to products on the WHO EML. Novartis has one of the largest numbers of products on the WHO Model Essential Medicines List (EML). It can evaluate access barriers to these products in all low- and middle-income countries. It can ensure their availability and affordability, aligning with demand and the availability of alternative products in specific countries.

Sales and operations

Novartis is organised in three divisions: Innovative Medicines, Alcon (eye care products) and Sandoz (generic medicines). Its pharmaceutical division focuses on: cardiovascular disease, respiratory diseases, neuroscience, immunology, dermatology and oncology. The company aims to expand its portfolio with products for infectious diseases, regenerative medicine and aging. Novartis’s focus has recently shifted: in 2015, the company divested its vaccine business (excluding influenza vaccines) to GSK in an assets swap that included the acquisition of GSK’s marketed oncology portfolio. As part of the deal, the two companies created a new consumer healthcare business, with majority control being retained by GSK. Novartis has sales in 77 countries within the scope of the Index.

Sales in countries in scope
Sales by division
Sales by region

Portfolio and pipeline

Novartis has one of the largest portfolios for relevant diseases of all companies in the Index, and one of the largest pipelines of projects that address the needs of people in countries in scope: with 74 products and 45 R&D projects.

In Novartis’s portfolio, 50 medicines target one or more NCDs, including hypertensive and ischaemic heart disease and unipolar depressive disorders. In Q4 2015, the company gained EU approval for sacubitril/valasartan (Entresto®), which has a new mechanism of action for treating heart failure. Novartis expects to file for marketing authorisation for three medicines for relevant diseases in the next two years, including for cardiovascular disease and asthma.

Products per disease category

Novartis has 74 medicines for relevant diseases, mainly for infectious diseases, heart diseases, mental health conditions and respiratory diseases.

Novartis is developing medicines for ten NCDs, six communicable diseases, four neglected tropical diseases (NTDs) and three maternal and neonatal health conditions. Its candidates for malaria, TB and NTDs target high-priority product gaps with low commercial incentive. Several of its product candidates have progressed along the pipeline since 2014.

Pipeline projects

Novartis is collaborating to develop medicines for malaria and dengue, among others.

First-line treatments and essential medicines

A high proportion of Novartis’ products for diseases in scope are on the WHO EML and/or that are first-line treatments: e.g., omalizumab (Xolair®), budesonide (Miflonide®) and lamprene/rimactane/dapsone.

Pipeline by stage of development
– Innovative medicines and vaccines

Novartis is developing innovative medicines for all four disease categories. The majority are in early stages of development.

Pipeline by stage of development
– Adaptive medicines and vaccines

Novartis is adapting products for malaria, TB, maternal haemorrhage, hypertensive heart disease, lower respiratory infections, diarrhoeal diseases, meningitis and kidney diseases.

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

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