Gilead Sciences Inc.

Stock Exchange: XNAS • Ticker: GILD • HQ: Foster City, CA, US • Employees: approx. 8,000

Ranking by technical area
Ranking by strategic pillar

Performance

Gilead drops to 8th place, despite being a leader in key areas, including in Patents & Licensing. It has pioneered the use of non-exclusive voluntary licensing beyond HIV/AIDS, and its solid compliance processes protect it from breaching laws and regulations on unethical behaviour. Its new donation programme aims to eliminate hepatitis C virus (HCV) in Georgia. Yet, in R&D, its performance remains low: its relevant pipeline is smaller than the industry average, and it lags in ensuring ethical clinical trial conduct and on clinical data transparency. It falls in pricing, despite leading in certain metrics. It does not, for example, clearly make sales agents accountable or facilitate products’ rational use. Gilead has few capacity building activities, focusing on manufacturing, and limited targeting of local gaps.

Change since 2014

Maintains a low level of transparency regarding its stakeholder engagement activities.

Maintains high standards of ethical behaviour: once again, it has not been found to have breached laws or regulations relating to unethical behaviour.

Maintains comparatively poor approaches for ensuring clinical trials are conducted ethically and for sharing clinical trial data.

Has more products with equitable pricing strategies than in 2014.

No longer provides volume-of-sales information.

Confirms its leadership in Patents & Licensing, having voluntarily agreed non-exclusive licenses for all on-patent products for high-burden communicable diseases.

Has launched a new donation programme aimed at the elimination of hepatitis C in Georgia.

Opportunities

Expand into access strategies for non-communicable diseases. Gilead can apply its access approach for HIV/AIDS and hepatitis C products to its portfolio for non-communicable diseases (NCDs) (e.g., ranolazine (Ranexa®), a second-line treatment for stable angina). This could help address the increasing burden of these conditions in low- and middle-income countries.

Expand licensing approach to more middle income countries. Gilead can consider ways of including more high-prevalence middle income countries in the terms of its hepatitis C licensing arrangements, through, for example, tiered licensing policies.

Share results and lessons learned from donation programme. Gilead’s donation programme for hepatitis C is the first to aim to eliminate this virus. As such, insight into its progress and impact is particularly important to share. Gilead can rigorously monitor and evaluate the drug donation programme it has initiated in Georgia, and then publish its results and lessons learned.

Ensure affordability of products worldwide. Gilead can expand its consideration of socio-economic factors in its inter-country equitable pricing strategies, to help ensure products are globally affordable for different populations. The company can mitigate the risk of mark-ups on HIV/AIDS products by providing pricing guidelines to sales agents.

Expand training approach. Gilead can draw from its experience in compliance training to build capacities of third parties in more areas, taking local needs and capacity gaps into account.

Improve clinical trial transparency. Gilead lags behind the industry in this area. It can ensure its policy for clinical trial data transparency sets out a timeline for publishing results and a protocol for publishing all results, regardless of outcome. The company can also introduce a mechanism for sharing anonymised patient-level data with third parties.

Sales and operations

Gilead is a biopharmaceutical company that operates through one segment: Human Therapeutics. It focuses on HIV/AIDS, liver diseases, haematology and oncology, inflammatory and respiratory diseases and cardiovascular conditions. In 2015, the company announced the acquisition of EpiTherapeutics, a leader in epigenetics.

Gilead markets products in 93 countries within the scope of the Index. The company’s sales have grown steadily since 2014.

Sales in countries in scope
Sales by division
Sales by region

Portfolio and pipeline

Gilead’s has a relatively small portfolio, with 17 medicines for diseases in scope. It has a relatively small pipeline, with 13 R&D projects, that addresses the needs of people in countries in scope.

Its portfolio and pipeline are heavily focused on HIV/AIDS and viral hepatitis, which are the targets of 14 of Gilead’s medicines. A relatively large proportion of Gilead’s pipeline targets high-priority product gaps with low commercial incentive, for example fixed-dose combinations (FDCs) for hepatitis C genotypes 4, 5 and 6.

Products per disease category

Gilead’s portfolio is heavily focused on HIV/AIDS and viral hepatitis. Out of the 17 products in its relevant portfolio, 14 target these diseases.

Several of Gilead’s products have gained marketing authorisation from the FDA since 2014, including: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®) for HIV-1 in 2015, and sofosbuvir/ledipasvir (Harvoni®) for chronic hepatitis C genotype 1, 4, 5 or 6 infection.

Pipeline projects

With Johnson & Johnson, Gilead is  developing two fixed-dose combinations for HIV/AIDS. Whether they can be produced under Gilead’s licensing agreements will depend on the patent status of the regimens’ other compounds.

First-line treatments and essential medicines

Approximately half its products are on the WHO EML and/or are first-line: e.g., sofosbuvir (Sovaldi®), tenofovir disoproxil fumarate (Viread®), and efavirenz/emtricitabine/tenofovir disproxil fumarate (Atripla®).

Pipeline by stage of development
– Innovative medicines and vaccines

Gilead has several innovative medicines in clinical development, targeting hepatitis B virus (HBV), HIV/AIDS and chronic obstructive pulmonary disease (COPD). Presatovir, targeting respiratory syncytial virus, is in phase II trials.

Pipeline by stage of development
– Adaptive medicines and vaccines

Gilead’s pipeline includes fixed-dose combinations for HIV/AIDS and hepatitis C. In January 2016, it applied to the FDA for the approval of tenofovir alafenamide as a once-daily treatment for chronic HBV.

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

 

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