Regeneron Therapeutic - Product Scorecard

Company: Regeneron

Type: Covid-19 Therapeutic
Product (brand name): Casivirimab & imdevimab (REGEN-COV)
0%
compliance
with criteria
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Explore the results of PAF’s research into the behaviour of Regeneron. Each section is given an overall score; individual criteria are also scored (see icon following the criteria heading).

Click on ‘Explanation about the score’ sign next to each entry to expand and learn more.

Category A: Commitments and Accountability

The company should publicly commit to human rights in relation to product development and marketing, by adopting an official human rights policy statement recognising the right to the highest attainable standard of health. The company should endeavour to integrate human rights into its strategies, policies, programmes, projects, and activities.

The company should also have a publicly available global access plan for their Covid-19 product, based on human rights standards, with measurable targets and lines of accountability.

A1: Does Regeneron publish a global access plan for its product?

Regeneron is collaborating with Roche to increase global supply of REGEN-COV: “The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.”

Apart from this, the company has not published a concrete plan for maximising access to REGEN-COV. 

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A2: Does Regeneron commit to comply with human rights standards in relation to product development and marketing?

Regeneron has published a statement on human rights, but does not endorse the UN Guiding Principles on Business and Human Rights.

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Category C: International cooperation

The company should constructively engage with international initiatives for the equitable distribution of vaccines and therapeutics, such as the Covid-19 Technology Access Pool (C-TAP) or the Medicines Patent Pool (MPP), and the ACT Accelerator (COVAX). The company should also publicly commit to not enforcing the exclusive rights of Covid-19 related patents, and enter into non-exclusive, transparent licensing agreements for its Covid-19 products with other companies.

C1: Does Regeneron commit to C-TAP or MPP?

Regeneron does not commit to C-TAP or the MPP.

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C2: Does Regeneron commit to not enforcing the exclusive rights of Covid-19 related patents?

Regeneron has not made a commitment not to enforce patents

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C3: Does Regeneron supply to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator?

Regeneron has not signed an agreement with the therapeutics pillar of the ACT Accelerator.

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C4: Does Regeneron agree to license its Covid-19 medical products to other companies?

Regeneron has entered into a full licensing deal with Roche and a development and commercialization deal with Chugai.

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Category E: Equality, non-discrimination & equity

The company should engage in efforts to further equitable distribution of Covid-19 vaccines/therapeutics, by equitably distributing its supplies globally, devising fair pricing strategies, and making the active ingredient for its product available to other manufacturers. The company should also engage in full technology transfer to other manufacturers, including the necessary transfer of skills, legal components, knowledge and intellectual property. Where applicable, the company should agree to waive rights in regulatory test data, and refrain from enforcing TRIPS+ measures.

E1: Does Regeneron make the active ingredient available on reasonable grounds? [Only for therapeutics]

Regeneron does not make the active ingredient available to other manufacturers.

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E2: Does Regeneron commit to full technology transfer to other manufacturers?

Regeneron is collaborating with Roche, and does technology transfer to them. It also has a deal with Chugai which includes very limited technology transfer in the form of ‘development and commercialization rights’.

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E3: Does Regeneron commit to non-profit, ‘fair’, or differential pricing?

Regeneron has not committed to non-profit or ‘fair’ pricing so far.

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E4: Does Regeneron equitably distribute supplies globally? [Only applies to vaccines]

[Only applies to vaccines]

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E5: Does Regeneron not seek protection beyond the minimum criteria in TRIPS, or not enforce TRIPS+ measures? [where applicable]

No information has been found on this criterion.

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E6: Does Regeneron agree to waive exclusive rights in regulatory test data? [where applicable]

No information has been found on this criterion.

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Category T: Transparency

The company should be as transparent as possible, by publishing its research and development costs, profit margin, average costs of production, and production capacity for its Covid-19 product. It should also disclose the amount of public subsidies received during product development and/or testing. Licensing agreements should also be made publicly available and clinical trials should be registered in public repositories.

T1: Does Regeneron publish its R&D costs?

Regeneron has published its research and development costs for 2021, but these are not specific to REGN-COV2.

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T2: Does Regeneron publish its profit margin?

Regeneron states that it made 2.30 billion US dollars in REGN-COV2 sales in Q4 2021, but does not mention a margin.

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T3: Does Regeneron publish the average and/or marginal costs of production?

Regeneron does not publish the average costs of production for REGEN-COV2.

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T4: Does Regeneron publish its production capacity?

Regeneron announced in August that by collaborating with Roche, the global supply of REGN-COV2 will become 3,5 times higher. In an earlier press release, the production capacity for treatment doses was estimated to be between 70.000 and 300.000 and the estimated production capacity for prevention doses between 420.000 and 1.300.000.

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T5: Does Regeneron publish the public subsidies it received during product development and/or testing?

Regeneron discloses part of the funding for REGEN-COV2 in a press release: ‘The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS’s Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C’.

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T6: Does Regeneron publish the text of licensing agreements?

No licensing agreements have been found online.

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T7: Does Regeneron register its clinical trials in public repositories?

Regeneron registers its clinical trials in clinicaltrials.gov.

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