Therapeutic:
Baricitinib (Olumiant)
&
Therapeutic:
Bamlanivimab & Etesevimab (LyCoV555)
&
Therapeutic:
Bebtelovimab (LyCoV-1404)
Eli Lilly Bariticinib (Olumiant) Summary Scorecard
| A: Commitments and Accountability | Score | C: International cooperation | Score |
| A1 The company publishes a global access plan for its product |  | C1 The company commits to C-TAP or MPP |  |
| A2 The company commits to comply with human rights standards in relation to product development and marketing | | C2 The company commits to not enforcing the exclusive rights of Covid-19 related patents | |
| C3 The company supplies to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator | |
||
| C4 The company agrees to license its Covid-19 medical products to other companies |  |
||
| E: Equality, non-discrimination & equity | Score | T: Transparency | Score |
| E1 The company makes the active ingredient available on reasonable ground. [Only for therapeutics] | | T1 The company publishes its R&D costs. | |
| E2 The company commits to full technology transfer to other manufacturers | | T2 The company publishes its profit margin. | |
| E3 The company commits to non-profit, ‘fair’, or differential pricing | | T3 The company publishes the average and/or marginal costs of production. | |
| E4 The company equitably distributes supplies globally. [Only applies to vaccines] | T4 The company publishes its production capacity. | |
|
| E5 The company does not seek protection beyond the minimum criteria in TRIPS, or enforces TRIPS+ measures [where applicable] |  | T5 The company publishes the public subsidies it received during product development and/or testing. | |
| E6 The company agrees to waive exclusive rights in regulatory test data [where applicable]. | | T6 The company publishes the text of licensing agreements. | |
| T7 The company registers its clinical trials in public repositories. | |
Eli Lilly - Baricitinib (Olumiant) Detailed Evaluation
Explore the results of PAF’s research into Eli Lilly’s behaviour. Each section is given an overall score; individual criteria are also scored (see icon following the criteria heading). Click on the ‘+’ sign next to each entry to expand and learn more.
A: Commitments and Accountability
Overall score:
A1 The company publishes a global access plan for its product
- General commitment to equitable access to medicines in LMICs
- Principles of Covid-19 antibody therapy pricing and access, but not specifically for Baricitinib
- Score:
A2 The company commits to comply with human rights standards in relation to product development and marketing
- No commitment to comply with human rights.
- Score:
C: International Cooperation
Overall score:
C1 The company commits to C-TAP or MPP
- No commitment to a responsible licensing mechanism
- Score:
C2 The company commits to not enforcing the exclusive rights of Covid-19 related patents
No commitment not to enforce patents: ‘Eli Lilly [has] filed and obtained patents widely, including in countries hit hard by the pandemic, such as Brazil, Russia, South Africa and Indonesia. Where patents are granted, the monopoly does not expire until 2029 and could even persist longer because of patent-term extensions’.
States on website: Olumiant is patent-protected in the USA until 2030; in Europe until 2029 and Japan until 2033
Score:
C3 The company supplies to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator
- No
- Score:
C4 The company agrees to license its Covid-19 medical products to other companies
- Yes, has signed deals with Indian generic manufacturers for royalty-free voluntary licensing agreements (Cipla, Natco pharma, Doctor Reddy’s, Sun Pharma, Lupin, Torrent and BDR)
- Score:
E: Equality, non-discrimination & equity
Overall score:
E1 The company makes the active ingredient available on reasonable ground
- No evidence that Eli Lilly makes the API available to other manufacturers (there is only one supplier of the generic ingredient Baricitinib)
- Score:
E2 The company commits to full technology transfer to other manufacturers
- Non-exclusive licensing agreements signed with Indian manufacturers but no evidence of full technology transfer
- Score:
E3 The company commits to non-profit or ‘fair’ pricing
- Baricitinib approved for other indications: generic versions already available in India and Bangladesh for nearly 400 times less than what Eli Lilly charges (2326USD per course of treatment vs 5.50USD in India)
- Score:
E4 The company equitably distributes supplies globally. [Only applies to vaccines]
[Only applies to vaccines]E5 The company does not seek protection beyond the minimum criteria in TRIPS, or enforces TRIPS+ measures [where applicable]
- No information.
- Score:
E6 The company agrees to waive exclusive rights in regulatory test data [where applicable]
- No information.
- Score:
T: Transparency
Overall score:
T1 The company publishes its R&D costs
- Publishes overall R&D costs for the year 2021, but not specific to Olumiant.
- Score:
T2 The company publishes its profit margin
- Q3 2021 financial report declares 1.425 billion USD revenue from Covid-19 therapies (Q3 2021 report), and that Olumiant generated 406.9 million USD (compared to 162 in 2020): “for the full year of 2021, Olumiant generated worldwide revenue of 1.115 billion USD, an increase of 75% compared with the full year of 2020. US revenue was 324.1 million USD, an increase of 260.3 million USD.”
- Score:
T3 The company publishes the average and/or marginal costs of production
- Does not publish the costs of producing Baricitinib
- Score:
T4 The company publishes its production capacity
- Not found
- Score:
T5 The company publishes the public subsidies it received during product development and/or testing
- “The Company has self-funded the research, development and manufacturing costs for its potential COVID-19 antibody treatments and has not accepted money from governments or accepted other public financial support in connection with its efforts to produce potential COVID-19 antibody treatments. The Company has already disclosed this fact publicly, including in its press release (the “Principles Press Release”) announcing the Company’s “Principles of COVID-19 Antibody Therapy Pricing and Access” (the “Principles”) and on the Company’s website dedicated to COVID-19 disclosure.
- Not specific to Baricitinib but for antibody treatments in general
- Score:
T6 The company publishes the text of licensing agreements
- No licensing agreement texts are published.
- Score:
T7 The company registers its clinical trials in public repositories
- Yes
- Score:
Eli Lilly Bamlanivimab & Etesevimab (LyCoV-555) Summary Scorecard
| A: Commitments and Accountability | Score | C: International cooperation | Score |
| A1 The company publishes a global access plan for its product | | C1 The company commits to C-TAP or MPP | |
| A2 The company commits to comply with human rights standards in relation to product development and marketing | | C2 The company commits to not enforcing the exclusive rights of Covid-19 related patents | |
| C3 The company supplies to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator | |
||
| C4 The company agrees to license its Covid-19 medical products to other companies | |
||
| E: Equality, non-discrimination & equity | Score | T: Transparency | Score |
| E1 The company makes the active ingredient available on reasonable ground. [Only for therapeutics] | | T1 The company publishes its R&D costs. | |
| E2 The company commits to full technology transfer to other manufacturers | | T2 The company publishes its profit margin. | |
| E3 The company commits to non-profit, ‘fair’, or differential pricing | | T3 The company publishes the average and/or marginal costs of production. | |
| E4 The company equitably distributes supplies globally. [Only applies to vaccines] | T4 The company publishes its production capacity. | |
|
| E5 The company does not seek protection beyond the minimum criteria in TRIPS, or enforces TRIPS+ measures [where applicable] | | T5 The company publishes the public subsidies it received during product development and/or testing. | |
| E6 The company agrees to waive exclusive rights in regulatory test data [where applicable]. | | T6 The company publishes the text of licensing agreements. | |
| T7 The company registers its clinical trials in public repositories. | |
Eli Lilly - Bamlanivimab & Etesevimab (LyCoV-555) Detailed Evaluation
Explore the results of PAF’s research into Eli Lilly’s behaviour. Each section is given an overall score; individual criteria are also scored (see icon following the criteria heading). Click on the ‘+’ sign next to each entry to expand and learn more.
A: Commitments and Accountability
Overall score:
A1 The company publishes a global access plan for its product
- General commitment to equitable access to medicines in LMICs
- Principles of Covid-19 antibody therapy pricing and access, but not specifically for Baricitinib
- Score:
A2 The company commits to comply with human rights standards in relation to product development and marketing
- No commitment to comply with human rights.
- Score:
C: International Cooperation
Overall score:
C1 The company commits to C-TAP or MPP
- No commitment to a responsible licensing mechanism
- Score:
C2 The company commits to not enforcing the exclusive rights of Covid-19 related patents
- No commitment not to enforce patents
- Score:
C3 The company supplies to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator
- No
- Score:
C4 The company agrees to license its Covid-19 medical products to other companies
- No licensing agreements so far.
- Score:
E: Equality, non-discrimination & equity
Overall score:
E1 The company makes the active ingredient available on reasonable ground
- No evidence that Eli Lilly makes the API available to other manufacturers.
- Score:
E2 The company commits to full technology transfer to other manufacturers
- No technology transfer agreements.
- Score:
E3 The company commits to non-profit or ‘fair’ pricing
- “We will pursue tiered pricing arrangements for government purchases of our antibody therapies, based on the World Bank’s gross national income (GNI) per capita data. The pricing will be tiered based on countries’ ability to pay, with wealthy countries paying the same as one another, middle-income countries receiving a steep discount, and the poorest countries paying only marginal costs. We will continue our work with philanthropic organizations such as the Bill & Melinda Gates Foundation to make our antibody therapies available to these low- and middle-income countries, furthering our goal of reaching as many patients with unmet needs as we can, no matter where they live.
- While the specific pricing for our potential combination therapy is not yet available, Lilly will offer bamlanivimab monotherapy at $1,250 per vial to wealthy countries, if authorized by the country’s regulators.”
- Tiered pricing but not concretised yet
- Score:
E4 The company equitably distributes supplies globally. [Only applies to vaccines]
[Only applies to vaccines]E5 The company does not seek protection beyond the minimum criteria in TRIPS, or enforces TRIPS+ measures [where applicable]
- No information.
- Score:
E6 The company agrees to waive exclusive rights in regulatory test data [where applicable]
- No information.
- Score:
T: Transparency
Overall score:
T1 The company publishes its R&D costs
- Publishes overall R&D costs for the year 2021, but not specific to Bamlanivimab & Etesevimab.
- Score:
T2 The company publishes its profit margin
“We expect to produce a modest financial return for our investors by the end of 2021”
The company recognized worldwide revenue of $1.063 billion from COVID-19 antibodies during the quarter compared with $871.2 million in the fourth quarter of 2020.
No specific profit margin for Bamlanivimab & Etesevimab
- Score:
T3 The company publishes the average and/or marginal costs of production
- Does not publish the average and/or marginal costs of producing Bamlanivimab & Etesevimab.
- Score:
T4 The company publishes its production capacity
- 1 million doses by mid-2021.
- Score:
T5 The company publishes the public subsidies it received during product development and/or testing
- “We have self-funded the research, development and manufacturing costs for our potential COVID-19 treatments, not accepting money from governments” https://www.lilly.com/news/stories/dave-ricks-covid19-antibody-therapy-pricing-access
- But “Operation Warp Speed invested heavily in the treatment throughout its development” for Bamlanivimab – subsidized through Advance Purchase Agreements
- See HHS page
- Score:
T6 The company publishes the text of licensing agreements
- Not found.
- Score:
T7 The company registers its clinical trials in public repositories
- Registers clinical trials plus results in public clinical trial databases
- Score:
Eli Lilly Bebtelovimab (LyCoV-1404) Summary Scorecard
| A: Commitments and Accountability | Score | C: International cooperation | Score |
| A1 The company publishes a global access plan for its product | | C1 The company commits to C-TAP or MPP | |
| A2 The company commits to comply with human rights standards in relation to product development and marketing | | C2 The company commits to not enforcing the exclusive rights of Covid-19 related patents | |
| C3 The company supplies to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator | |
||
| C4 The company agrees to license its Covid-19 medical products to other companies | |
||
| E: Equality, non-discrimination & equity | Score | T: Transparency | Score |
| E1 The company makes the active ingredient available on reasonable ground. [Only for therapeutics] | | T1 The company publishes its R&D costs. | |
| E2 The company commits to full technology transfer to other manufacturers | | T2 The company publishes its profit margin. | |
| E3 The company commits to non-profit, ‘fair’, or differential pricing | | T3 The company publishes the average and/or marginal costs of production. | |
| E4 The company equitably distributes supplies globally. [Only applies to vaccines] | T4 The company publishes its production capacity. | |
|
| E5 The company does not seek protection beyond the minimum criteria in TRIPS, or enforces TRIPS+ measures [where applicable] | | T5 The company publishes the public subsidies it received during product development and/or testing. | |
| E6 The company agrees to waive exclusive rights in regulatory test data [where applicable]. | | T6 The company publishes the text of licensing agreements. | |
| T7 The company registers its clinical trials in public repositories. | |
Eli Lilly - Bebtelovimab (LyCoV-1404) Detailed Evaluation
Explore the results of PAF’s research into Eli Lilly’s behaviour. Each section is given an overall score; individual criteria are also scored (see icon following the criteria heading). Click on the ‘+’ sign next to each entry to expand and learn more.
A: Commitments and Accountability
Overall score:
A1 The company publishes a global access plan for its product
- General commitment to equitable access to medicines in LMICs
- Principles of Covid-19 antibody therapy pricing and access, but not specifically for Baricitinib
- Score:
A2 The company commits to comply with human rights standards in relation to product development and marketing
- No commitment to comply with human rights.
- Score:
C: International Cooperation
Overall score:
C1 The company commits to C-TAP or MPP
- No commitment to a responsible licensing mechanism
- Score:
C2 The company commits to not enforcing the exclusive rights of Covid-19 related patents
- No commitment not to enforce patents
- Score:
C3 The company supplies to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator
- No (received FDA approval very recently, 12th February 2022)
- Score:
C4 The company agrees to license its Covid-19 medical products to other companies
Bebtelovimab was developed under a research collaboration and license agreement with AbCellera. AbCellera discovered the antibody; Lilly has the rights to ‘develop and commercialize therapeutic products resulting from the collaboration’
No evidence of licensing to other companies so far.
- Score:
E: Equality, non-discrimination & equity
Overall score:
E1 The company makes the active ingredient available on reasonable ground
- No evidence that Eli Lilly makes the API available to other manufacturers.
- Score:
E2 The company commits to full technology transfer to other manufacturers
- No technology transfer agreements.
- Score:
E3 The company commits to non-profit or ‘fair’ pricing
- “We will pursue tiered pricing arrangements for government purchases of our antibody therapies, based on the World Bank’s gross national income (GNI) per capita data. The pricing will be tiered based on countries’ ability to pay, with wealthy countries paying the same as one another, middle-income countries receiving a steep discount, and the poorest countries paying only marginal costs. We will continue our work with philanthropic organizations such as the Bill & Melinda Gates Foundation to make our antibody therapies available to these low- and middle-income countries, furthering our goal of reaching as many patients with unmet needs as we can, no matter where they live.
- Bebtelovimab is not mentioned in this commitment, but it can be assumed that this will apply to all Eli Lilly’s neutralizing antibodies; however, there is no concrete evidence of this yet
So far, 600 000 doses of Bebtelovimab have been sold to the US government for at least 720M USD. No other orders have been placed.
- Score:
E4 The company equitably distributes supplies globally. [Only applies to vaccines]
[Only applies to vaccines]
E5 The company does not seek protection beyond the minimum criteria in TRIPS, or enforces TRIPS+ measures [where applicable]
- No information.
- Score:
E6 The company agrees to waive exclusive rights in regulatory test data [where applicable]
- No information.
- Score:
T: Transparency
Overall score:
T1 The company publishes its R&D costs
- Publishes overall R&D costs for the year 2021, but not specific to Bebtelovimab.
- Score:
T2 The company publishes its profit margin
“We expect to produce a modest financial return for our investors by the end of 2021”
The company recognized worldwide revenue of $1.063 billion from COVID-19 antibodies during the quarter compared with $871.2 million in the fourth quarter of 2020.
No specific profit margin for Bebtelovimab
- Score:
T3 The company publishes the average and/or marginal costs of production
- Does not publish the average and/or marginal costs of producing Bamlanivimab & Etesevimab.
- Score:
T4 The company publishes its production capacity
Deal for 600 000 doses to USG and option of 500 000 additional doses no later than July 2022
Doesn’t publish total production capacity
- Score:
T5 The company publishes the public subsidies it received during product development and/or testing
- “Lilly has licensed and developed bebtelovimab after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.”
- “We have self-funded the research, development and manufacturing costs for our potential COVID-19 treatments, not accepting money from governments”
- Score:
T6 The company publishes the text of licensing agreements
- Licensing agreement with the US government not published.
- Score:
T7 The company registers its clinical trials in public repositories
- Phase 2 trial results published: https://clinicaltrials.gov/ct2/show/NCT04634409
- Score: