INDIANAPOLIS, Oct. 28, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today an initial agreement with the
U.S. government to supply 300,000 vials of bamlanivimab (LY-CoV555)
700 mg, an investigational neutralizing antibody, for $375 million. The U.S. government will accept the
vials of bamlanivimab if it is granted an Emergency Use
Authorization (EUA) by the U.S. Food and Drug Administration (FDA).
Lilly submitted a request for an EUA for bamlanivimab for the
treatment of mild to moderate COVID-19 in high-risk patients to the
FDA in early October. The initial agreement is for delivery over
the two months following an EUA and also provides the option for
the U.S. government to purchase up to an additional 650,000 vials
through June 30, 2021, under the same
terms as the base agreement and subject to agreement from Lilly,
product availability and the medical need in the U.S.
"Lilly has leveraged our deep scientific capability to fight
this pandemic and we are proud of our efforts to develop potential
medicines to combat COVID-19. Supply agreements with governments –
such as this one with the U.S. government to meet Operation Warp
Speed goals – are fundamental to enable the most widespread and
equitable access to our potential therapy," said David A. Ricks, Lilly's chairman and CEO. "The
U.S. is experiencing a surge in COVID-19 cases and associated
hospitalizations, and we believe bamlanivimab could be an important
therapeutic option that can bring value to the overall healthcare
system, as it has shown a potential benefit in clinical outcomes
with a reduction in viral load and rates of symptoms and
hospitalizations."
If an EUA is granted, the U.S. government has committed that
patients will have no out-of-pocket costs for the medicine,
although healthcare facilities may charge a fee for the product's
administration. The federal government, in partnership with state
health departments, is developing a government allocation program
for bamlanivimab. As part of this government program, Lilly is
partnering with Operation Warp Speed and a national distributor to
finalize distribution plans and shipping preparations, should an
EUA be granted. The intravenous administration of therapeutics to
patients with confirmed mild to moderate COVID-19 presents unique
challenges to the healthcare system. Lilly is also working closely
with Operation Warp Speed to assist U.S. federal and state agencies
in the identification and creation of options for locations where
patients can receive this medication that are accessible and
minimize infection transmission.
Lilly anticipates manufacturing up to one million doses of
bamlanivimab 700 mg by the end of 2020 – with 100,000 doses ready
to ship within days of authorization – for use around the world.
The supply of Lilly's antibody therapy is expected to increase
substantially beginning in Q1 2021, as additional manufacturing
resources come online throughout the year. Lilly has a robust,
global supply chain in place to produce bamlanivimab, with five
active pharmaceutical ingredients (API) manufacturing sites
worldwide. To ensure rapid access of this treatment to patients
around the world, Lilly has invested in large-scale manufacturing
of bamlanivimab at risk – even before data demonstrated its
potential to become a meaningful therapeutic option for
COVID-19.
Discussions with global regulators are ongoing. Global
allocation will be made based on Lilly's guiding principles that
aim to ensure access for patients with high unmet need, no matter
where they live. Read more about Lilly's global pricing and access
principles for its antibody therapies at lilly.com.
"We are also partnering with governments and philanthropic
organizations around the world to ensure a fair and transparent
allocation of the limited supply of our antibody therapies to those
who need it most, based on a global methodology using data from
trusted research centers," Ricks continued.
About bamlanivimab
Bamlanivimab is a potent, neutralizing IgG1 monoclonal antibody
(mAb) directed against the spike protein of SARS-CoV-2. It is
designed to block viral attachment and entry into human cells, thus
neutralizing the virus, potentially preventing and treating
COVID-19. Bamlanivimab emerged from the collaboration between Lilly
and AbCellera to create antibody therapies for the prevention and
treatment of COVID-19. Lilly scientists rapidly developed the
antibody in less than three months after it was discovered by
AbCellera and the scientists at the National Institute of Allergy
and Infectious Diseases (NIAID) Vaccine Research Center. It was
identified from a blood sample taken from one of the first U.S.
patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of
bamlanivimab in hospitalized patients with COVID-19
(NCT04411628). A Phase 2 study in people recently diagnosed
with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is
ongoing. A Phase 3 study of bamlanivimab for the prevention of
COVID-19 in residents and staff at long-term care facilities
(BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab
is being tested in the National Institutes of Health-led ACTIV-2
study of ambulatory COVID-19 patients.
Data from the BLAZE-1 study show bamlanivimab may be effective
in treating COVID-19 by reducing viral load, symptoms and the risk
of hospitalization in patients recently diagnosed with mild to
moderate COVID-19. In the BLAZE-1 trial, rates and types of adverse
events were similar between bamlanivimab and placebo, with the
majority being mild to moderate in severity and with no
drug-related serious adverse events reported thus far. In other
bamlanivimab studies, there have been isolated drug-related
infusion reactions or hypersensitivity that were generally mild
(two reported as serious infusion reactions, both patients
recovered).
About Lilly's COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical
expertise to attack the coronavirus pandemic around the world.
Existing Lilly medicines are now being studied to understand their
potential in treating complications of COVID-19, and the company is
collaborating with partner companies to discover novel antibody
treatments for COVID-19. Lilly is testing both single antibody
therapy as well as combinations of antibodies as potential
therapeutics for COVID-19. Click here for media resources
related to Lilly's COVID-19 efforts.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with
discovery to create medicines that make life better for people
around the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring life-changing
medicines to those who need them, improve the understanding and
management of disease, and give back to communities through
philanthropy and volunteerism. To learn more about Lilly,
please visit us at www.lilly.com and www.lilly.com/news. P-LLY
Lilly Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about bamlanivimab (LY-CoV555) as a potential
treatment for patients with or at risk of infection from
COVID-19, as well as its supply, cost and potential regulatory
approval. This press release reflects Lilly's current beliefs.
However, as with any such undertaking, there are substantial risks
and uncertainties in the process of drug development and
commercialization. Among other things, there can be no
guarantee that studies will complete as planned, that future
study results will be consistent with the results to date, that
bamlanivimab will prove to be a safe and effective treatment or
preventative for COVID-19, that bamlanivimab will receive
regulatory approvals or authorizations, or that we can provide an
adequate supply of bamlanivimab in all circumstances. For a
further discussion of these and other risks and uncertainties that
could cause actual results to differ from Lilly's expectations,
please see Lilly's most recent Forms 10-K and 10-Q filed with the
U.S. Securities and Exchange Commission. Lilly undertakes no duty
to update forward-looking statements.
Refer
to:
Molly McCully;
mccully_molly@lilly.com; 317-478-5423 (Media)
Kevin Hern; hern_kevin_r@lilly.com;
317-277-1838 (Investors)
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