Positive European Union (EU)-level scientific
opinion provides a pathway for more EU countries to access the
antibodies to treat COVID-19 before formal marketing authorizations
are granted
AbCellera (Nasdaq: ABCL) today announced that the European
Medicines Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP) has issued a positive scientific opinion for
bamlanivimab alone and bamlanivimab administered together with
etesevimab. The opinion advises bamlanivimab alone and bamlanivimab
administered together with etesevimab can be used for the treatment
of confirmed COVID-19 in patients aged 12 years and older that do
not require supplemental oxygen for COVID-19 and who are at high
risk of progressing to severe COVID-19. The CHMP recommendation
provides a harmonized, EU-level opinion on the efficacy, quality,
and safety of the antibodies, which can be used by EU member states
when making decisions on the possible use of the therapies at a
national level prior to market authorization.
“Bamlanivimab has been used to treat hundreds of thousands of
patients globally, and its impact continues to grow as the use of
COVID-19 antibody therapies accelerates,” said Carl Hansen, Ph.D.,
CEO and President of AbCellera. “Several EU countries have
authorized bamlanivimab, and the EMA’s CHMP recommendation provides
a mechanism for more EU countries to quickly access these
antibodies to treat patients in need.”
The EMA reviewed Phase 2 and Phase 3 results from Eli Lilly and
Company’s (Lilly) BLAZE-1 trial to support the CHMP opinion.
Results from BLAZE-1 demonstrated bamlanivimab alone reduced viral
load and rates of symptoms and also reduced hospitalization by
approximately 70%, and bamlanivimab and etesevimab together reduced
the risk of COVID-19 hospitalizations and death by 70% in
non-hospitalized high-risk patients with mild to moderate COVID-19.
Details regarding the CHMP opinion and Lilly’s plans to make
COVID-19 therapies broadly available to patients can be found
here.
Bamlanivimab has been authorized in more than 10 countries, and
bamlanivimab together with etesevimab received Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration
(FDA) on February 9, 2021. The EUA was followed by a $210 million
purchase agreement for Lilly to provide 100,000 doses of
bamlanivimab and etesevimab to the U.S. government through to March
31, 2021. The U.S. government will have the option to purchase up
to an additional 1,100,000 doses through November 25, 2021. This
purchase agreement is in addition to the 1,450,000 doses of
bamlanivimab alone that the US government previously committed to
purchase: to date, more than 1 million doses have been delivered,
and Lilly has agreed to deliver 450,000 additional doses by March
31, 2021. AbCellera is eligible to receive royalties in the low- to
mid-teens for aggregate sales below $125.0 million and mid-teens to
mid-twenties on aggregate sales above $125.0 million. Sales of
bamlanivimab in 2020 were $871 million.
About AbCellera’s Response to COVID-19
Bamlanivimab was developed from an antibody that was discovered
from the blood of a recovered COVID-19 patient using AbCellera’s
pandemic response platform, in partnership with the Vaccine
Research Center (VRC) at National Institute of Allergy and
Infectious Diseases (NIAID). Within one week of receiving the
sample, AbCellera screened over five million antibody-producing
cells to identify and isolate approximately 500 unique antibodies
that bind to SARS-CoV-2, the virus that causes COVID-19. The
binding antibodies were then tested by AbCellera, the VRC, and
Lilly to find those most effective in neutralizing the virus.
Bamlanivimab was selected as the lead candidate from this group of
antibodies, and was the first therapeutic candidate specifically
developed against SARS-CoV-2 to enter human clinical trials in
North America. Bamlanivimab was the first monoclonal antibody to
receive EUA from the FDA and is currently being assessed in several
clinical trials alone and together with other antibodies.
AbCellera’s pandemic response capabilities were developed over
the past three years as part of the Defense Advanced Research
Projects Agency (DARPA) Pandemic Prevention Platform (P3) program.
The goal of the P3 program is to establish a robust technology
platform for pandemic response capable of developing field-ready
medical countermeasures within 60 days of isolation of an unknown
viral pathogen. AbCellera’s ongoing efforts to respond to the
pandemic have identified more than 2,300 unique anti-SARS-CoV-2
human antibodies from multiple patient samples. These antibodies
are in various stages of testing by AbCellera and its partners.
About Bamlanivimab
Bamlanivimab is a recombinant, neutralizing human 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. 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 NIAID
VRC. 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 2/3
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 in ambulatory COVID-19
patients.
About AbCellera Biologics Inc.
AbCellera is a technology company that searches, decodes, and
analyzes natural immune systems to find antibodies that its
partners can develop into drugs to prevent and treat disease.
AbCellera partners with drug developers of all sizes, from large
pharmaceutical to small biotechnology companies, empowering them to
move quickly, reduce cost, and tackle the toughest problems in drug
development. For more information, visit www.abcellera.com
AbCellera Forward-looking Statements
This press release contains forward-looking statements,
including statements made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. The
forward-looking statements are based on management’s beliefs and
assumptions and on information currently available to management.
All statements contained in this release other than statements of
historical fact are forward-looking statements, including
statements regarding our ability to develop, commercialize and
achieve market acceptance of our current and planned products and
services, our research and development efforts, and other matters
regarding our business strategies, use of capital, results of
operations and financial position, and plans and objectives for
future operations.
In some cases, you can identify forward-looking statements by
the words “may,” “will,” “could,” “would,” “should,” “expect,”
“intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “ongoing” or the negative of
these terms or other comparable terminology, although not all
forward-looking statements contain these words. These statements
involve risks, uncertainties and other factors that may cause
actual results, levels of activity, performance, or achievements to
be materially different from the information expressed or implied
by these forward-looking statements. These risks, uncertainties and
other factors are described under "Risk Factors," "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" and elsewhere in the documents we file with the
Securities and Exchange Commission from time to time. We caution
you that forward-looking statements are based on a combination of
facts and factors currently known by us and our projections of the
future, about which we cannot be certain. As a result, the
forward-looking statements may not prove to be accurate. The
forward-looking statements in this press release represent our
views as of the date hereof. We undertake no obligation to update
any forward-looking statements for any reason, except as required
by law.
Source: AbCellera Biologics Inc.
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Media: Jessica Yingling, Ph.D.; media@abcellera.com,
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