Item 8.01 Other Events.
Sotrovimab (VIR-7831) Emergency Use Authorization
On May 26, 2021, Vir Biotechnology, Inc. (the "Company") and GlaxoSmithKline plc
("GSK") issued a press release announcing that the U.S. Food and Drug
Administration ("FDA") granted an Emergency Use Authorization ("EUA") for
sotrovimab (previously VIR-7831), an investigational single-dose monoclonal
antibody, for the treatment of mild-to-moderate COVID-19 in adults and pediatric
patients (12 years of age and older weighing at least 40 kg) with positive
results of direct SARS-CoV-2 viral testing, and who are at high risk for
progression to severe COVID-19, including hospitalization or death.
Sotrovimab has been granted an EUA by the FDA to facilitate the availability and
use of this investigational monoclonal antibody for the treatment of COVID-19 in
the United States while the pandemic remains a public health emergency.
Sotrovimab is continuing to be studied in ongoing clinical trials. An analysis
of safety and efficacy data at day 29 for the full population from the COMET-ICE
trial is expected as early as the first half of 2021. GSK and the Company plan
to submit a Biologics License Application to the FDA in the second half of 2021.
The EUA was granted to sotrovimab based on an interim analysis of efficacy and
safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy
Trial - Intent to Care Early) trial in high-risk adult outpatients, which was
stopped early by an independent data monitoring committee in March 2021 due to
evidence of profound clinical efficacy. As previously announced, interim study
results demonstrated an 85% (p=0.002) reduction in hospitalization for more than
24 hours or death in those receiving sotrovimab compared to placebo, the primary
endpoint of the trial. The most common adverse events observed in the sotrovimab
treatment group in COMET-ICE were rash (2%) and diarrhea (1%), all of which were
Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events
were reported at a higher rate with sotrovimab compared to placebo. The EUA
includes a warning for hypersensitivity including anaphylaxis and
infusion-related reactions.
Sotrovimab targets a conserved epitope of the spike protein that is less likely
to mutate over time. The EUA submission also included data from published in
vitro studies, which demonstrated that sotrovimab maintains activity against all
known circulating variants of concern, including the variants from Brazil (P.1),
California (B.1.427/B.1.429), India (B.1.617), New York (B.1.526), South Africa
(B.1.351) and the UK (B.1.1.7). GSK and the Company will continue to evaluate
the ability of sotrovimab to maintain activity against new and emerging
variants. The clinical impact of these in vitro variant data is not yet known.
Data collection and analysis is still ongoing. GSK and the Company are working
to make sotrovimab available to U.S. patients in the coming weeks with the
intent that all appropriate patients will have access to it, with little to no
out-of-pocket costs. GSK and the Company are actively working with government
agencies around the world to make sotrovimab available to patients in need of
treatment.
A copy of the press release is attached hereto as Exhibit 99.1 is being
furnished and shall not be deemed "filed" for the purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise
subject to the liabilities of that section, nor shall it be deemed incorporated
by reference into any filing made by the Company under the Securities Act of
1933, as amended, or the Exchange Act, except as shall be expressly set forth by
specific reference in such a filing.
Updated Corporate Presentation
On May 26, 2021, the Company posted an updated corporate presentation to its
website. A copy of the presentation is attached as Exhibit 99.2.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Words such as
"may," "will," "plan," "potential," "aim," "promising" and similar expressions
(as well as other words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements. These
forward-looking statements are based on the Company's expectations and
assumptions as of the date of this Current Report on Form 8-K. Forward-looking
statements contained in this Current Report on Form 8-K include, but are not
limited to, statements regarding the timing and availability of sotrovimab to
providers and patients, the timing and availability of clinical data, program
updates and data disclosures related to sotrovimab, the ability of sotrovimab
and VIR-7832 to treat and/or prevent COVID-19, the potential of sotrovimab in
the hospitalized population, the ability of sotrovimab to neutralize the
SARS-CoV-2 live virus, the ability of sotrovimab to maintain activity against
all known variants of concern, including the variant from India, and other
potential pandemics, statements related to the planned full analysis of the
COMET-ICE trial, and statements related to regulatory authorizations and
approvals, including plans and discussions with the FDA, EMA and other global
regulators. Many factors may cause differences between current expectations and
actual results, including unexpected safety or efficacy data observed during
preclinical or clinical studies, challenges in the treatment of hospitalized
patients, difficulties in collaborating with other companies or government
agencies, challenges in accessing manufacturing capacity, successful development
and/or commercialization of alternative product candidates by the
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Company's competitors, changes in expected or existing competition, delays in or
disruptions to the Company's business or clinical trials due to the COVID-19
pandemic, geopolitical changes or other external factors, and unexpected
litigation or other disputes. Other factors that may cause actual results to
differ from those expressed or implied in the forward-looking statements in this
press release are discussed in the Company's filings with the U.S. Securities
and Exchange Commission, including the section titled "Risk Factors" contained
therein. Except as required by law, the Company assumes no obligation to update
any forward-looking statements contained herein to reflect any change in
expectations, even as new information becomes available.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No. Description
99.1 Press Release of the Company and GSK, dated May 26, 2021.
99.2 Presentation, dated May 26, 2021
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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