Phase 3 clinical trial of Avigan/Reeqonus
for treatment of COVID-19 completed enrollment of more than 1,200
patients in the U.S., Mexico and Brazil with topline results
expected in less than 60 days
Aditxt, Inc. (“Aditxt”) (Nasdaq: ADTX), a biotech innovation
company with a mission to improve the health of the immune system,
today announced it has entered into a transaction agreement to
reach a definitive agreement by the end of November 2021 to acquire
a subsidiary (“AiPharma”) of AiPharma Global Holdings LLC
(“AiPharma Global”) which is to own all of the assets of AiPharma
Global, a company focused on discovering, developing and
commercializing antiviral therapies across a broad spectrum of
infectious diseases.
AiPharma Global is a biopharmaceutical company that holds
directly, or through its affiliates worldwide (excluding Japan),
exclusive rights to Avigan/Reeqonus/Qifenda and all formulations of
favipiravir, a broad spectrum oral antiviral drug that targets
COVID-19 and other infectious diseases. The binding agreement
follows Aditxt’s prior announcement on August 25, 2021 to acquire
the company and Aditxt’s funding of a bridge loan to AiPharma
Global in the amount of $6.5 million.
The acquisition, if completed, will form a business segment for
Aditxt that is focused on the monitoring and treatment of
infectious diseases. Key terms of the agreement include: an
increase in the amount of permitted borrowings under the secured
loan from Aditxt to AiPharma Global by $8.5 million resulting in
total availability of $15 million, as well as Aditxt issuing such
number of shares of common stock that yields 65% of the number of
Aditxt’s outstanding shares calculated as of September 30, 2021 to
be issued only upon closing of the transaction.
The acquisition is subject to confirmatory due diligence, entry
into a definitive agreement based on agreed terms and other closing
conditions, including regulatory, board, shareholder, and Nasdaq
approvals. There is no assurance that the aforementioned approvals
will be granted.
AiPharma acquisition highlights:
- Avigan has received full marketing authorization or emergency
use authorization in a number of markets as a treatment for
COVID-19 including Mexico, India, Indonesia, Thailand and Malaysia,
with many other countries buying the drug under compassionate use
programs including the United Kingdom, United Arab Emirates,
Greece, Hungary and Saudi Arabia.
- AiPharma Global generates revenues from worldwide sales outside
the U.S. and Canada of Avigan/Reeqonus through its 50% equity stake
in Global Response Aid (“GRA”). GRA is part of a consortium that
includes Appili Therapeutics (TSX: APLI; OTCQX: APLIF), Dr. Reddy’s
Laboratories (NYSE:RDY), Agility (KSE/DFM: AGLTY) and FUJIFILM
Toyama Chemical Co. Ltd, a subsidiary of FUJIFILM Holdings (FUJIY).
The consortium members work together to coordinate and accelerate
the worldwide development of Avigan/Reeqonus.
- Consortium partner Appili Therapeutics is running a global
Phase 3 trial evaluating Avigan/Reeqonus as an oral at-home therapy
for COVID-19 and recently announced completion of patient
enrollment with top line data expected in approximately 60
days.
- AiPharma Global has recently agreed to acquire a major stake in
Appili Therapeutics to strengthen its collaboration on the
development of favipiravir and other treatments for infectious
diseases. AiPharma Global expects to own 19.4% of the issued and
outstanding Appili shares following the closing of its transaction
expected Q4 2021.
- Favipiravir is a selective inhibitor of viral RNA-dependent RNA
polymerase (RdRP) with potent antiviral activity against
single-stranded RNA viruses, including coronaviruses.
Avigan/Reeqonus/Qifenda is uniquely positioned to address the
current COVID-19 pandemic and future viral outbreaks.
“The successful completion of this acquisition would accelerate
our commercialization plans in the infectious disease space and
would uniquely position Aditxt by combining our commercialized
AditxtScore™ for COVID-19 test with an at-home treatment for the
disease. While initially targeting COVID-19, our combined clinical
and commercial platform would potentially address unmet needs in
other viral indications,” stated Aditxt Co-Founder and CEO Amro
Albanna. ”We look forward to partnering with the team at AiPharma
and its consortium members.”
Dr. Alessandro Gadotti, CEO of AiPharma Group, commented, “We
believe that the combination of Aditxt and AiPharma is uniquely
positioned to address the key topics of the COVID-19 pandemic,
starting from monitoring of immune status and outpatient treatment
for the illness. In excess of 1.5 million patients have been
treated with our antiviral tablets. The strength of oral antiviral
treatments such as Avigan/Reeqonus in real terms is that they fight
COVID-19 in the community and not in hospitals - which can
significantly reduce pressures on healthcare systems. Our joint
product portfolio puts us on the front line in the fight against
COVID-19 and future pandemic preparedness.”
About Avigan/Reeqonus/Qifenda (favipiravir)
Avigan/Reeqonus/Qifenda (favipiravir) is a broad-spectrum
antiviral in oral tablet form developed by FUJIFILM Toyama Chemical
Co., Ltd. (FFTC). Following promising clinical studies, Russia,
Thailand, Indonesia, India and Malaysia approved favipiravir-based
antiviral medications for the emergency treatment of COVID-19.
Additional clinical trials for favipiravir in COVID-19 are
ongoing in the United States, China, India, and the United Kingdom.
Unlike most other interventions that researchers are evaluating in
the COVID-19 indication, favipiravir has already been thoroughly
studied in human trials outside of North America and has a known
safety profile, with over 3,000 subjects receiving at least one
dose of the drug in controlled clinical trials, and more than
30,000 people having received Avigan in Observational Studies. The
safety profile has been further confirmed by the hundreds of
thousands of patients that have received favipiravir during the
COVID-19 pandemics in the authorized countries. Favipiravir’s oral
tablet form may also provide advantages in the community setting
over other COVID-19 interventions, which often require injection or
intravenous administration.
Avigan is approved for manufacture and sale in Japan as an
anti-influenza virus drug and as a treatment and stockpile
countermeasure for pandemic influenza. The Japanese government has
contracted with Fujifilm to purchase a stockpile of over 65 million
tablets.
About Aditxt:
Aditxt is developing technologies focused on improving the
health of the immune system through immune monitoring and
reprogramming. Aditxt’s immune monitoring technology is designed to
provide a personalized comprehensive profile of the immune system.
Aditxt’s immune reprogramming technology is currently at the
pre-clinical stage and is designed to retrain the immune system to
induce tolerance with an objective of addressing rejection of
transplanted organs, autoimmune diseases, and allergies. For more
information, please visit: www.aditxt.com.
About AiPharma Global
AiPharma Global is a biopharmaceutical company focused on
discovering, developing, and commercializing oral therapies to
address the unmet medical needs of patients with life-threatening
viral diseases. Leveraging the Company’s deep understanding of
antiviral drug development, nucleotide chemistry, biology,
biochemistry, and virology, AiPharma Global has built a nucleotide
prodrug platform to develop novel product candidates to treat
single-stranded ribonucleic acid, or ssRNA, viruses, which are a
prevalent cause of severe viral diseases. Currently, AiPharma
Global is focused on the clinical and commercial development of
orally available, potent, and selective nucleotide prodrugs for
difficult-to-treat, life-threatening viral infections, including
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the
virus that causes COVID-19, dengue virus, hepatitis C virus (HCV)
and respiratory syncytial virus (RSV). AiPharma Global also holds
exclusive commercial rights for Avigan in Russia and China.
For more information, please visit www.aipharmalab.com.
Forward-Looking Statements
Certain statements in this press release constitute
“forward-looking statements” within the meaning of federal
securities laws. Forward-looking statements include statements
regarding the Company’s intentions, beliefs, projections, outlook,
analyses or current expectations concerning, among other things,
the Company’s ongoing and planned product and business development;
the Company’s intellectual property position; the Company’s ability
to develop commercial functions; expectations regarding product
launch and revenue; the Company’s results of operations, cash
needs, spending, financial condition, liquidity, prospects, growth
and strategies; the industry in which the Company operates; and the
trends that may affect the industry or the Company. Forward-looking
statements are not guarantees of future performance and actual
results may differ materially from those indicated by these
forward-looking statements as a result of various important
factors, as well as those risks more fully discussed in the section
titled “Risk Factors” in the Company’s most recent Annual Report on
Form 10-K, as well as discussions of potential risks,
uncertainties, and other important factors in the Company’s other
filings with the Securities and Exchange Commission. All such
statements speak only as of the date made, and the Company
undertakes no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20211005005730/en/
Media and Investor Relations Contact: Aditxt, Inc.
ir@aditxt.com
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