DUBAI, United Arab Emirates,
Oct. 5, 2021 /PRNewswire/
-- AiPharma Global Holdings LLC ("AiPharma") a
company focused on discovering, developing and commercializing
antiviral therapies across a broad spectrum of infectious diseases
today announced it has entered a binding agreement to sell all of
its assets through the sale of one of its wholly owned group
subsidaries, to Aditxt Inc. (Nasdaq: ADTX). Aditxt is a biotech
innovation company with a mission to improve the health of the
immune system.
AiPharma 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, a key
term toward completion of the acquisition, subject to certain
closing conditions.
The acquisition will form a business segment for Aditxt that is
focused on the prevention, treatment, and monitoring of infectious
diseases.
AiPharma business highlights:
- Avigan has received full marketing authorization or emergency
use authorisation 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 generates revenues from worldwide sales of
Avigan/Reeqonus through its 50% equity stake in the Global Response
Aid (GRA). Global sales of Avigan have reached in excess of
$150 million in 2021,
with at least 1.5 million COVID-19 patients treated with Avigan to
date.
- 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 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 within 45 days. Appili has
also planned a Phase 3 post-exposure prophylaxis study designed to
evaluate Avigan/Reeqonus for the prevention of COVID-19 when given
to asymptomatic individuals who have had direct exposure to an
infected person. Appili expects to initiate following successful
completion of the treatment study.
- AiPharma 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
is expected to own 19.4% of the issued and outstanding Appili
shares following the closing of its transaction expected Q4
2021.
- Avigan is approved for manufacture and sale in Japan as an anti-influenza virus drug.
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
now.
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.
"We have treated in excess of 1.5 million patients 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."
"The completion of this acquisition would position Aditxt
uniquely to prevent, treat, and monitor COVID-19 by combining our
commercialized AditxtScore COVID-19 test with a potential
prophylactic and at-home treatment for the disease. While initially
targeting COVID-19, our combined clinical and commercial platform
would address unmet needs in other viral
indications," stated Aditxt Co-Founder and CEO
Amro Albanna. "We are very
excited to work with the team at AiPharma and its consortium
partners. We look forward to reaching a definitive agreement
quickly by the end of October and closing this
transaction."
For further information please contact:
Aoife Van
Wolvelaere
AiPharmaGlobal@edelman.com
About AiPharma
AiPharma 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
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 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 also holds exclusive commercial rights for Avigan in
Russia and China.
For more information, please visit
www.aipharmalab.com.
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 Avigan/ Reeqonus
(favipiravir)
Avigan /Reeqonus(favipiravir) is
a broad-spectrum antiviral in oral tablet form developed by
FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in
Japan as a treatment and stockpile
countermeasure for pandemic influenza. Following promising clinical
studies, Russia, Thailand, Indonesia, India and Malaysia approved favipiravir-based antiviral
medications for the emergency treatment of COVID-19. In a
separate deal with Fujifilm, the Japanese government has contracted
to purchase a stockpile of over 65 million tablets.
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.
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.
Media and Investor Relations Contact:
Aditxt Investor Communications
ir@aditxt.com
For more information please email PR@aipharmalab.com or
adam@message-media.co.uk
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SOURCE AiPharma Global Holdings LLC