DUBLIN, Sept. 29, 2021 /PRNewswire/ -- AiPharma
Global Holdings LLC ("AiPharma"), a private
biopharmaceutical research, development, and commercialization
company, and Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF)
("Appili"), a biopharmaceutical company focused
on drug development for infectious diseases, announced today a
strategic alliance to advance the global development of
Avigan®/Reeqonus™ (favipiravir), a broad-spectrum oral antiviral
currently being evaluated by Appili for the potential treatment and
prevention of COVID-19. AiPharma and Appili entered into a
strategic alliance agreement (the "Definitive
Agreement") to establish minority positions in each other's
businesses, further align their goals, and participate in each
other's respective economic interests.
Avigan®/Reeqonus™ (favipiravir) is a broad-spectrum anti-viral
in oral tablet form developed by Fujifilm. Avigan® has since been
authorized in 9 countries as a treatment for COVID-19. Countries
purchasing Avigan®/Reeqonus™ based on a national-level approval of
the therapy for the treatment of COVID-19 include Indonesia, Malaysia, Thailand, UAE and India. In a separate deal with Fujifilm, the
Japanese government has contracted to purchase a stockpile of over
65 million tablets. Today only Avigan® is approved for outpatient
(at home) treatment of mild to moderate COVID-19. Worldwide sales
of Avigan® have reached $190,000,000
in 2021, with at least 1.5M COVID-19
patients treated with favipiravir to date.
Dr. Alessandro Gadotti, Chief
Executive Officer at AiPharma said: "This is an exciting and
important partnership for us. Our work with Appili will have real
impact for people and communities around the world. 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 majorly 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. Our company was
established by a team of drug development, infectious disease, data
scientists and commercialization experts. We believe that this
expertise, paired with Appili's promising pipeline of specialty
therapeutics, will allow us to evolve into a global integrated
infectious disease healthcare company."
Under the equity share swap agreement, AiPharma will receive
that number of Class A common shares of Appili equal to 24% of the
issued and outstanding Appili shares immediately prior to the
agreement (calculated on a non-diluted basis). AiPharma has also
been granted certain investor rights, including pre-emptive rights,
consent rights and registration rights. Assuming no further equity
issuances, it is expected that AiPharma will hold approximately
19.4% of the issued and outstanding Appili Shares immediately
following closing.
In exchange, Appili will receive approximately 6% of the issued
and outstanding AiPharma shares (calculated on a non-diluted
basis).
The Toronto Stock Exchange has conditionally approved the
transactions, and the companies expect the transaction to be
completed in Q4 2021.
"COVID-19 continues to be an immense health threat with little
relief in sight. The world needs safe and efficient antivirals that
can help alleviate the threat of COVID-19, and I believe
Avigan®/Reeqonus™ has the potential to change the trajectory of
this pandemic," said Dr Armand
Balboni, M.D., Ph.D., Chief Executive Officer of Appili
Therapeutics. "This partnership will help us further streamline
activities and move quickly following PRESECO readout to key
clinical, regulatory, and commercial milestones."
The partnership between Appili and AiPharma will include the
formation of a joint scientific steering committee to further
coordinate global clinical and regulatory activities for
Avigan®/Reeqonus™ around the world. The steering committee will
include the following members:
- Dr. Armand Balboni; Chief
Executive Officer, Appili
- Dr. Yoav Golan; Chief Medical
Officer, Appili
- Dr. Alessandro Gadotti; Chief
Executive Officer, AiPharma
- Dr. Richard Kaszynski; Chief
Medical Officer, AiPharma
Additional Early Warning Disclosures of
AiPharma[1][2]
Pursuant to the terms of the Definitive Agreement, AiPharma has
agreed to subscribe for and purchase (the "Investment")
15,079,709 common shares of the Appili ("Appili Shares"), in
consideration for the issuance of shares of AiPharma, representing
approximately 6% interest in AiPharma as at September 28, 2021, with a value, based on the
closing price of Appili's shares on the Toronto Stock Exchange on
September 28, 2021, of approximately
C$15.3 million.
Immediately prior to the Investment, AiPharma, its affiliates
and joint actors owned no voting or equity securities in the
capital of Appili. Upon closing of the Investment, AiPharma and its
affiliates will own 15,079,709 Appili Shares, representing
approximately 19.4% of the currently outstanding Appili Shares, on
a non-diluted basis. When acquired, the Appili Shares will be held
by AiPharma for investment purposes and in furtherance of the
strategic alliance of Appili and AiPharma on the potential joint
development and commercialization of favipiravir and all other
molecules of Appili's portfolio, as is further provided for in the
Definitive Agreement. Depending on market conditions and other
factors, including AiPharma's business and financial condition,
AiPharma or its affiliates may acquire additional securities of
Appili or dispose of some or all of the securities of Appili that
it owns at such time.
This news release is issued under the early warning provisions
of Canadian securities legislation. An early warning report with
additional information in respect of the foregoing matters will be
filed and made available on the System for Electronic Document
Analysis and Review (SEDAR) at www.sedar.com under Appili's
profile. AiPharma is a limited liability company organized under
the laws of the State of Delaware.
AiPharma's address is One JLT (14th Floor), Jumeriah Lakes Towers,
Dubai, United Arab Emirates, PO
Box 103805. To obtain a copy of this report, you may also contact
Mr. John White (General Counsel,
AiPharma) at +971 58 554 8666.
For further information please contact:
Aoife Van
Wolvelaere, Edelman
Aipharmaglobal@edelman.com
Mary O'Brien, AiPharma
mary@aipharmalab.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 Appili Therapeutics
Appili Therapeutics is an
infectious disease biopharmaceutical company that is purposefully
built, portfolio-driven, and people-focused to fulfill its mission
of solving life-threatening infections. By systematically
identifying urgent infections with unmet needs, Appili's goal is to
strategically develop a pipeline of novel therapies to prevent
deaths and improve lives. As part of a global consortium, Appili is
sponsoring late-stage clinical trials evaluating the antiviral
Avigan/Reeqonus for the worldwide treatment and prevention of
COVID-19. The Company is also advancing a diverse range of
anti-infectives, including a broad-spectrum antifungal, a vaccine
candidate to eliminate a serious biological weapon threat, and two
novel antibiotic programs. Led by a proven management team, Appili
is at the epicenter of the global fight against infection. For more
information, visit www.AppiliTherapeutics.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.
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SOURCE AiPharma Global Holdings LLC
