PR85757

DUBAI, UAE, September 23, 2020, /PRNewswire=KYODO JBN/--

Completed Phase 3 clinical study paves way for approval request

Healthcare solutions provider Global Response Aid (GRA) and Dr. Reddy's

Laboratories (NYSE: RDY) announced that the anti-viral drug Avigan(R) produced

promising results in a single-blinded, placebo-controlled Phase 3 clinical

study conducted in Japan with the sponsorship of FujiFilm Toyama Chemical.

Patients who received Avigan(R) recovered from COVID-19 symptoms 2.8 days

earlier, on average, compared with the control group. Analysis showed patients

had a statistically significant higher probability to recover when administered

Avigan(R) compared with the patients not receiving the drug.

The study involved 156 hospitalized patients showing COVID-19 induced

pneumonia, and divided in two groups or "arms." Patients in the first arm

received Avigan(R). Patients in the second arm received a placebo looking

identical to the drug. A statistically significant percentage of the patients

in the group receiving Avigan(R) had a rapid reduction in viral loads.

The study aimed to measure recovery from pneumonia and COVID-19 symptoms. It

monitored patients' temperature, oxygen saturation and CT scan imaging of the

lungs. Time-to-alleviation of the symptoms was measured between the first

administration of the drug (or placebo) and the moment when SARS-COV-2 induced

symptoms became undetectable.

Shortening recovery time lowers the risk of complications in patients and,

importantly, significantly reduces the risk that a patient will spread the

virus. The latest results open the possibility of treating patients with mild

or moderate cases of COVID-19 in outpatient settings, which also could help

slow the spread of the pandemic.

Avigan(R), which contains the active ingredient Favipiravir, was developed by

FujiFilm Toyama Chemical in the 1990s as an anti-influenza drug. GRA, Dr.

Reddy's Laboratories, and FujiFilm Toyama recently entered a global licensing

agreement covering the production, marketing and distribution of Avigan(R).

Results of the Japan trial suggest the effectiveness of Avigan(R) as a

treatment to prevent COVID-19 patients from progressing from mild to more

severe or critical clinical stages of the disease, and to accelerate recovery

from COVID-19 symptoms.  

GRA CEO Mitch Wilson said the FujiFilm Toyama study represents a breakthrough

in the fight against COVID-19, and opens the way for approval of Avigan(R) as a

COVID-19 treatment in Japan. The drug is already approved in India, Russia,

Indonesia and other countries around the world.

"The findings from this university-led study are the proof we all need to

tackle this pandemic," Wilson said. "We are actively working with regulators in

order to speed up the approval in major markets. Because Avigan(R) is

manufactured in pill form the drug can be self-administered from home, which

reduces patient load in hospitals and on medical staff. Furthermore Avigan(R)

does not require refrigerated transport or storage making it much easier to

quickly distribute the drug to countries and markets with limited cold storage

infrastructure"

Avigan(R) is the subject of clinical trials in COVID-19 patients in several

countries. It was used to treat COVID-19 patients in studies in China's Hubei

province, led by the China-Japan Friendship Hospital. It is undergoing testing

in the United States in a multi-site Phase 2 study involving initially hospitalized

patients, a trial sponsored by FujiFilm Toyama Chemical. It also is the subject of

an investigator-initiated Phase 2 study in subjects with mild or asymptomatic

COVID-19 being conducted by the Stanford University School of Medicine.

Avigan(R) Tablet was approved for manufacture and sale in Japan in 2014 as an

influenza anti-viral drug. The drug is to be considered for use only when there

is an outbreak of novel or re-emerging influenza virus infections in which

other influenza anti-viral drugs are either not effective or insufficiently

effective, and the Japanese government decides to use the drug as a

countermeasure against such influenza viruses.

GRA is a Dubai-based company established by global logistics leader Agility

(KSE: AGLTY) and AiPHARMA a biotechnology company to procure and develop

certified diagnostic, testing and protective products and services used in the

detection, treatment and prevention of COVID-19 and other public health threats.

About Global Response Aid (GRA)

Global Response Aid, based in Dubai, provides solutions to public health

challenges. GRA was established by global logistics leader Agility and AiPHARMA

a biotechnology company to procure and develop certified diagnostic, testing

and protective products and services used in the detection, treatment and

prevention of COVID-19 and other public health threats. GRA works with trusted

manufacturers to source safe, effective products for governments, health

authorities and public institutions; frontline medical facilities; NGOs; and

companies looking to safeguard workers and workplaces. GRA-sourced products

include ventilators, thermal detection equipment, thermometers, masks, goggles,

protective suits, nitrile gloves, cleaning and sanitation supplies, and

point-of-care test kits. GRA's mobile phone app helps stop the spread of

viruses through the use of community-driven contact tracing and alerts. GRA

also deploys Mobile Diagnostic Testing Vehicles and trained teams that perform

COVID-19 testing at schools and workplaces.

For more information, please visit https://globalresponseaid.com/ 

About FUJIFILM

FUJIFILM Toyama Chemical Co., Ltd. conducts the research, development,

manufacture, and sales of radiopharmaceuticals and small molecule

pharmaceutical products. Under close cooperation with FUJIFILM Corporation, it

aims to develop innovative diagnostic and therapeutic radiopharmaceuticals, as

well as therapeutic drugs having unique mechanisms of action in the fields of

"oncology," "central nervous system diseases," and "infectious diseases" where

significant unmet medical needs still exist. It also works to develop new

medicines utilizing drug delivery system (DDS) technologies, designed to

deliver the required amount of a drug in a timely manner to the specific body

area. By exploring synergy with in vitro diagnostic devices and reagents owned

by Fujifilm group companies, the company will expand its offering of

comprehensive solutions from diagnosis to treatment. FUJIFILM Toyama Chemical

have expanded its business areas to medical IoT solutions including a system to

support pharmacists' drug dispensing auditing work, and a transportation device

that enables strict temperature control suited for blood products, cells and

tissue used for regenerative medicine. Through the development and supply of

high-quality, high added-value new drugs and products that support the clinical

settings, FUJIFILM Toyama Chemical strives to solve various social challenges,

and contribute to improving medicine and enhancing the quality of life.

For more information, please visit http://fftc.fujifilm.co.jp/en/

About Dr. Reddy's

About Dr. Reddy's: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY,

NYSE: RDY) is an integrated pharmaceutical company, committed to providing

affordable and innovative medicines for healthier lives. Through its three

businesses - Pharmaceutical Services & Active Ingredients, Global Generics and

Proprietary Products – Dr. Reddy's offers a portfolio of products and services

including APIs, custom pharmaceutical services, generics, biosimilars and

differentiated formulations. Our major therapeutic areas of focus are

gastrointestinal, cardiovascular, diabetology, oncology, pain management and

dermatology. Dr. Reddy's operates in markets across the globe. Our major

markets include – USA, India, Russia & CIS countries, and Europe.

For more information, log on to: www.drreddys.com      

About AiPharma

AiPHARMA is an early-stage biotechnology company with regional offices in

Boston, Dubai, Tokyo, Singapore and Hong Kong. Aipharma take a highly

interdisciplinary approach to science, with services building upon work from

leading academic labs in biophysics and algorithmic design that enables the

acceleration of life science research and development in the pursuit of

improved human health. The company leverages machine learning and automation to

build platforms for science at scale. With its foundations in engineering

disciplines, the company's platform technologies vertically integrate

proprietary hardware, software, bioinformatics, chemistries, and molecular

biology to advance basic research, target validation, and clinical trials.

For more information, log on to: www.aipharmalab.com

About Agility

Agility is a global logistics company with $5.2 billion in annual revenue and

26,000+ employees in more than 100 countries. It is one of the world's top

freight forwarding and contract logistics providers, and a leader and investor

in technology to enhance supply chain efficiency. Agility is a pioneer in

emerging markets and one of the largest private owners and developers of

warehousing and light industrial parks in the Middle East, Africa and Asia.

Agility's subsidiary companies offer fuel logistics, airport services,

commercial real estate and facilities management, customs digitization, and

remote infrastructure services.

For more information about Agility, visit www.agility.com 

Twitter: twitter.com/agility    

LinkedIn: linkedin.com/company/agility   

YouTube: youtube.com/user/agilitycorp 

Forward Looking Statement -- This news release includes forward-looking

statements, within the meaning of the Private Securities Litigation Reform Act

of 1995 that are subject to risks, uncertainties and other factors, including

the possibility of unfavorable results from clinical trials involving Avigan®

and the possibility that we may be unable to complete one or more of such

trials in the currently anticipated timelines or at all. Further, it is

possible that GRA and Dr. Reddy's may make a strategic decision to discontinue

development of Avigan®. As a result, Avigan® may never be successfully

commercialized. All statements other than statements of historical fact are

statements that could be deemed forward-looking statements. These risks,

uncertainties and other factors could cause actual results to differ materially

from those referred to in the forward-looking statements. The reader is

cautioned not to rely on these forward- looking statements. These and other

risks are described in detail in Dr. Reddy's Annual Report on Form 10-K for the

year ended December 31, 2019, as filed with the U.S. Securities and Exchange

Commission. All forward-looking statements are based on information currently

available to GRA, and GRA assumes no obligation to update any such

forward-looking statements.

SOURCE: Agility