Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, along with its subsidiaries together referred to as “Dr.
Reddy’s”), Appili Therapeutics (TSX: APLI, OTCQX: APLIF) and Global
Response Aid FZCO (GRA) today announced that Dr. Reddy’s Canada has
filed an application on behalf of the consortium for REEQONUS™
(favipiravir) Tablets for the acute treatment of mild to moderate
COVID-19 adult patients under Health Canada’s Interim Order
Respecting the Importation, Sale and Advertising of Drugs for Use
in Relation to COVID-19. REEQONUS™ is also known as Avigan®
(favipiravir) Tablets, developed by FUJIFILM Toyama Chemical Co.,
Ltd.
“We are pleased to work with our partners at GRA and Appili to
be the first in Canada to file an application for oral solid
tablets for COVID-19 treatment under Health Canada’s Interim
Order,” says Vinod Ramachandran, Ph.D., Vice President and General
Manager, Dr. Reddy’s Laboratories Canada Inc. “Dr. Reddy’s is
working closely with Health Canada for an expedited review of the
drug application, as speed to market is essential in these
unprecedented times. If approved, we look forward to launching this
important product soon to benefit the lives and health of COVID-19
patients in Canada.”
“Reaching patients early in the infection to prevent possible
progression into more serious forms of this disease remains a
critical unmet need in the COVID-19 treatment landscape,” says Dr.
Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Our
role remains to design rigorous trials to obtain the data that
identify COVID-19 patients that may benefit from REEQONUS™. We look
forward to working with our partners in providing information to
Health Canada with the goal of advancing this important innovation
for patients.”
“Our outreach to Canada is a part of our global efforts to play
an active role in addressing the COVID-19 situation. The filing is
a testimony to our commitment of bringing a potential solution to
COVID-19 for the Canadian population,” says Mitch Wilson, Chief
Executive Officer of GRA.
In September, the Interim Order Respecting the Importation, Sale
and Advertising of Drugs for use in Relation to COVID-19 was signed
by the Minister of Health in Canada to create a new authorization
pathway that will help expedite the authorization of drugs and
vaccines for COVID-19. According to Health Canada, REEQONUS™
(favipiravir) Tablets are the first oral solid dosage form
submitted under the Interim Order.
Avigan® is a trademark of FUJIFILM Toyama Chemical Co., Ltd.
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.
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on
the management’s current views and assumptions and involve known or
unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those expressed or
implied in such statements. In addition to statements which are
forward-looking by reason of context, the words "may", "will",
"should", "expects", "plans", "intends", "anticipates", "believes",
"estimates", "predicts", "potential", or "continue" and similar
expressions identify forward-looking statements. Actual results,
performance or events may differ materially from those in such
statements due to without limitation, (i) general economic
conditions such as performance of financial markets, credit
defaults , currency exchange rates, interest rates, persistency
levels and frequency / severity of insured loss events, (ii)
mortality and morbidity levels and trends, (iii) changing levels of
competition and general competitive factors, (iv) changes in laws
and regulations and in the policies of central banks and/or
governments, (v) the impact of acquisitions or reorganization,
including related integration issues, and (vi) the susceptibility of our industry
and the markets addressed by our, and our customers’, products and
services to economic downturns as a result of natural disasters,
epidemics, pandemics or other widespread illness, including
coronavirus (or COVID-19), and (vii) other risks and uncertainties
identified in our public filings with the Securities and Exchange
Commission, including those listed under the "Risk Factors" and
"Forward-Looking Statements" sections of our Annual Report on Form
20-F for the year ended March 31, 2019. The company assumes no
obligation to update any information contained herein.”
About FUJIFILM Corporation: FUJIFILM Corporation, Tokyo,
Japan, is one of the major operating companies of FUJIFILM Holdings
Corporation. The company brings cutting-edge solutions to a broad
range of global industries by leveraging its depth of knowledge and
fundamental technologies developed in its relentless pursuit of
innovation. Its proprietary core technologies contribute to various
fields, including healthcare, graphic systems, highly functional
materials, optical devices, digital imaging and document products.
These products and services are based on its extensive portfolio of
chemical, mechanical, optical, electronic and imaging technologies.
For the year ended March 31, 2020, the company had global revenues
of $21 billion, at an exchange rate of 109 yen to the dollar.
Fujifilm is committed to responsible environmental stewardship and
good corporate citizenship. For more information, please visit:
holdings.fujifilm.com.
About Global Response Aid (GRA): Agility (KSE/DFM:
AGLTY), one of the world’s leading logistics companies, and
AiPharma, an innovative pharma research, development and
commercialization company based in Dubai, established Global
Response Aid (GRA) to address the market challenges created by the
COVID-19 pandemic and other threats to public health. GRA delivers
innovative, effective healthcare solutions through a range of
pharmaceutical products and technology platforms. It works closely
with governments, regulatory authorities, hospitals, clinics,
healthcare providers, life sciences companies, NGOs and public
institutions to develop strategies that allow them to tackle public
health challenges. For more information: www.globalresponseaid.com,
www.agility.com.
About AiPharma: AiPharma is an early-stage biotechnology
company with regional offices in Dubai and Tokyo. We take a highly
interdisciplinary approach to science, with our 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. For more
information: 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® (favipiravir) 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.
Appili Forward-Looking Statements
This news release contains “forward-looking statements,” which
reflect the current expectations of the Company’s management for
future growth, results of operations, performance and business
prospects and opportunities, including statements with respect to:
the design, scope and parameters of the proposed Avigan®
(favipiravir) clinical trials and the likelihood that such clinical
trials will be initiated or consummated on the terms and timeline
provided herein or at all; the anticipated timing for the release
of study data; the potential use of Avigan® (favipiravir) for the
treatment of COVID-19 (including as an early treatment of COVID-19
to control disease progression and limit virus spread); and the
development, manufacturing and commercialization plans of the
parties with respect to Avigan® (favipiravir). Wherever possible,
words such as “may,” “would,” “could, “ “should,” “will,”
“anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,”
“potential for” and similar expressions have been used to identify
these forward-looking statements. Forward looking statements
contained in this press release are provided in reliance on certain
assumptions, including with respect to: securing all requisite
required approvals and funding for the applicable clinical trials;
finalizing mutually acceptable clinical trial agreement and related
agreements with the applicable clinical research organizations
relating to the applicable clinical trials; site and patient
enrolment; other expectations and assumptions concerning the
proposed clinical trials (including with respect to timely
completion of such trials and their potential outcomes and
benefits); and the ability of the parties to successfully develop,
manufacture and commercialize favipiravir for the treatment of
COVID-19 following successful completion of the requisite clinical
trials and receipt of all requisite regulatory and other approvals.
Although the Company believes that the expectations reflected in
these forward-looking statements are reasonable, the Company cannot
give assurance that these expectations will prove to have been
correct.
Forward-looking statements involve significant known and unknown
risks, uncertainties and assumptions, including, without
limitation, economic, competitive, political and social
uncertainties; known and unknown risks and liabilities relating to
the ongoing COVID-19 pandemic; risks relating to the inability of
Appili to initiate or complete all requisite clinical trials
(including risks relating to the outcome thereof) and to secure all
required funding and approvals relating thereto; risks relating to
the development, manufacturing and commercialization of Avigan®
(favipiravir) in Canada, the U.S and other jurisdictions;
unforeseen events, developments, or factors causing any of the
aforesaid expectations and assumptions not to be correct; and the
other risk factors listed in the annual information form of the
Company dated June 24, 2020 and the other filings made by the
Company with the Canadian securities’ regulatory authorities (which
may be viewed at www.sedar.com). Should one or more of these risks
or uncertainties materialize or should assumptions underlying the
forward-looking statements prove incorrect, actual results,
performance or achievements may vary materially from those
expressed or implied by the forward-looking statements contained in
this news release. These factors should be considered carefully,
and prospective investors should not place undue reliance on the
forward-looking statements. The Company disclaims any intention or
obligation to revise forward-looking statements whether as a result
of new information, future developments or otherwise, except as
required by law.
The Company is not making any express or implied claims that it
has the ability to eliminate, cure or contain the COVID-19 (or
SARS-2 Coronavirus) at this time.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201221005812/en/
INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com (PH:
+91-40-49002135)
MEDIA RELATIONS APARNA TEKURI aparnatekuri@drreddys.com
(PH: +91-40- 49002446)
Dr Reddys Laboratories (NYSE:RDY)
Historical Stock Chart
From Aug 2024 to Sep 2024
Dr Reddys Laboratories (NYSE:RDY)
Historical Stock Chart
From Sep 2023 to Sep 2024