- TWYMEEG® is a first-in-class drug with a unique dual
mechanism of action for the treatment of Type 2 Diabetes across the
continuum of the current treatment paradigm, both as a monotherapy
or as an add-on to other glucose lowering therapies
- The approval in Japan triggers a JPY 1.75 billion
(approximately EUR 13.3 million, USD 15.9 million)1 milestone
payment to Poxel from Sumitomo Dainippon Pharma
- TWYMEEG’s target product launch is anticipated in fiscal
year 20212
- The Japanese approval for TWYMEEG is supported by positive
results from the Phase 3 TIMES program in over 1,100 patients in
Japan
POXEL SA (Euronext – POXEL - FR0012432516), a biopharmaceutical
company focused on the development of innovative treatments for
metabolic disorders, including type 2 diabetes and non-alcoholic
steatohepatitis (NASH), and Sumitomo Dainippon Pharma Co., Ltd.
(Head Office: Osaka, Japan; Representative Director, President and
CEO: Hiroshi Nomura; Securities Code: 4506, First Section of TSE),
today announced that a new drug application for TWYMEEG® Tablets
500mg3 (International Nonproprietary Name (INN): Imeglimin
hydrochloride), for the treatment of type 2 diabetes, was approved
in Japan on June 23. Japan is the first country in the world to
approve Imeglimin. The TWYMEEG approval is supported by numerous
preclinical and clinical studies, including the Phase 3 TIMES
(Trials of IMeglimin for Efficacy and
Safety) program managed jointly by Poxel and Sumitomo
Dainippon Pharma, which included three pivotal trials to evaluate
TWYMEEG’s efficacy and safety in over 1,100 patients. In all three
trials, TWYMEEG met its primary endpoints and objectives and was
observed to exhibit a favorable safety and tolerability
profile.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20210622006160/en/
"The TWYMEEG approval in Japan represents a major milestone for
Poxel and the culmination of several years of clinical development
work. This approval is a strong validation of our R&D
capabilities and the international footprint that we have
established. Our vision as a company is focused on developing and
commercializing innovative drugs for metabolic diseases,” said
Thomas Kuhn, CEO of Poxel. “Going forward, we’ll continue to
support Sumitomo Dainippon Pharma in establishing TWYMEEG as a key
treatment for type 2 diabetes in Japan, and in other countries
where Sumitomo Dainippon Pharma has the rights to the product. Our
efforts are also focused on our two first-in-class programs for the
treatment of NASH, PXL770 and PXL065, as well as advancing
earlier-stage opportunities from our adenosine
monophosphate-activated protein kinase (AMPK) activator and
deuterated thiazolidinediones (TZD) platforms in the arena of rare
metabolic disorders.”
The Phase 3 TIMES program was a joint development effort between
Poxel and Sumitomo Dainippon Pharma. The companies entered into a
strategic partnership in October 2017 for the development and
commercialization of TWYMEEG in Japan, China, South Korea, Taiwan
and nine other Southeast Asian countries4.The approval triggers a
JPY1.75 billion (approximately EUR13.3 million, USD15.9 million)5
milestone payment to Poxel. Furthermore, after product launch,
Poxel is entitled to receive escalating double-digit royalties on
net sales and sales-based payments of up to JPY26.5 billion
(approximately EUR200 million, USD230 million)6 in accordance with
sales goals.
“We believe TWYMEEG is an important addition to our existing
diabetes franchise through its differentiated dual mechanism of
action and favorable efficacy and safety profile. Based on the
clinical data obtained in Phase 2 and 3, we believe that it has the
potential for use as a monotherapy, and in combination with other
existing therapies, specifically complementing well our existing
infrastructure in type 2 diabetes. This approval of TWYMEEG allows
us to provide patients with type 2 diabetes the opportunity for
greater flexibility in their treatment regimens,” said Koichi
Kozuki, Executive Officer, Drug Development Division of Sumitomo
Dainippon Pharma. “We are committed to delivering new therapeutic
options to help patients manage their disease.”
About TWYMEEG (INN: Imeglimin hydrochloride)
Imeglimin is the first agent in a new chemical class of
tetrahydrotriazine-containing molecules. It is thought that TWYMEEG
shows a glucose lowering effect by both a pancreatic action that
promotes glucose concentration-dependent insulin secretion and an
extra-pancreatic action that improves glucose metabolism in the
liver and skeletal muscle (suppression of gluconeogenesis and
improvement of glucose uptake) through an action on mitochondria.
This mechanism of action (MOA) has the potential to prevent
endothelial and diastolic dysfunction, which could provide
protective effects on micro- and macrovascular defects induced by
diabetes. It also has the potential for protective effects on
beta-cell survival and function. This unique MOA offers the
potential opportunity for Imeglimin to be a candidate for the
treatment of type 2 diabetes in almost all stages of the current
anti-diabetic treatment paradigm, including monotherapy or as an
add-on to other glucose lowering therapies.
About the TIMES Program
TIMES (Trials of IMeglimin for Efficacy and
Safety), the Phase 3 program for Imeglimin for the treatment
of type 2 diabetes in Japan, consists of three pivotal trials
involving over 1,100 patients, out of which the non-control
individuals were administered the dose of 1,000mg twice daily.
Preliminary results of the three trials were announced in press
releases dated April. 4, 2019 (TIMES1), December 20, 2019 (TIMES2),
and June 25, 2019 (TIMES3). - TIMES1: A Phase 3, 24-week,
double-blind, placebo-controlled, randomized, monotherapy trial
that assessed the efficacy, safety, and tolerability of imeglimin
in Japanese patients with type 2 diabetes. - TIMES2: A Phase 3,
52-week, open-label, parallel-group trial that assessed the
long-term safety and efficacy of imeglimin in Japanese patients
with type 2 diabetes. In this trial, imeglimin was administered
orally as combination therapy with approved hypoglycemic agents,
including a DPP-4 inhibitor, an SGLT2 inhibitor, metformin, a
sulphonylurea, a glinide, an alpha-glucosidase inhibitor, a
thiazolidinedione, and a GLP1 receptor agonist or as monotherapy. -
TIMES3: A Phase 3, 16-week, double-blind, placebo-controlled,
randomized trial with a 36-week open-label extension period that
evaluated the efficacy and safety of imeglimin in combination with
insulin in Japanese patients with type 2 diabetes and Japanese
patients with type 2 diabetes on insulin therapy with inadequate
glycemic control.
About Poxel SA
Poxel is a dynamic biopharmaceutical company that uses its
extensive expertise in developing innovative drugs for metabolic
diseases, with a focus on type 2 diabetes and non-alcoholic
steatohepatitis (NASH), and selected rare inherited disorders
including adrenoleukodystrophy. In its mid-to-late-stage pipeline,
the Company is currently advancing three drug candidates; several
earlier-stage opportunities are also underway. Imeglimin, Poxel’s
first-in-class lead product, targets mitochondrial dysfunction.
Poxel has a strategic partnership with Sumitomo Dainippon Pharma
for TWYMEEG (Imeglimin) in Japan, China, South Korea, Taiwan and
nine other Southeast Asian countries. A new drug application for
TWYMEEG for the treatment of type 2 diabetes was approved in Japan.
After successfully completing a Phase 2a proof-of-concept trial for
the treatment of NASH, which met its primary endpoint and study
objectives, for PXL770, a first-in-class direct adenosine
monophosphate-activated protein kinase (AMPK) activator, Poxel
plans to initiate a Phase 2b program in the second half of 2021.
PXL770 could also have the potential to treat additional metabolic
diseases. PXL065 (deuterium-stabilized R-pioglitazone), is in a
streamlined Phase 2 trial for the treatment of NASH. Poxel also has
additional earlier-stage programs from its AMPK activator and
deuterated thiazolidinediones (TZD) platforms targeting chronic and
rare metabolic diseases. The Company intends to generate further
growth through strategic partnerships and pipeline development.
Listed on Euronext Paris, Poxel is headquartered in Lyon, France,
and has subsidiaries in Boston, MA, and Tokyo, Japan. For more
information, please visit: www.poxelpharma.com
In the context of the COVID-19 outbreak, which was declared a
pandemic by the World Health Organization (WHO) on March 12, 2020,
the Company is regularly reviewing the impact of the outbreak on
its business.
As of the date of this press release, and based on publicly
available information, the Company has not identified the
occurrence of any material negative effect on its business due to
the COVID-19 pandemic that remains unresolved. However, the Company
anticipates that the COVID-19 pandemic could have further material
negative impact on its business operations. The worldwide impact of
COVID-19 may notably affect the Company’s internal organization and
efficiency, particularly in countries where it operates and where
confinement measures are implemented by the authorities. In
addition, COVID-19 may impact market conditions and the Company’s
ability to seek additional funding or enter into partnerships.
Particularly, delays in the supply of drug substance or drug
products, in the initiation or the timing of results of preclinical
and/or clinical trials, as well as delays linked to the
responsiveness of regulatory authorities could occur, which could
potentially have an impact on the Company’s development programs
and partnered programs. The Company will continue to actively
monitor the situation.
About Sumitomo Dainippon Pharma
Sumitomo Dainippon Pharma defines its corporate mission as "to
broadly contribute to society through value creation based on
innovative research and development activities for the betterment
of healthcare and fuller lives of people worldwide". By channeling
our efforts into the research and development of new drugs, we aim
to realize our mission and provide innovative and effective
pharmaceutical solutions not only to people in Japan but also
around the world. Sumitomo Dainippon Pharma's goal is to create
innovative pharmaceutical products in the focus research areas of
psychiatry and neurology, oncology, and regenerative medicine/cell
therapy. For more detail, please visit our website.
(URL:https://www.ds-pharma.com)
All statements other than statements of historical fact included
in this press release about future events are subject to (i) change
without notice and (ii) factors beyond the Company’s control. These
statements may include, without limitation, any statements preceded
by, followed by or including words such as “target,” “believe,”
“expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,”
“project,” “will,” “can have,” “likely,” “should,” “would,” “could”
and other words and terms of similar meaning or the negative
thereof. Forward-looking statements are subject to inherent risks
and uncertainties beyond the Company’s control that could cause the
Company’s actual results or performance to be materially different
from the expected results or performance expressed or implied by
such forward-looking statements.
1 Converted at the exchange rate as of June 21, 2021. 2 Year
noted is Fiscal Year from April to March, which is Sumitomo
Dainippon Pharma’s Fiscal Year. 3 Dosage and administration: In
general, for adults, 1,000 mg of Imeglimin hydrochloride is orally
administered twice daily in the morning and evening. 4 Including
Indonesia, Vietnam, Thailand, Malaysia, The Philippines, Singapore,
Republic of the Union of Myanmar, Kingdom of Cambodia and Lao
People's Democratic Republic. 5 Converted at the exchange rate as
of June 21, 2021. 6 Converted at the exchange rate as of date of
agreement.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210622006160/en/
Poxel SA Catherine David Investor Relations &
Communication Manager catherine.david@poxelpharma.com +33 7 64 57
61 78
Elizabeth Woo Senior Vice President, Investor Relations,
Corporate Communications and Public Relations
Elizabeth.woo@poxelpharma.com
Investor relations / Media - EU/US Trophic Communications
Stephanie May or Valeria Fisher poxel@trophic.eu +49 171 185 56 82
or +49 175 804 1816
Investor relations / Media - France NewCap Emmanuel Huynh
or Arthur Rouillé poxel@newcap.eu +33 1 44 71 94 94
Public relations / Media – Japan/Asia Cosmo PR
poxel@cosmopr.co.jp International Account Manager Tel:
03-5561-2915
Sumitomo Dainippon Pharma Co., Ltd. Corporate
Communications Tel: +81-6-6203-1407 (Osaka); +81-3-5159-3300
(Tokyo)
Poxel (EU:POXEL)
Historical Stock Chart
From Feb 2024 to Mar 2024
Poxel (EU:POXEL)
Historical Stock Chart
From Mar 2023 to Mar 2024