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Poxel and Sumitomo Dainippon Pharma Announce Initiation of Phase 3 Program for Imeglimin, an Investigational Therapeutic Agent for Type 2 Diabetes, in Japan

by December 27, 2017 General

SA (Euronext – POXEL – FR0012432516, hereinafter called “Poxel”), a
biopharmaceutical company focused on the development of innovative
treatments for metabolic disorders, including type 2 diabetes, and
Sumitomo Dainippon Pharma Co., Ltd (Head Office: Osaka, Japan;
Representative Director, President and CEO: Masayo Tada; Securities
Code: 4506, First Section of TSE, hereinafter called “Sumitomo Dainippon
Pharma”), announced today the initiation of the Phase 3 program for
Imeglimin, an investigational therapeutic agent for type 2 diabetes, in
Japan. Referred to as TIMES (Trials of IMeglimin for Efficacy
and Safety), the Imeglimin Phase 3 program in Japan will
include three pivotal trials to evaluate Imeglimin’s efficacy and safety
in approximately 1,100 patients. In December 2017, the first patient was
included in the TIMES 1 trial, a multicenter, double-blind,
placebo-controlled, randomized, monotherapy study in over 200 Japanese
patients with type 2 diabetes.

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The TIMES program is a joint development effort between Poxel and
Sumitomo Dainippon Pharma. The companies announced on October 30, 2017,
a strategic partnership for the development and commercialization of
Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast
Asian countries.*

“Initiation of the TIMES program is a major milestone for Poxel and for
the development of Imeglimin with our partner Sumitomo Dainippon Pharma.
Based on the success of our Phase 2 program, we have a clear roadmap for
the Phase 3 TIMES program,” said Thomas Kuhn, CEO of Poxel. “Our
near-term focus in Japan is the successful execution of TIMES, and, to
this end, we will work closely with our colleagues at Sumitomo Dainippon
Pharma to support the Japanese New Drug Application submission.”

“Our commitment to diabetes patients is to continue to innovate and
provide the best medicines to help them manage their disease. We are
pleased to be working closely with Poxel and initiating the TIMES
registration studies,” said Nobuyuki Hara, Director, Executive Officer;
Drug Development Division of Sumitomo Dainippon Pharma. “Diabetes is a
significant area for us in Japan and we believe that Imeglimin will be a
very important addition to our existing diabetes franchise.”

Imeglimin is an orally-available drug candidate with a novel mechanism
of action, that has been observed in clinical studies to demonstrate
glucose lowering benefits by simultaneously targeting all three key
organs which play an important role in the treatment of type 2 diabetes:
the liver, muscles and the pancreas. Imeglimin has demonstrated in
preclinical studies the potential to address mitochondrial dysfunction,
which is believed to be at the core of type 2 diabetes pathophysiology.
Imeglimin has completed Phase 1 and Phase 2 development in over 1,200
subjects in the U.S., EU and Japan.

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, will consist of three pivotal
trials involving approximately 1,100 patients. The TIMES program will
include the following three trials that will be performed using the dose
of 1,000 mg twice daily:

TIMES 1: A Phase 3, 24-week, double-blind placebo-controlled,
randomized, monotherapy study to assess the efficacy, safety and
tolerability of Imeglimin in Japanese patients with type 2 diabetes,
using the change in HbA1c as the primary endpoint. Secondary endpoints
of the trial will include other standard glycemic and non-glycemic

TIMES 2: A Phase 3, 52-week, open-label, parallel-group study to assess
the long-term safety and efficacy of Imeglimin in Japanese patients with
type 2 diabetes. In this study, Imeglimin will be administrated orally
as a monotherapy or combination therapy with existing hypoglycemic
agents, including a DPP4 inhibitor, SGLT2 inhibitor, biguanide,
sulphonylurea and GLP1 receptor agonist.

TIMES 3: A Phase 3, 16-week, double-blind, placebo-controlled,
randomized study with a 36-week open-label extension period to evaluate
the efficacy and safety of Imeglimin in combination with insulin in
Japanese patients with type 2 diabetes and inadequate glycemic control
on insulin therapy.

About Imeglimin

Imeglimin is the first clinical candidate in a new chemical class of
oral agents called Glimins by the World Health Organization. Imeglimin
has a unique mechanism of action (“MOA”) that targets mitochondrial
bioenergetics. Imeglimin acts on all three key organs which play an
important role in the treatment of type 2 diabetes: the liver, muscles
and the pancreas, and it has demonstrated glucose lowering benefits by
increasing insulin secretion in response to glucose, improving insulin
sensitivity and suppressing gluconeogenesis. This MOA has the potential
to prevent endothelial and diastolic dysfunction, which can provide
protective effects on micro- and macro-vascular defects induced by
diabetes. It also has the potential for protective effect 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

About Poxel SA

Poxel uses its development expertise in metabolism to advance a pipeline
of drug candidates focused on the treatment of metabolic disorders,
including type 2 diabetes. We have successfully completed our Phase 2
clinical program for our first-in-class lead product, Imeglimin, which
targets mitochondrial dysfunction, in the U.S., EU and Japan, and have
initiated the Phase 3 TIMES program in Japan. Our second program,
PXL770, a direct AMPK activator, is in Phase 1 development. We intend to
generate further growth through strategic partnerships and pipeline
development. (Euronext: POXEL,

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 pouring all our efforts into the
research and development of new drugs, we aim to provide innovative and
effective pharmaceutical solutions to people not only in Japan but also
around the world in order to realize our corporate mission. Sumitomo
Dainippon Pharma aims to create innovative pharmaceutical products in
the Psychiatry & Neurology area and the Oncology area, which have been
designated as the focus therapeutic areas. Sumitomo Dainippon Pharma has
also positioned Psychiatry & Neurology, Diabetes/Cardiovascular and
Speciality areas as our focus marketing areas in Japan. For more detail,
please visit our website. (URL:

*including: Indonesia, Vietnam, Thailand, Malaysia, The Philippines,
Singapore, Republic of the Union of Myanmar, Kingdom of Cambodia, and
Lao People’s Democratic Republic.