2013-03-07 10:05:08 -

Poxel S.A. /
First Patient In for Poxel's Imeglimin Phase IIb Monotherapy Trial to Treat Type 
2 Diabetes 
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Lyon,  France, March  7, 2013, - Poxel  SA, today  announced the initiation of a
phase  IIb clinical trial of Imeglimin, a novel compound in development for Type
2 diabetes.  The first patient was included in the trial which will span USA and
Europe. The trial will assess the dose-response of Imeglimin at four dose levels
compared  to placebo  in Type  2 diabetes patients  after 24 weeks of treatment,
using the change in glycosylated hemoglobin (HbA1c) as the primary endpoint.

Over    350 patients are expected to be  tested in the multi-center, double-blind,
placebo-controlled,  randomized study with five  parallel groups, four Imeglimin
groups  and  one  placebo  group.  Secondary  endpoints of the trial include the
optimal dose and activity of Imeglimin compared to placebo on other glycemic and
non-glycemic  parameters.  Furthermore,  this  phase  IIb  trial will assess the
tolerability and safety of Imeglimin compared to placebo.

Thomas  Kuhn,  CEO  of  Poxel  noted:  "This  is  a very important milestone for
Imeglimin  and Poxel;  we have  already proved  Imeglimin as an excellent add-on
therapy  to  the  standard  treatments  for  Type  2 diabetes.  With  this trial
including over 350 patients, it is our intention to confirm Imeglimin's efficacy
in monotherapy, and complete our data package for partnering discussions."

The  main patient inclusion criteria for the trial are: either men or women aged
between  18 and  75 years  of  age  with  Type  2 diabetes,  who  at the time of
screening  are either  not on  anti-diabetic agents  or treated  with oral anti-
diabetic monotherapy, including metformin, sulfonylurea, dipeptidyl peptidase 4
(DPP-  4) inhibitors, glinide or acarbose. Some  patients presenting with a mild
to moderate renal impairment will also be recruited in the trial.

Imeglimin  represents a new  treatment option for  Type 2 diabetic patients, for
whom  a significant unmet need remains. To date more than 400 subjects have been
treated  in clinical trial settings, which  proved Imeglimin effective, safe and
well tolerated.

About Imeglimin

Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the
Glimins.  Imeglimin has a mitochondrian-based mechanism of action, targeting the
respiratory  chain. Through this new mechanism,  Imeglimin acts on the three key
defects  of  Type  2 diabetes,  inhibiting  hepatic  gluconeogenesis, increasing
muscle  glucose uptake and  restoring normal insulin  secretion. Imeglimin phase
IIa  monotherapy results were  published in Diabetes,  Obesity and Metabolism in
April 2012. In November 2012, Poxel reported phase II results of Imeglimin as an
add-on   therapy   to  sitagliptin  in  patients  inadequately  controlled  with
sitagliptin  monotherapy. The  study achieved  its primary  endpoint of reducing
HbA1c  from  baseline  to  week  12 vs.  placebo plus sitagliptin. Specifically,
Imeglimin led to a significant reduction in HbA1c compared to placebo (p<0.001).
Imeglimin  also met the secondary end-  point of reducing fasting plasma glucose
(FPG)  from baseline  to week  12 vs. placebo  (p<0.006). In October 2011, Poxel
reported  phase  II  results  of  Imeglimin  as  add-on  therapy to metformin in
patients inadequately controlled with metformin monotherapy. This study achieved
its   primary  end-point  of  superiority  in  HbA1c  reduction  versus  placebo
(p<0.001).  This trial  was published  online ahead  of print  in Diabetes Care.
Thanks  to its  mode of  action and  its great  safety and tolerability profile,
Imeglimin  appears as  an excellent  partner to  complement current  major anti-
diabetic treatments.

About Type 2 Diabetes

Type  2 diabetes  is  the  most  common  type  of diabetes. It usually occurs in
adults,  but  is  increasingly  seen  in  children  and  adolescents. In Type 2
diabetes, the body is able to produce insulin but it is either not sufficient or
the  body is not responding to its effects,  leading to a build-up of glucose in
the  blood. Type 2 diabetes is  a major cause of  both cardiovascular and kidney
diseases.

The number of people with Type 2 diabetes is rising rapidly worldwide. This rise
is   associated   with  economic  development,  ageing  populations,  increasing
urbanization,  dietary changes, reduced  physical activity and  changes in other
lifestyle patterns.

The International Diabetes Federation estimates that in 2011, 366 million people
around the world have diabetes. This total is expected to rise to 552 million in
2030. Each  year a further 7 million people develop diabetes. The current market
is  dominated by few product classes and significant unmet needs remain for both
physicians and patients.

The  worldwide  pharmaceutical  market  for  Type  2 diabetes,  60% of  which is
represented  by  oral  anti-diabetics,  is  expected  to  nearly double from $26
billion in 2011 to $48.8 billion in 2021.

About Poxel SA

Poxel,  founded in  2009, is a  biopharmaceutical company  developing innovative
first-in-class  drugs,  with  a  primary  focus  on Type 2 diabetes. The company
develops   drug   candidates   to   clinical   proof-of-concept  before  seeking
pharmaceutical  industry  partners.  Poxel  was  spun  out from Merck Serono. It
operates  independently  as  a  lean  organization  with  strong  in-house  drug
development expertise.

Poxel's  product  pipeline  consists  of  several first-in-class Type 2 diabetes
products,  including Imeglimin in phase  II development. Recently, Imeglimin has
also  shown  significant  clinical  benefits  in  Type 2 diabetes, when added to
sitagliptin.  The Phase II  study achieved the  primary and secondary endpoints.
Previously,  Imeglimin has  shown incremental  efficacy as  an add-on therapy to
metformin,  in  patients  inadequately  controlled  by monotherapy. In addition,
Poxel  develops direct AMPK activator compounds with one being close to entering
phase I clinical trials for the treatment of Type 2 diabetes.

For more information, please visit www.poxel.com.

 Media Contacts

 Poxel SA                                    MC Services AG

 Mrs. Pascale Malgouyres                     Mr. Raimund Gabriel

 Business Development and Marketing Director Managing Partner

 Phone: +33 437 372 012                      Phone: +49 89 2102 280

 Email: pascale.malgouyres@poxelpharma.com   Email:         raimund.gabriel@mc-
                                             services.eu




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