Diapositive 1

1
JMV 1843 a Ghrelin Receptor Agonist Candidate
for Clinical Development

• JMV 1843 pharmacological profile
• Binding affinity to GHS-R1a IC50 40 nM
• Binding affinity to h-Pituitary Glands IC50
  23 nM
• Binding affinity to h-Hypothalamus IC50 15 nM
• Activation of GHS-R1a in vitro (calcium release)
  ED50 0.8 nM
• GH secretagogue effect by i.v., s.c. injection in
  rats
• GH secretagogue effect by s.c. and oral route at
  1 mg/kg in dogs
• Requirements for the performance of a first trial
  in humans
• Preparation of amount of substance necessary for
  the preclinical studies at a GMP (Good
  Manufacturing Procedure) quality
• Acute toxicity studies in males and females of 2
  animal species
• No toxic dose of JMV 1843 by i.v. route 30 mg/kg
• Toxicity after repeated administration (2 to 4
  weeks) in 2 animal species
• Maximum tolerated dose of JMV 1843 3 mg/kg/day
  by i.v. route
• Safety pharmacology tests including central
  nervous system, cardio-vascular system,
  gastro-intestinal and metabolic assays
• Evaluation of mutagenic potential
• Preparation of a pharmaceutical formulation
  suitable for i.v. and oral administration in
  humans
• Clinical trial authorization after approval by an
  Ethic Committee

2
Phase 1 Clinical Study of JMV 1843 Administered
by Oral Route (Healthy Males)
OBJECTIVES To demonstrate the effect of JMV
1843 on GH secretion To investigate the effect
on ACTH Cortisol Ghrelin Prolactin Insulin
and Glucose To delineate the pharmacokinetic
profile of JMV 1843 To assess safety/tolerability
METHODS 36 healthy, male subjects were
included in this study A dose escalation study
investigating 5 different doses (0.005 0.05
0.125 0.25 and 0.5 mg/kg) of JMV 1843 as a
single oral administration of an aqueous solution
in comparison to a placebo
3
Phase 1 clinical study of JMV 1843 administered
by oral route

• JMV 1843 was well tolerated and no adverse events
  were reported
• Maximal GH release was achieved following 0.5
  mg/kg orally
• Maximal GH release is achieved when plasma levels
  of JMV 1843
• are between 5 6 ng/ml
• Stimulation of GH appears to be selective as no
  other hormones measured were affected by
  administration of JMV 1843 (No effects on ACTH
  cortisol ghrelin prolactin insulin and
  glucose)
• Next development phase is Phase 2 clinical study
  in cachectic cancer patients who can benefit from
  the anabolic effect of GH stimulated by JMV 1843

4
Edinburgh, UK, 21 May 2007 Ardana today
announces that the US Food and Drug
Administration (FDA) has granted Orphan Drug
status for ARD-07 (JMV1843), its oral Growth
Hormone Secretagogue (GHS), which Ardana is
developing as a diagnostic for growth hormone
deficiency in adults. The diagnostic clinical
development and toxicology programmes are ongoing
and, subject to clinical outcome, the Company
anticipates filing for registration at the end of
the year with a possible launch in 2008. Ardana
believes that GHS oral formulation will give
clinicians a simpler and more effective test for
growth hormone deficiency. Dr. Maureen Lindsay,
Ardanas CEO, said We are delighted and very
encouraged that the FDA have granted Orphan Drug
status for GHS. We believe that GHS could play a
very important role in providing clinicians with
a convenient, reliable and effective diagnostic
test for growth hormone deficiency. In addition
to its possible use as a diagnostic, Ardana
intends to undertake clinical trials to support
registration of GHS in a number of adult
therapeutic indications.
5
ARDANA COMMENCES PHASE III REGISTRATION TRIAL FOR
ITS ORAL GROWTH HORMONE SECRETAGOGUE
DIAGNOSTIC Edinburgh, UK 8 August 2007
Ardana plc (LSEARA) today announces the
commencement in the USA of a planned pivotal
registration study of its oral growth hormone
secretagogue (GHS) ARD-07 (JMV1843) which is in
development for the diagnosis of growth hormone
deficiency in adults. Results from the study
are expected in the second half of 2007 and the
Company anticipates filing for registration at
the end of the year with a possible launch in
2008. This phase III study is a multi-centre,
randomized, cross-over study investigating the
safety and effectiveness of oral GHS as a Growth
Hormone (GH) stimulation test. The study will be
conducted under an Investigational New Drug (IND)
application accepted by the U.S. Food Drug
Administration (FDA) in 10 centres in the USA
with 80 subjects. Half of the subjects will be
patients with proven GH deficiency and the other
half will be matched controls (healthy subjects).
As previously announced, the FDA granted Orphan
Drug status for GHS in May 2007. Dr Maureen
Lindsay, Ardanas CEO said This trial is an
important step forward in the development of GHS,
which we believe could play a pivotal role in the
diagnosis of growth hormone deficiency by
providing clinicians with a convenient, reliable
and effective diagnostic test.