MC2 Biotek "Introducting PADciclo" presented at OIS@AAO 2014

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Introducing PADciclo™
- because tolerability matters
Ophthalmology Innovation Summit, October 16th 2014
PAD™
Technology
-­‐
releasing
the
full
poten1al
of
API’s
2014

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MC2 Biotek Group at a glance
§ Privately
held
Danish
company
§ Major
investor
is
family
behind
Danfoss
Group
(USD
6
bn)
§ Long
term
commitment
–
flexible
collabora1on
models
§ PAD™ Technology
–
releasing
full
poten;al
of
API’s
§ Key
to
a
successful
drug
is
a
label
recognized
by
payers
and
clinicians
as
clinically
superior
§ Focus:
Clinically
superior
PAD™
versions
of
high-­‐value
marketed
topical
drugs
§ PADciclo™
Dry
eye
(phase
II
star1ng
up)
§ PADcombo™
Psoriasis
(phase
II
ongoing)
§ Atopic
derma11s
(phase
I,
Q1
2015)
§ Other
PAD™
topical
projects
in
pre-­‐clinical
development
§ Operates
through
a
network
based
business
model
§ Company
loca1ons
in
Copenhagen
and
London
§ Project
teams
of
highly
reputed
experts
in
the
US
and
EU
§ Strategic
collabora1ons
with
academia
and
hospitals

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PADciclo™- need for 2nd generation CsA eye drop
Ra;onale
Challenge
Solu;on
by
PADciclo™
Restasis®
is
twice
daily,
it
s1ngs
and
has
sub-­‐op1mal
label
–
yet
a
blockbuster
Need
for
improved
CsA
product
in
the
US
Need
for
approved
CsA
products
in
EU
Reduce
s1nging
(CsA
will
always
s1ng
in
some
pa1ents)
§ Reduce
surfactant
level
~30
fold
§ Reduce
concentra1on
of
CsA
Once
daily
dosing
§ CsA
penetra1on
~4
fold
be]er
than
Restasis®
Get
best
in
class
claim
for
“treatment”
§ Novel
clinical
strategy

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PAD™ droplets are robust with low level of surfactants

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>1,000 patients treated with PADciclo™ 0.06% in the UK
Collabora;on
with
Moorfields
Pharmaceu;cals
(Moorfields
Eye
Hospital)
§ Available
in
the
UK
since
April
2012
as
a
0.06%
preserva1ve
free
unlicensed
Special
§ Repeated
sales
to
>300
hospitals,
clinics,
wholesalers
and
pharmacies
§ More
than
1,000
pa1ents
have
been
treated

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MEH analysis of 129 patient files is very encouraging
Safety:
§ PADciclo™
0.06%
is
safe
§ No
decrease
in
visual
acuity,
no
effect
on
intraocular
pressure
and
no
vital
signs
Efficacy:
§ Qualita1ve
data
reported
by
pa1ents
and
ophthalmologists
show
improvement
of
clinical
status
of
dry
eye
pa1ents
(Be]er,
Stable,
Worse)
Ophthalmologists
Pa;ents
BePer
66%
69%
Stable
34%
27%
Worse
0%
4%
Data
from
dry
eye
pa1ent
files
with
sufficient
data

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PADciclo™ is preferred by patients at MEH
PADciclo
0.6%
CsA
survey
(n=23)
conducted
by
Moorfields
Eye
Hospital
(Feb-­‐April
2013)
Author:
Kris1n
Chapman
(Formulary
&
An1bio1c
Pharmacist)

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PADciclo™ is well tolerated and increases ocular delivery
Ocular
PK
data
support
once
daily
ins;lla;on
at
strengths
of
0.03%
and
0.06%
w/w
CsA
§ PK
studies
in
rabbits
show
superior
ocular
exposure
of
PADciclo™
compared
to
Restasis®
§ PADciclo™
once
daily
is
sufficient
for
saturated
delivery
to
cornea
and
conjunc1va
0
1
2
3
4
5
6
PADciclo
0.06%,
1x
PADciclo
0.06%,
2x
PADciclo
0.1%,
1x
PADciclo
0.1%,
2x
0.05%
Restasis
Fold
Exposure
over
Restasis
(AUC0-­‐24h)
Cornea
Conjunc1va
Ocular
Exposure
rela;ve
to
Restasis®
PADciclo
is
safe
and
very
well
tolerated
up
to
6
months
§ Rabbit
safety
and
tolerability
studies
conducted
at
0.1%
strength
with
2-­‐4
1mes
daily
dosing
§ No
treatment
or
administra1on-­‐related
effects
§ Systemic
exposure
of
ciclosporin
is
very
low

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Large PADciclo™ phase II trial is starting up
PADciclo™
has
the
required
poten;al
§ Excellent
pre-­‐clinical
data
§ Large
scale
manufacture
in
unit
dose
secured
§ Once
daily
dosing
and
high
tolerability
are
key
for
pa1ent
compliance
§ Experience
from
>1,000
pa1ents
in
the
UK
and
129
pa1ent
files
§ Outcome
of
Scien1fic
Advice
mee1ngs
support
our
clinical
strategy
Fast
to
market
and
best
in
class

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Opportuni;es
using
PAD™
vehicle:
§ Reformulate
high
value
marketed
drugs
+
LCM
§ Release
the
full
poten1al
of
API’s
from
first
formula1on
PAD™ Technology - release the full potential of API’s
§ The
right
vehicle
can
provide
the
twist
that
makes
a
superior
product
§ PAD™
Technology
does
not
impose
addi1onal
risk
-­‐
only
pharmacopeial
excipients
§ Key
differen1a1ng
features
of
the
PAD™
Technology:
Penetra1on
Solubility
Stability
Compliance
Tolerability
Patented

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Click to edit Master title styleWe welcome collaboration
Thank you for your attention