DC Bead M1 Training Presentation June 2012EC12-074rev1

Biocompatibles UK Ltd is a
BTG International group company

Disclaimer
• DC BeadM1 is CE marked and is indicated for the treatment of malignant

hypervascular tumours and loading with doxorubicin drug. DC Bead® is also
indicated for loading with irinotecan for the treatment of metastatic colorectal cancer
(mCRC). DC Bead® is not available for sale, distribution, or promotion in the United
States
• Copies of this presentation, and any supporting material are confidential and are for
internal, educational purposes only, and must not be used or distributed in the field
• Although the information in this presentation has been produced and processed
from sources believed to be reliable, no warranty express or implied is made or
assumed regarding accuracy, adequacy, completeness, legality, or reliability of any
such information, and any and all such warranties are expressly disclaimed.
• DC Bead® is a registered trademark of Biocompatibles UK Ltd. and DC BeadM1 is a
trademark of Biocompatibles UK Ltd. Biocompatibles UK Ltd is a BTG International
group company. BTG and the BTG roundel logo are registered trademarks of BTG
International Ltd. Copyright © 2012, Biocompatibles UK Ltd. EC12-074 Rev 1.
2
DC BeadM1 is manufactured by Biocompatibles UK Ltd, Chapman House, Farnham Business Park, Weydon Lane, Farnham, Surrey, GU9 8QL, UK. Biocompatibles UK Ltd is a BTG International group company.
DC BeadM1 is a registered trademark of Biocompatibles UK Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. © Copyright 2012 Biocompatibles UK Ltd. ECXX-XXX Rev 1.
DC BeadM1 – Indication1
DC
DC Bead M1 is primarily intended as an embolic agent for the
BeadM1 is primarily intended as an embolic agent for the
treatment
treatment of
of malignant
malignant hypervascularised
hypervascularised tumour(s).
tumour(s).
DC
DC Bead
BeadM1 M1 is compatible with doxorubicin, which can be
is compatible with doxorubicin, which can be
loaded
loaded prior
prior toto embolisation
embolisation and
and then,
then, as
as aa secondary
secondary action,
action,
elute
elute aa local,
local, controlled
controlled and
and sustained
sustained dose
dose toto the
the tumour
tumour
after
after embolisation.
embolisation.
DC
DC Bead
BeadM1 M1 is primarily intended as an embolic agent to treat
is primarily intended as an embolic agent to treat
vessels
vessels supplying
supplying malignant
malignant colorectal
colorectal cancer
cancer metastasised
metastasised to
to
the
the liver
liver (mCRC).
(mCRC).
DC
DC Bead
BeadM1 M1 is compatible with irinotecan, which can be loaded
is compatible with irinotecan, which can be loaded
prior
prior to
to embolisation
embolisation andand then,
then, as
as aa secondary
secondary action,
action, elute
elute aa
local,
local, controlled
controlled andand sustained
sustained dose
dose toto the
the mCRC
mCRC after
after
embolisation.
embolisation.
3
DC Bead® v DC BeadM1 size distribution²
70
DC Bead
60 DC BeadM1
DC BeadM1 with dox
50
DC BeadM1 with iri

40
Frequency
30
20
10
0
50-60 70-80 90-100 110-120 130-140 150-160 170-180 190-200 210-220 230-240 250-260 270-280 290-300 310-320
Range (µm)
• DC BeadM1 has a narrower distribution that DC Bead²
• DC BeadM1 reduces in size by 20-30% when loaded with irinotecan and
doxorubicin¹
4
DC Bead® v DC BeadM1 size distribution
Unloaded irinotecan doxorubicin
DC Bead®
100-300µm
DC BeadM1
5
In vitro vessel embolisation model –
DC Bead® comparison³,
6
In vitro vessel embolisation model³
In vitro - Relative penetration (µm)

DC Bead
100-300µm
~200,000 beads*
DC BeadM1
~ 1,300,000 beads*
DC BeadM1 DC Bead
• DC BeadM1 has a narrower distribution that DC Bead®

– May allow more beads go more distal
– May allow doctor to be deliver a more selective embolisation
– Effective at penetrating metastatic tumours and avoiding premature proximal occlusion
of tumour-feeding vessels.
*Theoretical calculation based on the average diameters of a normal distribution of beads in a vial. Biocompatibles data on file
7
DC BeadM1 – Loading4
D o x o ru b ic in L o a d in g (% )
Loading times for up to 75 mg

doxorubicin per vial*
Doxorubicin loading Doxorubicin
100 60 uptake
90
80 mins
70 90% 30 mins
60
50
40 98% 60 mins
30
20
10 *tolerence +/- 3%
0
0 20 40 60 80 100 120 140
Time (minutes)
• DC BeadM1 loads at the same rate as DC Bead® 100-300µm

• As with the irinotecan gentle agitation when loading DC BeadM1 with doxorubicin is
required more frequently than with DC Bead®
8
DC BeadM1 – In vitro elution5
Elution profile
% of dose eluted
100
80
60
40
20
0
0 20 40 60 80 100 120 140 160 180 200
Time /mins
DC BeadM1
• DC BeadM1 completely elutes under in vitro conditions
9
Animal Model - Kidney Model6
• 70-150µm beads
penetrated more
distally in the
vasculature
– May allow the doctor
to deliver greater
volume of beads
and drug
intratumourally and
lead to greater
intratumoural
devascularisation
10
In vivo doxorubicin concentration
DC BeadM1 vs. DC Bead® (100-300μm) 7
p=0.1
p=0.05
DC BeadM1
DC Bead
Tumour Core Tumour Periphery
p=0.05
• More drug delivered to the tumour core and around the tumour periphery
with DC BeadM1
– May lead to increased efficacy
11
DC BeadM1 Summary
• DC BeadM1 has similar loading and elution characteristics to

DC Bead®
• Penetration model showed DC BeadM1 to deliver beads more
distally
• Animal models confirmed DC BeadM1 ability to deliver beads more
distally (Kidney model) with more drug delivered to the core and
periphery of the tumour (VX2) these results may allow the following:
– More concentrated drug delivery with in the turmour and greater
tumoural devascularistaion
– May allow the doctor to be more selective and target only the vessels
feeding the tumour and so protect the healthy liver and reduce stress
to cirrhotic liver
– Effective at penetrating metastatic tumours and avoiding premature
proximal occlusion of tumour-feeding vessels.
12
Key Messages
• More concentrated drug delivery with in the turmour and

greater tumoural devascularistaion
• May allow the doctor to be more selective and target only the
vessels feeding the tumour and so protect the healthy liver
and reduce stress to cirrhotic liver
• Effective at penetrating metastatic tumours and avoiding
premature proximal occlusion of tumour-feeding vessels.
13
Marketing Materials
14
Marketing Materials
15
References
1. DC BeadM1 Instructions for use CN00495.1 and CN00496.1

2. Data on file – report VPP035
3. Data on file – report SP2179
4. DC BeadM1 loading instructions EC 12-076 Rev 1
5. Data on file – SP2123
6. Dreher MR et al. Radiopaque drug-eluting beads for transcatheter
embolotherapy: experimental study of drug penetration and coverage in
swine. J Vasc Interv Radiol. 2012 Feb; 23(2): 257-64
7. Geschwind J et al. Doxorubicin Eluting Bead Sizes 100-300μm and 70-
150μm in the VX2 Model. Presented at ECIO 2012 (Terumo Symposium).
16

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Biocompatibles UK Ltd is a

BTG International group company

• DC BeadM1 is CE marked and is indicated for the treatment of malignant

DC BeadM1 with iri

Unloaded irinotecan doxorubicin

In vitro - Relative penetration (µm)

• DC BeadM1 has a narrower distribution that DC Bead®

Loading times for up to 75 mg

• DC BeadM1 loads at the same rate as DC Bead® 100-300µm

• DC BeadM1 completely elutes under in vitro conditions

Tumour Core Tumour Periphery

• DC BeadM1 has similar loading and elution characteristics to

• More concentrated drug delivery with in the turmour and

1. DC BeadM1 Instructions for use CN00495.1 and CN00496.1

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