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A lHHealthcare
lth C
Conference
f
San Francisco • January 14, 2010
®
Injectable prandial insulin - 505(b)(2) PDUFA ’10
BIOD-Adjustable Basal
Diabetes
Injectable adjustable basal insulin - 505(b)(2)
BIOD-Smart Basal
All p
product candidates invented in-house on VIAdel™ p
proprietary
p y technology
gy
4,000
3,500
3,000
2 00
2,500
$ MM
Rapid Acting
2,000
Regular Insulin
1 500
1,500
1,000
Proprietary Rapid Insulins
500 3 X Price of RHI
-
2004 2005 2006 2007 E 2008 F
3,500
3,000
2,500 Novolog
2,000 Humalog
Apidra
1,500
1,000
500
‐
2007 2008 2009
120
Blood Gluc
100
ma Insulin
U/ml)
80
-140
(µU
cose (mg/dl)
Plasm
60
-80
40
20
0
Analog
insulin's
insulin s have
modified the
primary
structure
using
i geneticti
engineering
Removal of zinc
via EDTA de-
stabilizes the
h
hexamer off
insulin
Citric
Cit i acid
id
masks surface
charges and
destabilizes the
Hexamer of
Insulin
Modifications
Promotes monomerization of insulin
Neutralized surface charges enhance absorption into bloodstream
Prevents insulin from re-aggregating under the skin
RAPID Absorption
© Biodel Inc. 2010
28th Annual Healthcare Conference www.biodel.com
San Francisco • January 14, 2010 11
Intellectual Property – US and Europe
■ The United States Patent and ■ On October 10th 2008 the European
Trademark Office issued U.S. Patent Office notified Biodel of
Patent No. 7,279,457 to Biodel® intent to issue patent
■ The patent will expire January 2026 ■ The patent will expire March 2025
100
90
80
70
max
% Insulin Cm
60
50
40
30
20
10
0
0 10 20 30 40 50 60 70 80 90 100 110 120
Time (min)
12 12 IU Humulin®
min.
12 IU Humalog®
Baseline corr. GIR mg/kg/m
10
12 IU VIAject®
8
0
0 1 2 3 4 5 6 7 8
180
170 Humulin® R
160
od Glucose ((mg/dl)
150
140
130 Humalog
H l ®
120
VIAject®
110
Bloo
100
90
Meal
80
70
60
0 60 120 180 240 300 360 420
VIAject®
DMA (mm
0.05
AD
0.00
-0.05
■ 6 month duration
Non-inferiority HbA1c
Hypoglycemia
Weight
Safety
Type 1
■ + Reduction in Severe Hypoglycemia
■ + Less Weight Gain
■ - Pain on Injection believe due to larger volume of clinical 25IU formulation
■ since replaced by more tolerable 100IU pH7 formulation
■ = HbA1c control achieved non inferiority after exclusion of anomalous data from India
Type 2
■ + Reduction in non-Severe Hypoglycemia
■ + Less Weight Gain
■ - Pain on Injection
j believe due to larger
g volume of clinical 25IU formulation
■ since been replaced by 100IU pH7 formulation
■ = HbA1c control achieved non inferiority
■ NDA includes:
10 mL vial
3 mL pen cartridge
Re-usable pen referenced in NDA
PROBLEM:
• Variability across dose levels
y
Consistent 24 hour
C i 2 h
duration is difficult to
achieve across patients • Variability across patients
SOLUTION: • 3 formulations would be marketed
3f l ti ld b k t d
A basal insulin with (short, medium and long)
adjustable duration would • Formulations could be mixed for further
allow physicians to
allow physicians to customization
personalize the insulin to • Physician relies on CGM or MBG diary to
determine adjustment required
a patient’s specific needs
30
uction in durattion
25
20
Percent redu
1
15
10
0
6 1
Excipient units
OPPORTUNITY:
■ Pump therapy coupled with CGM holds great promise
■ Can eventually be developed into a fully functional artificial
pancreas (JDRF, J&J).
■ Adding the “glucagon brake” to match the “insulin accelerator.”
Intractable Insulin
Intractable Insulin Orphan indications
Orphan indications ‐ pursue for
pursue for Diseases such as noninsulinoma
such as noninsulinoma
Mediated humanitarian reasons and to support pancreatogenous hypoglycemia
Hypoglycemia critical KOL endocrinologists syndrome and insulinoma currently
have no effective treatment
80
gon %
Remaining Glucag
60
BIOD-G-008
40
Control-Lilly
R
20
0
0 1 2 4 7 10 15
Time
9 30 09
9/30/09
Thank you
P
Presentations
t ti available
il bl at:
t www.biodel.com
bi d l
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