EX-99.1 2 dex991.htm PRESENTATION MATERIALS FOR THE INVESTOR PRESENTATION BY SCOLR PHARMA, INC. Presentation materials for the investor presentation by SCOLR Pharma, Inc.
SCOLR Pharma, Inc.
Amex:  DDD
Self Correcting Oral Linear Release -
Enabling Technologies for Oral Medications
SCOLR Pharma
TM
TM
CDT®
is a registered trademark of SCOLR Pharma, Inc.
SCOLR & CDT logo and design are trademarks of SCOLR Pharma, Inc.
Exhibit 99.1


SCOLR Pharma, Inc.
Amex:  DDD
Forward-Looking Statements
This
presentation
contains
forward-looking
statements
within
the
meaning
of
the
Private
Securities
Litigation
Reform
Act
of
1995
that
involve
significant
risks
and
uncertainties.
These
statements
represent
management’s
present
expectations
of
future
events
and
are
subject
to
a
number
of
important
factors
that
could
cause
actual
results
to
differ
materially
from
those
described
in
the
forward-looking
statements
including:
The timing of product introductions
Product development & clinical timelines
Availability of Additional Financing
Regulatory approvals and government regulation
Modifications to business strategy
Please
refer
to
the
risk
factors
and
other
cautionary
language
included
in
our
reports
and
other
filings
with
the
Securities
and
Exchange
Commission
and
available
on
our
website.
We
assume
no
obligation
to
update
these
forward-looking
statements.


SCOLR Pharma, Inc.
Amex:  DDD
The SCOLR Opportunity
SCOLR
Pharma™
is
a
specialty pharmaceutical/oral
drug delivery company
Develops, licenses and
commercializes novel products
based on its innovative CDT
platform
Newly patented and broadly
applicable, CDT provides
technological and cost savings
benefits for Pharmaceutical,
OTC and Health Supplement
products
$78 billion global drug delivery
market is expected to double in
five years
Licensing revenues generated
from health supplements
Pharma and OTC formulations
with significant market potential
TM


SCOLR Pharma, Inc.
Amex:  DDD
SCOLR Pharma Overview
Shares
Outstanding: 34.9m
Fully Diluted: 40.3m
Approx. Float: 30.6m
Market Cap. (Jan. 23, ’06)
Approx. $252 million
Cash (Sept. 30, 2005)
$16.2 million   
Experienced Management Team
Development relationship with
Temple University’s Industrial
School of Pharmacy
Board Members with extensive
Regulatory/Pharma/Financial
Expertise
TM


SCOLR Pharma, Inc.
Amex:  DDD
Drug Delivery
Routes*
Oral = 46%
Inhalation
Injectable
Transdermal
Others
What Is Drug Delivery ?
*Datamonitor 2003
Definition:
Technology
utilized
to
improve
the
safety
and
efficacy
of
a
drug
and/or
to
prolong
its
commercial
viability
as
it
goes
off-patent.
U.S. ’05 = $32 billion
Est.
U.S. ’08 = $46.8 billion


SCOLR Pharma, Inc.
Amex:  DDD
Competitive Landscape
*Includes
75
key
drug
delivery
companies
as
identified
through
HA
analysis;
“Other”
refers
to
oral
site-directed,
taste-masking,
buccal
and
peptide
technologies
Sources:
Drug
Delivery
Companies
Report
Summer
2003;
Dorlands
2003,
Frost
and
Sullivan
2001,
Drug
Delivery
Technology
Vol.
3
Num.
3
May
2003.
52
36
62
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
Controlled/
Sustained
Release
Solubility
Enhancing
Other
Drug Delivery Technology
50
Multiple
Drugs in
Single Dose
23
Fast
Dissolve


SCOLR Pharma, Inc.
Amex:  DDD
Investment Highlights
Revenue
Potential
Licensing
Ready
Formulations
Risk Mitigation Factors
Value Driving Opportunities
Historically Rich Market Valuations


SCOLR Pharma, Inc.
Amex:  DDD
Revenue (Current and Potential)
Licensing revenues generated by health supplements 
Note: Alliance with Perrigo
in Oct. 2005
OTC –
1
st
two formulations in Clinical Evaluation
12
hour
Ibuprofen
($8
billion
global
OTC
analgesic
market)
–Potential
to become
the
first
U.S.
Extended
Release
Ibuprofen.
Licensed
CDT
applications
for
ibuprofen
products
to
Wyeth
Consumer
Health
(Dec. 2005).
12
hour
Pseudoephedrine
($1
billion
market)
Expect
to
File
ANDA
in 2006.
OTC
Other
OTC
Targets
In
Development
Prescription
Drugs
Initial
Targets
Identified
IR Raloxifene, ER Ondansetron (Combined $2.4 billion existing market)
IR
Raloxifene
-
Pilot
study
completed,
results
positive
24
hour
Ondansetron
Pilot
study
dosing
complete,
Data
analysis
Q1, 2006.
Investment Highlights


SCOLR Pharma, Inc.
Amex:  DDD
Risk Mitigation Factors
CDT technology platform based on a portfolio of recently issued and pending
patents applicable to a large number of compounds with significant global
sales
Proven technology
Clinical Testing
24-hour CDT-Niacin
12-hour CDT-Ibuprofen
12-hour CDT-Pseudoephedrine
IR CDT-Raloxifene
ER CDT-Ondansetron
Six
animal
studies
for
“Proof
of
Process”
for
Amino
Acid
Technology
Successful Commercialization
Six Health Supplements currently on market at major retailers
Over
100
million
tablets
shipped
to
date
(Wal-
Mart,
Rite
Aid,
Trader
Joe’s, GNC)
Investment Highlights


SCOLR Pharma, Inc.
Amex:  DDD
Value Driving Opportunities
Program Initiation and Development with funding raised from
$15.0 million equity financing in February 2005
Initiation and completion of each step towards product
commercialization
Agreements with licensing and/or marketing partners
Expansion of Intellectual Property
Five new patent applications in ’04
Fourth U.S. Patent Issued and Several full-Patent
Applications Submitted in ’05
Several new patent applications planned for ‘06
Investment Highlights


SCOLR Pharma, Inc.
Amex:  DDD
Investment Highlights
Historically Rich Market Valuations for Successful
Companies
An analysis of selected companies operating in the
same space have considerably higher valuations
Andrx
(Nasdaq: ADRX): 
$1.28 billion
Biovail (NYSE: BVF)         
$4.00 billion
Depomed
(Nasdaq: DEPO)
$274.5 million
Flamel
(Nasdaq: FLML):   
$529.5 million
Impax
(Nasdaq: IPXLE):     
$605.3 million
Pozen
(Nasdaq: POZN):
$451.3 million
Skyepharma
(Nasdaq: SKYE) 
$507.3 million
Approx. Valuations as of Jan. 23, 2006


SCOLR Pharma, Inc.
Amex:  DDD
Target 
ID
Target
Validation
Product
Formulation
Lead
Optimization
Pre-
Clinical
Clinical -
Regulatory
Identification
CDT Product Development
Final Product
Partner
Evaluation
Commitment
|
1-2
Months
|
8-14
Months
|
24
36
Mos.
|
Market
Business Model Overview
Markets
New
Chemical
Entity
Rx,
OTC
Drug
-
Exclusive -
New Formulation (NDA)      
-
Generic -
New Use (NDA)
-
BioEquiv. (ANDA)
Dietary
Supplements
Identification Criteria
Partnership Interest
Market Size
Exclusivity Status
Competition
Cost (Dev.       Market)
Time to Market


SCOLR Pharma, Inc.
Amex:  DDD
Peer Group Comparison
UNKNOWN
Polymer
2-3, tablet
12 or more
36 or more
36 or more
36 or more
12-20
18 or more
2-3
Estimated
Manufacturing
Steps
Multiple
manufacturing
steps,
complex
processes
Multi-
Particulate,
erosion,
dissolution
Capsule,
pellets
No
Biovail
Specialized
manufacturing
equipment,
complex
Multi-Layered
Tablet,
Hydrophilic
Matrix,
Swellable
polymer
matrix
Multilayered
tablet
Yes
Skyepharma
Multiple
manufacturing
steps,
complex
processes
Multi-
Particulate,
erosion,
dissolution
Coated
pellets
No
Flamel
Multiple
manufacturing
steps,
complex
processes
Multi-
Particulate,
erosion,
dissolution
Capsule or
coated pellets
Yes
Elan
Labopharm
Andrx
Alza
SCOLR
Special
engineered
polymer,
limited
source,
availability
and
application
Requires
special
manufacturing
with multiple
steps
Complex,
payload
restrictions,
fragile, short
exclusivity
Limitations*
*As compared with  
SCOLR Pharma.
Hydrophilic
Matrix,
Swellable
polymer
matrix
Hydrophilic
Matrix,
Swellable
polymer
matrix
Reservoir
Device,
Osmotic
pump
Hydrophilic
Matrix,
Swellable
polymer
matrix
Mode of Action
Tablet
Tablet
Coated
Bilayer Tablet
Tablet
Dosage Form
No
No
Yes
Yes
Wide
Range
of 
Drugs Tested


SCOLR Pharma, Inc.
Amex:  DDD
Current OTC and Rx Development Targets
$> 4 billion Market
(1)
$ 1 billion
(Global)
-
Animal Study Positive
-
Human Pilot
Study
dosing complete Q-4, ‘05,
-
Data analysis Q-1, ‘06
-
Less
Drug
for
similar
results
(2)
-
Faster absorption
(2)
-
1 tablet vs. 3 every 24 hrs.
-
Simplified Manufacturing
-
Lower Cost
-
Patent Protected
Rx Anti-Nausea
CDT –
ER
Ondansetron
$ 1 billion
(Global)
-
Animal Study
Positive
-
Human Pilot Studies  
completed,
Q-3, 2005
-
Results positive
-
Less
Drug
for
similar
results
(2)
-
Simplified Manufacturing
-
Lower Cost
-
Patent Protected
Rx Osteoporosis
CDT –
IR Raloxifene
$ 1 billion
(U.S.)
-
ANDA Trials Completed,
Q-2,05
-
ANDA Submission planned
2006
-
1/3
size
of
current
OTC
Products
-
Lower Cost
-
Patent Protected
OTC
Decongestant
CDT –
12 hr
Pseudoephedrine
$ 8 billion
(Global OTC
analgesic.)
-
Licensed to WCH, Q4, ‘05
-
1
Extended
Release
OTC
Ibuprofen
-
1 tablet vs. 3 every 12 hrs.
-
Lower Cost
-
Patent Protected
OTC Analgesic
CDT –
12 hr Ibuprofen
Current  Market
Estimate
(1)
Status
Potential Advantages
Application
Lead Products
Notes: 
(1)
Market Data Sources –
IMS, Data Monitor, Company Disclosures, SCOLR
Estimates.
(2)
Based on 2004 Animal Study Findings and Initial 2005 Clinical Results
st
rd


SCOLR Pharma, Inc.
Amex:  DDD
Representative Participant
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0
0.0
5.0
10.0
15.0
20.0
25.0
30.0
Time (hours)
CDT Formulation
CDT Formulation
CDT Formulation
200mg OTC control
600mg Rx control
Current Development Targets -
Ibuprofen
Initial
Ibuprofen
clinical
results
were
favorable
and
led
to
license
of
CDT
applications
for
ibuprofen
products
to
WCH
(Dec.
’05).
Achieves 12 hour extended release in humans.
Shown to be bioequivalent (AUC) to reference OTC and Rx tablet.


SCOLR Pharma, Inc.
Amex:  DDD
Initial Pseudoephedrine Results Positive
Confirms 12 hours Extended Release in Humans
Bioequivalent to OTC Reference Product
STUDY AAI-US-294
LEAST-SQUARES MEAN PSEUDOEPHEDRINE PLASMA CONCENTRATIONS
(N=12)
Under Fasted Conditions
0
50
100
150
200
250
300
350
0
2
4
6
8
10
12
14
16
18
20
22
24
Hours After Dose
TEST
REFERENCE
Current Development Targets -
Pseudoephedrine


SCOLR Pharma, Inc.
Amex:  DDD
48%
59%
80%
Percent of
Variation
from Mean
Value
84%
20048.25
304.09
CDT®
“B”
45 mg
(Non-Optimized)
100%
23952.96
489.24
Evista®
60 mg
(Control)
65%
15455.76
414.14
45 mg Control
(Conventional Tablet)
AUC
0-inf
(picograms/ml)
Calculated Value
Percent of AUC
as compared to
Evista®
Control
Cmax
Formulation
Conclusions:
1.
CDT shown to be a viable alternative to complex solubility and/or permeability
enhancing practices.
2.
Pilot results indicate ability to reduce variability and increase absorption of
raloxifene HCl, as compared to controls. 
Note: Study conducted and results provided by contract clinical research organizations using conventional
methods and practices.
Current Development Targets -
Raloxifene


SCOLR Pharma, Inc.
Amex:  DDD
In Vivo
validation of Amino Acid Platform/Technology
Increased Bioavailability of Ondansetron in rats
Table –Mean Pharmacokinetic Parameters
49.6
81.7
43.0
50.9
2435.5
2450.7
Ondansetron
Control Tablet
3.8
10.8
123.3
105.0
10332.24
7116.0
Ondansetron
Amino Tablet
Std.
Dev.
Mean
Std.
Dev.
Mean
Std. Dev.
Mean
T
max
(min)
C
max
(ng/mL)
AUC
2h
(min*ng/mL)
Formulation
Current Development Targets -
Ondansetron
Initial Human Pilot Study
Dosing Completed Q4, ’05
Data analysis Q1, ‘06


SCOLR Pharma, Inc.
Amex:  DDD
Licensable Portfolio &
Post Menopausal:
In Clinic
Immediate Release & ER tablets
Osteoporosis
-
Raloxifene
Preclinical
24 hour sustained release tablets
Ca channel Blocker
-
Verapamil
Preclinical
24 hour sustained release tablets
Ca channel Blocker
-
Nifedipine
Preclinical
24 hour sustained release tablets
Ca channel Blocker
-
Diltiazem HCl
Preclinical
24 hour sustained release tablets
Beta-Blocker
-
Metoprolol
Preclinical
24 hour sustained release tablets
Beta-Blocker
-
Propranolol
Preclinical
12 hour sustained release tablets
Antilipidemic
-
Niacin
Cardiovascular :
Preclinical
12 hour sustained release tablets
Pain Management
-
Combination
Preclinical
12/24 hour sustained release tablets
Pain Management
-
Tramadol
Preclinical
12 hour sustained release tablets
Pain Management
-
Acetaminophen
Licensed
12 hour sustained release tablets
Pain Management
-
Ibuprofen
Analgesics :
STATUS
DESCRIPTION
INDICATION
NAME


SCOLR Pharma, Inc.
Amex:  DDD
Preclinical
24 hour sustained release tablets
Decongestant
-
Pseudoephedrine
Cough-Cold :
Clinic Done
12 hour sustained release tablets
Decongestant
-
Pseudoephedrine
Preclinical
12/24 hour sustained release tablets
Decongestant/Anti-
histamine
-
Pseudoephedrine/
Loratadine
Preclinical
12 hour sustained release tablets
Decongestant/Pain
Management
-
Combination
Preclinical
12 hour sustained release tablets
Asthma, Bronchodilator
-
Theophylline
Pulmonary :
In Clinic
24 hour sustained release tablets
Nausea
-
Ondansetron HCl
Preclinical
24 hour sustained release tablets
Motion Sickness
-
Dimenhydrinate
Nausea :
Preclinical
12 hour sustained release tablets
Diabetes
-
Metformin
Preclinical
24 hour sustained release tablets
Diabetes
-
Glipizide
Diabetes :
STATUS
DESCRIPTION
INDICATION
NAME
Licensable Portfolio &


SCOLR Pharma, Inc.
Amex:  DDD
Dietary  Supplements:
On Market
12 hour and Once daily tablets
500/400
-Glucosamine/Chondroitin
On Market
12 hour sustained release tablets
300/250/300
-Glucosamine/Chondroitin/MSM
On Market
12 hour sustained release tablets
250/250
-Glucosamine Complex
On Market
(ADM)
Custom designed Pre-blends
various
-Novasoy™
Available
10 hour sustained release tablets
200
-Caffeine
On Market
12 hour sustained release tablets
250
-Niacin
On Market
12 hour sustained release tablets
640 (500)
-Ester C™
On Market
12 hour sustained release tablets
500
-Vitamin C
STATUS
DESCRIPTION
STRENGTH
(mg)
NAME
Marketed or Licensed Dietary Supplements


SCOLR Pharma, Inc.
Amex:  DDD
2006 Objectives
Submission
of
Regulatory
Applications
for
Ibuprofen
and Pseudoephedrine
Identification
of
additional
targets
and
clarify
regulatory
pathway
Continued
development
of
amino
acid
technology
Structure
and
execute
pharmaceutical
agreements  
(including
feasibility,
licensing,
royalty
and
milestone
payments)
Continue
to
expand
and
enhance
presence
as
novel
drug delivery
company/resource
File
additional
patents
Secure
additional
capital


SCOLR Pharma, Inc.
Amex:  DDD
SCOLR Pharma
Opportunity
Large, growing markets
Unique, broadly applicable, patented technology  
platform w/ important benefits
Expanding prescription and OTC pipeline with
several clinical and pre-clinical candidates
Royalty revenues from existing products
Value driving milestones
TM


SCOLR Pharma, Inc.
Amex:  DDD
SCOLR Pharma, Inc.
3625
132
nd
Ave
SE,
#300
Bellevue, WA. 98006
www.scolr.com
TM
CDT®
is a registered trademark of SCOLR Pharma, Inc.
SCOLR & CDT logo and design are trademarks of SCOLR Pharma, Inc.