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. (Feb. 15, ’06)
Approx. $235 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
12 hour Phenylephrine
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, results positive
Rx –
Other Rx Targets In Development
Fenofibrate
12 hour Gabapentin
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): 
$1.32 billion
Biovail (NYSE: BVF)         
$4.00 billion
Depomed
(Nasdaq: DEPO)
$259.5 million
Flamel
(Nasdaq: FLML):   
$506.8 million
Impax
(Nasdaq: IPXLE):     
$687 million
Pozen
(Nasdaq: POZN):
$499 million
Skyepharma
(Nasdaq: SKYE) 
$483.5 million
Approx. Valuations @ 12:00 on Feb. 16, 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 Development Targets
$
9
billion
Combined
Market
(1)
-
Initial formulation work
completed
-
Clinical trials planned 2006
-
Lower Cost
-
Patent Protected
OTC
Decongestant
CDT –
12 hr
Phenylephrine
$ 1 billion 
combined market
(U.S.)
-
ANDA Trials Completed,
Q-2,05
-
ANDA Submission planned
2006
-
1/3rd
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
-
1st
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


SCOLR Pharma, Inc.
Amex:  DDD
Current Rx Development Targets
$
3.9
billion
Combined
Market
(1)
$ 1.5 billion
(Global)
-
Animal Study Positive
-
Human Pilot
Study
dosing complete Q-4, ‘05,
-
Results positive
-
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
$ 0.8 billion
(Global)
-
Formulation work in
progress.
-
Human studies planned
2006.
-
Less
Drug
for
similar
results
-
Simplified
Manufacturing
-
Alternative
to
nanocrystalization
-
Lower
Cost
-
Patent
Protected
Rx Cholesterol
Management
(Hypercholesterolemia)
CDT-
IR
Fenofibrate
$ 0.6 billion
(Global)
-Formulation work in
progress.
-
Human studies planned
2006.
-
Improve
absorption
-
1
tablet
every
12
hrs.
-
Simplified
Manufacturing
-
Lower
Cost
-
Patent
Protected
Rx Neural Pain
CDT-
ER
Gabapentin
$ 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
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


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
Prototype 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.
N=10 subjects


SCOLR Pharma, Inc.
Amex:  DDD
Initial Pseudoephedrine Results Positive
Confirms 12 hours Extended Release in Humans
Bioequivalent
to
Sudafed®
12
hour
(OTC
Reference
Product)
Current Development Targets -
Pseudoephedrine
MEAN PSEUDOEPHEDRINE PLASMA CONCENTRATIONS
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
N=12 subjects


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
N=20 subjects


SCOLR Pharma, Inc.
Amex:  DDD
Current Development Targets -
Ondansetron
-1
-0.5
0
0.5
1
1.5
2
2.5
3
0.00
0.10
0.20
0.30
0.40
0.50
Time (hours)
8mg Means
A means
B means
C means
Initial  CDT Ondansetron clinical results  were favorable (non-optimized)
Results indicate potential for higher blood levels within the first 30 minutes,
as compared to Zofran®
8mg Rx tablet.
N=30 subjects


SCOLR Pharma, Inc.
Amex:  DDD
Current Development Targets -
Ondansetron
Initial  CDT Ondansetron clinical results  were favorable (non-optimized)
Results indicate potential for sustained release, as compared to
Zofran®
8mg Rx tablet.
Amino Acid CDT vs. Zofran 8mg Geometric Means
0
10
20
30
40
50
60
0.00
5.00
10.00
15.00
20.00
Time (hours)
8mg Means
B means
C means
N=30 subjects


SCOLR Pharma, Inc.
Amex:  DDD
Licensable Portfolio &
Preclinical
Lower dose equivalent to Tricor®
Cholesterol
Management
-
Fenofibrate
Preclinical
12 hour sustained release tablets
Neural Pain
-
Gabapentin
Post Menopausal:
In Clinic
Lower dose equivalent to Evista®
Osteoporosis
-
Raloxifene
Preclinical
Compared to Covera-HS®
Ca channel Blocker
-
Verapamil
Preclinical
Compared to Procardia®
Ca channel Blocker
-
Nifedipine
Preclinical
Compared to Dilacor®
Ca channel Blocker
-
Diltiazem HCl
Preclinical
Compared to Toprol
XL®
Beta-Blocker
-
Metoprolol
Preclinical
Compared to Inderal
LA®
Beta-Blocker
-
Propranolol
Preclinical
Equivalent to Niaspan®
Antilipidemic
-
Niacin
Cardiovascular:
Preclinical
12/24 hour sustained release tablets
Pain Management
-
Tramadol
Licensed
12 hour sustained release tablets
Pain Management
-
Ibuprofen
Analgesics:
STATUS
DESCRIPTION
INDICATION
NAME


SCOLR Pharma, Inc.
Amex:  DDD
Suspended*
Equivalent to Sudafed®
24 hour
Decongestant
-
Pseudoephedrine
Cough-Cold:
Clinic Done
Equivalent to Sudafed®
12 hour
Decongestant
-
Pseudoephedrine
Preclinical
12 hour sustained release tablets
Decongestant
-
Phenylephrine
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
Equivalent to Glucophage®
XR
Diabetes
-
Metformin
Preclinical
Equivalent to Glucotrol®
XL
Diabetes
-
Glipizide
Diabetes:
STATUS
DESCRIPTION
INDICATION
NAME
Licensable Portfolio &
*pending market review


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,
#400
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.