EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1, PRESENTATION exhibit_99-1.htm
*Copyright©2008, SCOLR Pharma, Inc.
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Self Correcting Oral Linear Release -
 Enabling Technologies for Oral Medications
SCOLR Pharma
CDT®  is a registered trademark of SCOLR Pharma, Inc.
SCOLR & CDT logo and design are trademarks of SCOLR Pharma, Inc.
 
 

 
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 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.
§ 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.
 
 

 
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*Kalorama Information 2007 (Cited by In-Pharma
Technologist.com 1-17-2007
SCOLR Pharma: A Differentiated Oral Drug Delivery
Company
§ Proprietary, validated technology - CDT® platform
 § Greater extended-release flexibility
 § Enhanced bioavailability
 § Less complex/cost-effective formulations
§ Develops, licenses and commercializes novel products with
 significant market potential
 § Distributed risk pipeline of internal and partnered targets with
 significant market potential
 § Significant partnerships include
 § Dr. Reddy’s
 § BioCryst Pharmaceuticals
 § Perrigo
 § Market is forecast to increase 48% to reach $52.1 billion in
 revenues by 2010*
 
 

 
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CDT® - A Better Oral Drug Delivery Alternative
§ New generation of less complex, cost-effective tablet/capsule
 formulations
§ Uses standard GRAS ingredients and equipment
§ Based on a portfolio of 5 recently issued and pending patents for
 § Robust, predictable and programmable extended-release
 § Improved solubility/absorption/permeability/consistency
 § Gastro-intestinal (GI) stable formulations
§ Applicable to broad range of drug types and classes and consumer
 products
§ 18 validating clinical studies, n > 550
§ Successful commercialization/scale-up > 250 million tablets shipped
 
 

 
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Important Current Collaborations Expand Pipeline
Potential
§ Dr. Reddy’s Laboratory (DRL) - Collaboration & License Agreement
 § Develop/commercialize CDT-based cardiopulmonary drug
§ BioCryst Pharmaceuticals - Research Collaboration
 § Develop an oral formulation of Peramivir, an injectible drug
 currently under development by BioCryst for the treatment of
 seasonal and life threatening influenza, including the avian flu
§ Perrigo Company- Development and Distribution Alliance
 § 5 CDT-based nutraceutical products currently on the market
 § Largest provider of store brand nutritional and over-the-counter
 (OTC) pharmaceutical products in the U.S.
§ Global Consumer Products Company - Collaboration Extended 12/07
 § Novel application of SCOLR technology for existing global
 consumer product
 
 

 
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SCOLR
(CDT®)
Alza
(OROS®)
Biovail
(FUZE®)
Flamel
(Micropump®)
Pacira
Former Skyepharma
(GeoMatrix®)
Labopharm
(Contramid®)
Wide Range of
Drugs Tested
Yes
(Over 40)
Yes
No
Yes
Yes
No
Mode of Action
Hydrophilic
matrix,
swellable
polymer
matrix
Reservoir
device, osmotic
pump
Multi-particulate,
erosion,
dissolution
Multi-
particulate,
erosion,
dissolution
Multi-layered
tablet,
hydrophilic
matrix,
swellable
polymer matrix
Hydrophilic
matrix,
swellable
polymer matrix
Estimated
Manufacturing
Steps
2-3
18 or more
36 or more
Numerous for
micro-bead
12 or more
Numerous for
polymer
3-4, tablet
Limitations*
*As compared
with SCOLR’s
CDT Matrix
Technology
 
Complex,
payload
restrictions,
fragile, short
exclusivity
Multiple
manufacturing
steps, complex
processes
Multiple
manufacturing
steps, complex
processes
Specialized
manufacturing
equipment,
complex
Special
engineered
polymer, limited
source,
availability and
application
CDT Difference: Broadly Applicable, Flexible, Cost-Effective Sustained Release
 
 

 
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SCOLR
(CDT®)
Elan
(Nanocrystal)
Nano/Micron
Milling
Cydex
(Inclusion
complex)
Altair
(Ti Nanosphere)
Solid
Dispersion
Process
Description
Hydrophilic
matrix, swellable
polymer matrix
Super critical
fluid process, re-
formation of
nanometer sized
drug crystals
Mill the drug
down to the sub-
micron size in
order to increase
surface area for
enhanced
solubility
Cyclodextrin
inclusion
complex.
“Mask” the
insoluble drug by
incorporating
into a soluble
sugar ring
Engineered
nano sphere.
Drug is applied
onto the surface,
or inside
Suspend drug
into inert/soluble
matrix in order to
prevent
agglomeration
during hydration
Estimated
Level of
Complexity
Low
High
High
High
High
Medium
Comments
Simple
granulation,
can be
incorporated
into tablets or
capsules
Complex,
specialized
equipment,
further
formulation
required to
delivery orally
and prevent
agglomeration
Complex,
specialized
equipment,
further
formulation
required to
delivery orally
and prevent
agglomeration
Complex,
specialized
equipment,
further
formulation
required to
delivery orally
and prevent
agglomeration
Complex,
specialized
equipment,
further
formulation
required to
delivery orally
and prevent
agglomeration
Used alone or in
combination.
Often needed to
prevent
agglomeration
CDT Difference: Less Complex Solubility/Absorption Enhancement
 
 

 
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OTC Targets
Indication
Status
Comments
Pre-clinical
Phase I/II
Phase III
12 hr. CDT® - Ibuprofen
Analgesia
     
2 Pivotal - Phase III trials completed.
3rd Pivotal - Phase III trial planned
2008. Additional use and label studies
pending FDA guidance.
12 hr. CDT® - Pseudoephedrine
Cough/Cold
     
ANDA Submission planned in second
half of 2008
Rx Targets
         
Raloxifene - IR
Osteoporosis
     
Two pilot trials completed, Pivotal
trial requirements being evaluated
Ondansetron - 24 hour
Chemo-induced
nausea, vomiting
     
Two pilot trials completed, Pivotal trial
requirements being evaluated
Risperidone - 24 hour
Schizophrenia,
bipolar mania
     
Pilot formulation work completed,
trials pending financing
Rivastigmine - 24 hour
Alzheimer’s Disease
     
Pilot formulation work completed,
trials pending financing
Peramivir (BioCryst) - IR
 
Influenza
   
Animal evaluations completed. Next
stage of collaboration pending
Cardiopulmonary Drug
(Dr. Reddy’s)
  
       
 
                             Confidential                         
Growing OTC & Rx Pipeline with Market > $15 B
 
 

 
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CDT® Dietary Supplements
Extended-Release
Indication
Status
Comments
Formulation
Scale-Up
Marketed
Glucosamine - Chondroitin
Nutritional
Supplement
     
Introduced, Q-1, 2006
Glucosamine - Chondroitin - MSM
Nutritional
Supplement
     
Introduced, Q-4, 2006
Glucosamine Complex
Nutritional
Supplement
     
Introduced, Q-4, 2006
Glucosamine - Chondroitin (Low
Sodium)
Nutritional
Supplement
     
Introduced, Q-4, 2006
Calcium w/ Vitamin D
Nutritional
Supplement
     
Introduced, Q-2, 2007
Niacin
Nutritional
Supplement
     
Licensed, Q-1, 2008
Other(s)
Nutritional
Supplement
       
Consumer Products
         
Undisclosed Application
Confidential
     
Formulation development and
evaluation in progress
Confidential
Consumer Product Pipeline with Markets > $ 2 B
 
 

 
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Innovation: Better Than Brand!
5 Current Extended-Release Products …
§ Sodium Free, Glucosamine Sulfate;
 Glucosamine/Chondroitin & Glucosamine
 Chondroitin/MSM, Calcium w/ Vit. D:
 § Convenient - once/day
 § Active ingredients delivered over extended
 time period
 § Exclusive and patented
CDT-Nutritional Products With Perrigo
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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Platform Consists of Recently Issued CDT® Patents
 § 2000 / US Patent # 6,090,411
 § “Salt Patent” allows for simple two step processing. Uses ionic
 interactions to correct for the limitations in other first generation
 matrix based systems
 § 2002 / US Patent # 6,337,091
 § Dual Polymer Patent” allows for simple production of tablets or
 capsules. Uses ionic and anionic polymers to correct for limitations
 in other biphasic/triphasic systems
 § 2003/2005/2007 US Patents # 6,517,868, # 6,936,275 and # 7,229,642
 § “Amino Acids Patent” allows for simple production of tablets. Uses
 hydrophobic/polar interactions to facilitate solubility and potentially
 permeability
 § 2004/ beyond
 § Additional patent filings and continuations in process
 
 

 
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Lead Products
Application
Potential Advantages
Status
Current
Market
Estimate
(1)
CDT - 12 hour
Ibuprofen
OTC Analgesic
- 1st extended-release OTC
 ibuprofen
- 1 tablet vs. 3 every 12 hrs.
- Lower cost
- Patent protected
- Reacquired rights
- Multiple pilot trials
 completed
- 2 Pivotal trials completed
- 3rd Pivotal trial planned in 2008
- Use and label studies pending
 further FDA guidance
- NDA 505(B)2 planned
$ 8.0 billion
(Global OTC
 analgesic)
CDT - 12 hour
Pseudoephedrine
OTC
Decongestant
- 1/3rd size of current OTC
 products
- Lower cost
- Patent protected
- ANDA trials completed
- ANDA submission planned for
 later half of 2008
$ 1.0 billion
(combined
global market)
Notes: (1) Market Data Sources - IMS, Data Monitor, industry analysts, company disclosures, SCOLR estimates.
Current OTC Development Targets
$9 billion Combined Market
(1)
 
 

 
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Rx products for size reference
only
6 tabs/24 hr
6 tabs/24 hr
2 tabs/24 hr
Not Available in US
SCOLR CDT-Ibuprofen: First 12-hour Extended-Release
Tablets
CDT tablets compared to existing immediate-release tablets
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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SCOLR Pharma, Inc.
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as reported by AAI
Pharma, Inc. Contract
Clinical Research
12hr CDT- Ibuprofen bioequivalent to 3 IR Tablets
§ Pivotal Clinical results - “SCOLR test formulation can be clinically substituted with the reference listed
 drug.”
 
 

 
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SCOLR CDT-Ibuprofen: Demonstrated Stability over 2 years
Undetectable
impurity level
compared to
standard
No detectable impurities
No change in tablet performance
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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N=26 subjects
as reported by
AAIPharma
CDT-Pseudoephedrine: Offers Same Drug Load with
Smaller, More Cost-Effective Tablets
Initial CDT-Pseudoephedrine testing bioequivalent to Sudafed® 12 hour (Reference
 Product)
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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Lead Products
Application
Potential Advantages
Status
Current
Market
Estimate
(1)
CDT - IR Raloxifene
Rx Osteoporosis
- Less drug for similar
 results(2)
- Simplified manufacturing
- Lower cost
- Patent protected
- 2 Human studies completed
- Results positive
- Reviewing clinical
 requirements for regulatory
 approval with FDA
$ 1.0 billion
 (Global)
CDT - 24 hour
Ondansetron
Rx Anti-Nausea
- 1 tablet vs. 3 every 24 hrs.
- Simplified manufacturing
- Lower cost
- Patent Protected
- 2 Human studies completed
- Results Positive
- Reviewing clinical
 requirements for regulatory
 approval with FDA
$ 1.6 billion
 (Global)
BioCryst
Collaboration:
CDT - Neuraminidase
Inhibitor (Peramivir)
Rx Flu Treatment
-Convert current injectible
 product to oral tablet
- Ease of administration
- Consumer compliance
- Broad application
- Initial animal studies completed
- Evaluation in progress
- Next stage of collaboration
 pending
> $1.0 billion
 (Global)
DRL Collaboration:
Undisclosed CDT-
based Rx target
Cardiopulmonary
- Lower cost
- Patent protected
- Other non-disclosed
- Initial formulation completed
- Product transfer initiated
-
Undisclosed
Notes: (1) Market data sources - IMS, Data Monitor, industry analysts, company disclosures, SCOLR estimates.
 (2) Based on animal and clinical study results
Current Rx Development Targets
$ 3.6 billion Combined Market
(1)
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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CDT Enhances Bioavailability
N=34 subjects
as reported by Biovail
Contract Research
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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Once-Daily CDT-Ondansetron Results Comparable to
Multiple Dose Industry Standard
TIME ABOVE MINIMUM PLASMA CONCENTRATION
as reported by Biovail
Contract Research
 
 

 
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Lead Products
Application
Potential Advantages
Status
Current Market
Estimate
(1)
CDT - 24 hour
Risperidone
Rx schizophrenia and
bipolar mania
management
-1 tablet vs. 2 every 24 hrs.
- Simplified manufacturing
- Lower cost
- Patent protected
-Pilot Formulation work
 completed
-Pilot clinical trials pending
 financing
$ 1.8 billion
 (Global)
CDT - 24 hour
Rivastigmine
Rx Alzheimer’s Disease
- 1 tablet vs. 2 every 24 hrs.
- Improved convenience
- Patent protected
- Pilot Formulation work
 completed
-Pilot clinical trials pending
 financing
$ 0.5 billion
 (Global)
       
Notes: (1) Market data sources - IMS, Data Monitor, industry analysts, company disclosures, SCOLR estimates.
New Rx Development Targets
$2.3 billion Combined Market
(1)
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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2008 Strategic Growth Initiatives
§ Complete pivotal trials and label comprehension study
 for 12 hour CDT-Ibuprofen NDA 505(b)2 submission
§ Submit ANDA for 12 hour CDT-Pseudoephedrine
§ Expand “All Day” product suite with Perrigo
§ Advance existing portfolio targets
§ Apply CDT platform to new targets
§ Enter new alliance and partnership agreements
§ Build intellectual property estate/portfolio
§ Complete $4.1 million lease buyout
 
 

 
*Copyright©2008, SCOLR Pharma, Inc.
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Management
§ Daniel O. Wilds, President, CEO and Director, appointed 2003
 § Previously, Chairman, President and CEO of Northwest Biotherapeutics,
 President and CEO of Shiloov Biotechnologies (USA), Adeza Biomedical and
 Medisense, President of Baxter’s Chemotherapy Service, and President and
 COO of Travenol-Genetech, a joint venture between Baxter International and
 Genentech
§  Alan M. Mitchel, Sr. VP Business & Legal Affairs and CLO, appointed 2005
 § Extensive legal, business and corporate finance experience most recently at
 Gray Cary, Former outside counsel for SCOLR
§ Stephen J. Turner, VP Research and Development, CTO, appointed 2003
 § Employed in positions of increasing responsibility at SCOLR since 1999. Built
 SCOLR’s R&D and Information Technology Functions
§ Richard M. Levy, CPA, VP of Finance, CFO, appointed 2006
 § Previously Corporate Controller for Safeco Insurance, CFO for the Specialty
 Finance Segment and Corporate Controller for Washington Mutual Bank,
 Senior Vice President and Controller of Texas operations at Bank of America
§ Tanya M. Raco, Assoc. VP of Regulatory and Quality Affairs, appointed 2006
 § Employed in positions of increasing responsibility at SCOLR since 1997. Built
 SCOLR’s Regulatory and Quality Assurance Functions
 
 

 
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Balance Sheet and Capital Structure
Balance Sheet Data       
March 31, 2008    (In Thousands)
Cash and cash equivalents               $ 9,500
Settlement from lease buyout (April, 2008)    4,100
                Total  $13,600
Working Capital                   $9,500
 
Total Assets        11,300
Total Debt             171
        (In Millions)
Common Shares Outstanding    41.1
Fully - Diluted Shares     48.4
 
 

 
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®
SCOLR Pharma
 Well Positioned for the Future
§ Large, growing markets
§ Unique, broadly applicable, patented technology platform
 with important benefits
§ Expanding prescription and OTC pipeline with multiple
 clinical and pre-clinical candidates
§ Royalty revenues from existing products
§ Value driving milestones
§ Experienced management team
 
 

 
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