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Delaware
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001-35814
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45-0567010
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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12626 High Bluff Dr. Ste 150
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San Diego, CA
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92130 | |
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(Address of principal executive offices)
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(Zip Code)
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N/A
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(Former name or former address if changed since last report.)
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o
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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o
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Presentation dated July 2013
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IMPRIMIS PHARMACEUTICALS, INC.
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|||
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Dated: July 23, 2013
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By:
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/s/ Andrew R. Boll | |
| Name: Andrew R. Boll | |||
| Title: Vice President, Accounting and Public Reporting | |||
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Presentation dated July 2013
|






|
Application
|
505(b)(1) NDA
|
505(b)(2) NDA
|
505(j) ANDA
|
|
New Chemical Entity
(NCE) |
Yes
|
Yes/No
(Rely on RLD and Prior Investigation)
|
No
(RLD is off patent)
|
|
New Indication
|
Yes
|
Yes
|
No
|
|
New Form/Dose
|
Yes
|
Yes
|
No
|
|
Required Data for
Approval |
• Complete Pharmacology
• Complete Preclinical
Safety, including long term carcinogenicity in 2 species • Complete analytical
development and quality manufacturing • Complete Phase 1-3
clinical trials |
• Data from published literature
• FDA findings on efficacy/safety of
approved drug/formulation • Studies to support change
• Dermal/Eye Safety (topical drugs)
• Clinical Efficacy/Safety
• CMC (3 registration batches with
stability data) |
• Bioequivalence
|







|
Therapeutic
Area |
Compound
|
Indication
|
Market Analysis
|
|
PAIN
|
IPI110
Impracor™, Ketoprofen 10%
Cream |
Sprains, Strains and
Joint Pain |
$10B US NSAID Market
Transitioning to Topicals due to high incidence of AEs
Voltaren Gel has 75% Rx Share
Topical NSAID market may
exceed $1B by 2015
|
|
OPHTHALMOLOGY |
IPI004**
Corticosteroid + Antibiotic |
Prophylaxis of Post-
Operative Complication following Cataract, Glaucoma, and Retinal Surgery |
19M Global Cataract Surgeries (2011); $200-
$300/drugs/US surgery Growing Market due to Aging Pop. and Demand to have
surgery at an earlier age Combination (single injection) will minimize risk for injury
and infection versus multiple injections |
|
WOUND HEALING
|
IPI120
Tranexamic Acid + Antibiotic
|
Topical wound care
treatment of genetic and acquired bleeding disorders |
$9B Global Bleeding and Clotting Disorders Market
$17B US Wound Care Market
7M American suffering from chronic wound, annually
|
|
** Imprimis has an exclusive option and right to negotiate to acquire this drug formulation and intellectual property based on substantially prenegotiated terms. |
|||



|
Factor
|
Impracor™
|
Voltaren®
|
|
Delivery Technology
|
Patented Accudel™ Micelles
|
None; Alcohol
|
|
API
|
10% Ketoprofen
|
1% Diclofenac
|
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COX Selectivity
|
Cox 1
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Cox 2
|
|
Smell
|
Neutral
|
Insect Repellant
|
|
Tactile
|
Smooth
|
Greasy
|





|
|
Capital Structure
March 31, 2013
(Unaudited) |
Percent
|
|
Common Shares
|
8,888,250
|
82.72%
|
|
Total Restricted Stock Units
|
200,000
|
1.86%
|
|
Total Options & Warrants - Weighted Avg. Ex. Price
$5.42 |
1,656,258
|
15.42%
|
|
Total Common Shares - Diluted
|
10,744,508
|
100.00%
|
|
|
|
|












|
|
Ketoprofen 20% Patch
(ENDO)
|
Ketoprofen Transfersome
Gel, Diractin™ (IDEA) |
Diclofenac Solution
Pennsaid™ (Nuvo) |
|
Phase
|
3
|
2/3
|
2
|
|
Study Dates
|
Aug 2006 - May 2007
|
Jul 2003 - Jan 2004
|
Jul 2010 - Mar 2011
|
|
# of Subjects/ Age
|
309 / above 18 years
|
397/ above 40 years
|
248 / 18 -80 years
|
|
Regimen/ Duration
|
Ketoprofen Patch applied o.d.
4 weeks
|
110 mg ketoprofen b.i.d. (n=138)
6 weeks
(1 placebo capsule b.i.d.
100 mg celecoxib capsule b.i.d.)
|
1.3 mL applied to front, back and sides of knee
b.i.d. (n=84) Vehicle and placebo controlled
4 weeks
|
|
Selection
|
Diagnosis of knee (unilateral or bilateral),
CRO: PPD |
Morning stiffness < 30’, crepitus, at least 3 on
Likert’s 5 point scale, not on NSAIDS |
Patients using NSAIDs underwent a 1-week
washout This was a non-flare study
|
|
Primary Endpoint
|
WOMAC (pain) week 2
|
WOMAC (pain ) week 6•
|
WOMAC (pain ) week 4
|
|
Secondary Endpoints
|
Pain Intensity/ relief (diary)
WOMAC (function), Rescue Medication,
quality of sleep, lost days of work. Pat./Phys. global assessment |
WOMAC (function)-week 6.
Patient global assessment (5 Point Likert)•
|
WOMAC (stiffness) , WOMAC (function), WOMAC
(pain on walking) - - week 4 Patient global assessment
Pain assessment 11 point scale
|
|
Conclusions
|
ITT Primary Endpoint met: Significant
differences vs placebo (p=0.014). All secondary endpoints met. Previously two Phase 3 sprain/strain trials failed, program discontinued. ENDO 10Q 2007 |
WOMAC pain LS mean reduction - 18.2 (-22.1 to -
14.3), -20.3 (-24.3 to -16.2) and -9.9 (-13.9 to - 5.8) osteoarthritis (p <0.01) All WOMAC subscale scores were normalized to
a scale of 0 to 100 by dividing the sum subscale score by the number of questions of each score. Ann Rheum Dis. 2007; 66(9): 1178-83. Swissmedic approval based on single study |
WOMAC pain reduction (5-Point Likert) from
baseline (-3.9 [- 4.8 to -2.9]) compared with vehicle -control solution (-2.5 [- 3.3 to -1.7]; p = 0.023) or the placebo solution (-2.5 [-3.3 to -1.7]; p = 0.016). CMAJ • AUG. 17, 2004; 171 (4) 5 Phase 3 trials have achieved all 3 primary end
points in OA. |

|
Design:
|
Randomized, double-blind, placebo-controlled at 26 sites
|
|
Study Population:
|
Efficacy, n = 361
Uncomplicated acute soft tissue injuries
Ankle (n=97), Shoulder (n=87), Knee (n=59), Wrist (n=57), Elbow (n=30), Calf/Anterior Tibialis
(n=11), Hamstring/Quadriceps (n=8), Forearm (n=5), Biceps/Triceps (n=3), Hand (n=3) Safety, n = 364
Ranging in age from 18 - 75 years
|
|
Key Entry Criteria:
|
Injury occurred within 72 hours, pain intensity ≥ 60mm on 100 mm Visual Analogue Scale
(VAS); no intake of unallowable medication |
|
Dosing Regimen:
|
Impracor vs. Placebo (Vehicle) cream, 1g t.i.d. x 7 days
|
|
Primary Endpoint:
|
Change from baseline in pain intensity during daily activities on Day 3 office
visit (+1, +2 days) with 100 mm VAS measurement |
|
Secondary
Endpoints: |
• Change from baseline in three times daily pain intensity immediately prior to medication
• Various other treatment satisfaction and safety assessments
• Pharmacokinetics in subset of patients
|





|
ASSETS
|
|
March 31, 2013
|
||
|
Current Assets
|
|
|
||
|
|
Cash and short term investments
|
$
|
19,029,031
|
|
|
|
Other assets
|
|
217,540
|
|
|
|
|
TOTAL ASSETS
|
$
|
19,246,579
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
||
|
|
Accounts payable and other accruals
|
$
|
848,549
|
|
|
|
|
TOTAL LIABILITIES
|
|
848,549
|
|
Stockholder’s Equity
|
|
|
||
|
|
Common stock, $0.001 par value, 395,000,000 shares authorized,
|
|
|
|
|
|
|
8,888,250 shares issued and outstanding
|
|
8,888
|
|
|
Additional paid-in capital
|
|
43,958,891
|
|
|
|
Deficit accumulated during the development stage
|
|
(25,569,749)
|
|
|
|
|
TOTAL STOCKHOLDERS' EQUITY
|
|
18,398,030
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
19,246,579
|