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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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437 South Hwy 101, Suite 209
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92075
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Solana Beach, CA
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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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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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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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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 April 2013
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IMPRIMIS PHARMACEUTICALS, INC.
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Dated: April 12, 2013
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By:
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/s/ Mark L. Baum | |
Name: Mark L. Baum
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Title: Chief Executive Officer
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Presentation dated April 2013
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Application
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505(b)(1) NDA
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505(b)(2) NDA
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505(j) ANDA
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New Chemical Entity
(NCE) |
Yes
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Yes/No
(Rely on RLD and Prior Investigation)
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No
(RLD is off patent)
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New Indication
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Yes
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Yes
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No
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New Form/Dose
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Yes
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Yes
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No
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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
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Oral NSAIDs
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Topical NSAIDs
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Efficacy in Acute Soft Tissue Injuries
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Good
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Good
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Efficacy in Osteoarthritis
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Good
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Good
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Incidence of Adverse Events
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High
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Low
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GI Safety (Stomach)
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Poor
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Good
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Hepatic Safety (Liver)
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Poor
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Good
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Renal Safety (Kidney)
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Poor
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Good
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Cardiovascular Safety (Heart)
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Poor
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Good
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Factor
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Impracor™
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Voltaren®
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Delivery Technology
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Patented Accudel™ Micelles
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None; Alcohol
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Per Dose Quantity
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3g
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4g
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Dose Frequency
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BID (2X Daily)
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QID (4X Daily)
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API
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10% Ketoprofen
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1% Diclofenac
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COX Selectivity
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Cox 1
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Cox 2
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Smell
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Neutral
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Insect Repellant
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Tactile
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Smooth
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Greasy
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Capital Structure
March 14, 2013
(Unaudited)
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Percent
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Common Shares
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8,888,250
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82.58%
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Total Restricted Stock Units
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200,000
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1.86%
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Total Options & Warrants - Weighted Avg. Ex. Price $5.49
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1,675,487
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15.56%
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Total Common Shares - Diluted
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10,763,737
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100.00%
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Ketoprofen 20% Patch
(ENDO)
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Ketoprofen Transfersome
Gel, Diractin™ (IDEA) |
Diclofenac Solution
Pennsaid™ (Nuvo) |
Phase
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3
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2/3
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2
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Study Dates
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Aug 2006 - May 2007
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Jul 2003 - Jan 2004
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Jul 2010 - Mar 2011
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# of Subjects/ Age
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309 / above 18 years
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397/ above 40 years
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248 / 18 -80 years
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Regimen/ Duration
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Ketoprofen Patch applied o.d.
4 weeks
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110 mg ketoprofen b.i.d. (n=138)
6 weeks
(1 placebo capsule b.i.d.
100 mg celecoxib capsule b.i.d.)
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1.3 mL applied to front, back and sides of knee
b.i.d. (n=84) Vehicle and placebo controlled
4 weeks
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Selection
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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
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Primary Endpoint
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WOMAC (pain) week 2
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WOMAC (pain ) week 6•
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WOMAC (pain ) week 4
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Secondary Endpoints
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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)•
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WOMAC (stiffness) , WOMAC (function), WOMAC
(pain on walking) - - week 4 Patient global assessment
Pain assessment 11 point scale
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Conclusions
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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. |
Old Phase 3 Trial
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New Phase 3 Trial
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Many sprains and strains trials have failed
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• Acute OA flare (as a pain model) provides a more
reliable population with better chance for separation |
High placebo responses
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• Utilize analgesia-specific proprietary implements and
methodologies to identify placebo responders |
Insufficient monitoring for patient eligibility
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• Invest in trial design and management
• Use only experienced pain trial investigators
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Patients were entered into the ITT up to 72 hours
after injury |
• OA flare model designed for NSAID “wash-out” and
immediate randomization of eligible patients |
People were allowed in if they had 6/10 pain level
over last 24 hours - regardless of pain at baseline |
• OA flare model has defined entry criteria for pain
intensity after NSAID “wash-out” and before randomization |
30 subjects used un-allowed drugs
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• Local laboratory for eligibility (drugs, liver, kidney,
hematology) |
Major dosing compliance problems related to
smaller size of tube orifice vs. applicator card box |
• Provide scales and weigh tubes at any office visit
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Design:
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Randomized, double-blind, placebo-controlled at 26 sites
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Study Population:
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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
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Key Entry Criteria:
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Injury occurred within 72 hours, pain intensity ≥ 60mm on 100 mm Visual Analogue Scale
(VAS); no intake of unallowable medication |
Dosing Regimen:
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Impracor vs. Placebo (Vehicle) cream, 1g t.i.d. x 7 days
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Primary Endpoint:
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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
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ASSETS
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December 31, 2012
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Current Assets
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Cash and cash equivalents
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$
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10,035,615
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Other assets
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670,381
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TOTAL ASSETS
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$
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10,705,996
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LIABILITIES AND STOCKHOLDERS' EQUITY
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Accounts payable and accrued expenses
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$
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709,559
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TOTAL LIABILITIES
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709,559
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Stockholder’s Equity
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Common stock, $0.001 par value, 395,000,000 shares
authorized, |
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6,772,066 shares issued and outstanding
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6,772
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Additional paid-in capital
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34,093,933
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Deficit accumulated during the development stage
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(24,104,268)
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TOTAL STOCKHOLDERS' EQUITY
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9,996,437
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
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$
|
10,705,996
|