Download Transdermal Drug Delivery Opportunity

Rubigo Therapeutics’ Site specific delivery
technology for active ingredients
Investor Presentation – June’12

Dermatology Focus
◦ Treatment of actinic keratosis – a skin condition
that if left untreated can lead to non-melanoma
skin cancer

Unique transdermal delivery platform for
“difficult-to-deliver” drugs
◦ Broad Polymer Intellectual Property

Experienced Life Science Team
◦ Prior successes, deep industry experience

Specialty Pharmaceutical Company
◦ Targeting “approved” drugs that will benefit
from our improved delivery system
2

Actinic Keratosis (AK) is largest segment of
the non-melanoma skin cancer market
◦ 5 Million newly diagnosed each year in US
◦ AK affects up to 58 million in US [Lewin Group]

Imiquimod is a well recognized effective drug
but toxic when over applied
◦ Cream formulations are easy to over apply; with
concentration and dosing issues
◦ +$400 MM annual sales despite product issues
(various sources i.e. 10K, 8Ks)
◦ Reimbursed for management of skin cancer

400 Dermatologists surveyed worldwide, 80%
stated that they would prescribe more
Imiquimod if inflammation could be reduced
◦ 53% indicated they would at least double prescriptions
(Angiogenesis Foundation survey of 400 Dermatologists)
> 2x
More
2x More
Same
50%
More
3
INTELLECTUAL PROPERTY
Film design patent
(US2011/0033515 A1) and two
additional “drug-in-film” patent
applications are the basis for the
working drug delivery prototypes
and current process development.
No Office actions to date but ongoing
corporate discussions support novelty
of approach
FILM MATERIALS
◦Available from multiple sources
4
First site specific drug delivery system delivering a more
appropriate dose of Imiquimod for the treatment of AK
existing drug + enabling delivery system = improved, differentiated product

Imiquimod, off-patent and effective for treating AK

Proprietary Rubigo Film technology
◦ Developed by 3M, available only in cream due to solubility issues
◦ Cream formulations often require high concentration and lack dose control
◦ Currently approved & marketed drug … simpler regulatory path with
reimbursement in place
◦ Sourced from TEVA Pharmaceuticals’ API Division
Enabling technology, stabilizes drug
Novel polymer matrix protected by fresh IP
Controlled dose, avoids overuse by patient
Dose can be terminated by removing film
Film prevents transfer to unintended
areas, people
◦ Simple patient training
◦
◦
◦
◦
◦
5
Transdermal Delivery of Imiquimod
Comparison to Therapeutic Target Amount
• Rubigo Film delivered appropriate dose
• Cream delivered 20X therapeutic target
235
Rubigo’s Film
50
5% Cream
µg/cm2
µg/cm2
Stratum Corneum
Epidermis/Dermis
Therapeutic amount of
Imiquimod required in
the skin:
0.032 µg
0.043
0.649
Imiquimod Delivered at 24 – Hours
Into the Epidermis and Dermal Layers
(Human Cadaver Tissue testing @ Cetero)
6
Transdermal Delivery of Imiquimod
Comparison to Therapeutic Target Amount
•Rubigo Film left no drug on skin at 24 hours
•Cream creates sustained “depot” effect,
resulting in prolonged overdosing
235
Rubigo’s Film
Stratum Corneum
50
µg/cm2
5% Cream
0.328
µg/cm2
0.0
Epidermis/Dermis
Therapeutic amount of
Imiquimod required in
the skin:
0.032 µg
Imiquimod Delivered at 24 – Hours
Into the Epidermis and Dermal Layers
(Human Cadaver Tissue testing @ Cetero)
7
Transdermal Delivery of Imiquimod
Comparison to Therapeutic Target Amount
235
Rubigo’s Film
Stratum Corneum
50
µg/cm2
5% Cream
0.328
µg/cm2
0.0
Epidermis/Dermis
Therapeutic amount of
Imiquimod required in
the skin:
0.032 µg
0.043
0.649
Imiquimod Delivered at 24 – Hours
Into the Epidermis and Dermal Layers
(Human Cadaver Tissue testing @ Cetero)
8
$1.4B WW
Market
Opportunity
15-25%
Worldwide
Incidence: 8-10 million/yr
Prevalence: 75-100 million
Surgical Procedures
(Cryosurgery, chemical peels, curettage)
Positives
• Short treatment time
• If fully treated, high cure rate
Negatives
• Cryosurgery, a blind treatment leaving
cancer seeds allowing recurrence
• Scarring
• Poor cosmetic outcome i.e.
discoloration
• Pain
• Expensive
Topical Cream Therapies
Positives
• Good cosmetic effects
• High cure rate
• Treat large areas
• Convenience
• Lower cost
Negatives
• Longer treatment time
• Adverse site reactions
• Can be painful
• May require patient to stay out of the sun
for 30-45 days
Rubigo IQ Film will address
these negative factors.
10
Comparables
•Fougera and Perrigo
Pharma 1st Year Sales of
Imiquimod Generic Cream,
$107MM each
•Hisamitsu Pharmaceutical
acquired Noven in 2009 :
$428M, a 4x on trailing
sales
11



The company is soliciting $1.5 million thru a
Convertible Loan
25% discount to Series A Equity Round
Proceeds to fund 1st Tranche leading to FIH
Phase I Development – $3.5M Seed Raise
1st Tranche: $1.5M
•Establish cGMP (Mfg Partner)
•Pre-clinical/IND testing
•FDA Pre-IND Meeting
2nd Tranche: $2M
•Complete First in Human Study
• IND Submission
Phase II – Phase I/II and OUS Launch
•Series A Financing - $10M
•Phase I and II of FDA IND
•CE Mark
•Q4’14 OUS Commercialization
License/Phase III – US launch
•Series B Financing/License -$10M
•Complete Phase III
•US Approval and Launch
•Follow on Indications &/or
Applications
12
Employees
Board of Directors and Advisors
Kevin Nickels, CEO (Board)
• CEO, serial life science entrepreneur
• +25 years, retail, institutional capital, M&A
Yogesh Dandiker, PhD (Board)
• Drug Discovery and Generic Pharmaceutical
History
Stan Harpstead, CTO (Board)
• Product Development
• Biotechnology
Post Financing:
Project Manager
Experience in Pharma Industry
Q3’13
Supply Chain Manager
CFO/Controller
QA Manager
Steve LeVahn (Board)
• Investor and former-CEO Omni Track Medical
William Li, MD (Head of Medical Advisors)
• President, Angiogenesis Foundation
Rob Kirsner, MD PhD
• Dermatologist, U of Miami
Vince Li ,MD
• Dermatologist, Brigham and Women’s
Dick Miller, PhD
• Ex-3M Scientist and Inventor of Imiquimod
Operational Partners
Product Manufacturing
• Experienced drug-in-film casting company
with successful FDA history
Regulatory Strategy and Application
• Experienced 505 (b)(2) Drug Regulatory
Consultant
Clinical Study Contract Research Organization
(CRO)
• Experience in Drug and Outside USA Clinical
Studies
Rachel Clark, MD (proposed)
• Dermatologist, Brigham and Women’s
Key Suppliers/Distribution Partners
Imiquimod – TEVA Pharmaceuticals
Polymers - Lubrizol & Dow Chemical
Distribution - TBD
Rubigo
Platform
Technology
Expanded
Indications for
Imiquimod Film
for other forms
of Skin Cancer
•Squamous Cell
Carcinoma (SCC)
•Basal Cell Carcinoma
(BCC)
Other
Indications for
Imiquimod
Film
•Pre-Biopsy Assessment
•Vaccine Adjuvant
•Etc.
Initial Indication:
Actinic Keratosis
(AK)
Other Drugs
loaded into
Film
•Local pain (lidocaine)
•Skin fungus (terbinafine)
•Etc.
14

Proprietary drug delivery platform

Significant initial clinical dermatology opportunity

Compelling value creation for a modest
investment in a life science company offering
Early Knowledge to Impact Life

Experienced Life Science Team
Thank you for your consideration
[email protected]
612.309.5305
15