Transcript - deals.bio

3633 Central Avenue, Ste. I • Hot Springs, AR 71913
Phone: (501) 542-4052 • Fax: (501) 321-2886
E-mail: [email protected] • Website: www.burkepharmaceutical.com
Statements under the Private Securities Litigation Reform Act:
With the exception of the historical information contained in
this release, the matters described herein contain forwardlooking statements that involve risk and uncertainties that may
individually or mutually impact the matters herein described,
including but not limited to its ability to enter into partnering
agreements or raise financing on acceptable terms, successful
completion of clinical development programs, regulatory review
and approval, product development and acceptance,
manufacturing, competition, and/or other factors, some of
which are outside the control of the Company.
o To develop innovative dermatology products
unmet medical needs:
• Develop new indications for approved drugs
• Develop New Delivery Systems
• Develop improved formulations
• Rx or OTC (NDA, ANDA, monograph products)
• Employ 505(b)(2) NDA regulatory strategy
for
Burke Pharmaceuticals, Inc. is dedicated to
delivering innovative dermatology products.
Novel delivery systems, superior formulations
and strategic planning by an experienced team
are priority. Convenient products will address
unmet medical needs for both patients and
physicians.
Privately Held
Incorporated
Shares Outstanding
Capital Infusion
Founded
Number of Employees
Sister Companies
• Arkansas
• N/A
• $3 Million
• 2008
• 6
• Burke Pharmaceutical Research,
Inc.
• The Dermatology Clinic
Management Team
Dr. Dow Stough, MD
Tim Dugan
William Pfister, Ph.D.
• 20+ years practicing
dermatologist
• Founder of three
companies
• Expertise in clinical trials,
product development,
and treatment of skin
diseases
• Managing Director
• Responsible for
operations, financing,
administration
• Early Drug Development
• Scientific Advisor
Dowling B. Stough M.D., F.A.A.D., C.C.T.I.
•
Dr. Stough is the founder and practicing dermatologist of The Dermatology Clinic, P.A. and medical director of
Burke Pharmaceutical Research. Founded in 2000, Burke Pharmaceutical has grown from a small clinical trials
unit within a dermatology practice to a national leader in clinical trials of skin disease. Currently, it employs an
experienced site manager, three clinical coordinators, a full time advanced nurse practitioner and three
physician investigators. Over the last 10 years, Burke Pharmaceutical Research has been involved in over ninety
clinical studies. Dr. Stough has served as the medical director for various pharmaceutical companies conducting
clinical trials, and has conducted multiple investigator-initiated studies.
•
Dr. Stough holds patents on a medical device known as the “Wart Eraser.” He has also been instrumental in
developing other medical devices.
•
Dr. Stough is the founder and past president of the International Society of Hair Restoration Surgery. He was
the author of two leading textbooks dedicated to hair restoration surgery. He has written over 50 scientific
publications and has contributed numerous textbook chapters. He has presented over 180 medical lectures at
scientific meetings and was the recipient of the “Golden Follicle Award” by the International Society of Hair
Restoration Surgery. He is a fellow of the American Academy of Dermatology and holds a certified physician
investigator designation from the Association of Clinical Research Professionals. His interest in dermatologic
drug development is preceded by over 15 years of hands on exposure to clinical trials and protocol
development.
Dowling B. Stough M.D., F.A.A.D., C.C.T.I.

Dr. Stough has always had an interest in research, after his medicine internship at Baptist Hospital in
Memphis, Tennessee; he was involved in research during his dermatology residency at the University of
Arkansas Medical School. Following this, Dr. Stough was accepted into a one year fellowship sponsored
by the American Academy of Cosmetic Surgery. After maintaining an active dermatology practice for 20
years, he recently divested his practice to devote full time attention to clinical research and drug
development. He continues as Clinical Assistant Professor of Dermatology at the University of Arkansas
for Medical Sciences. He maintains active licenses in Arkansas, Florida, Texas, Tennessee, and New York
and continues to see research related patients.

BURKE Pharmaceutical is dedicated to the commercial development of pharmaceutical products and
will draw upon the experience and knowledge gained thru years of research and medical practice. The
targeted products will be physician driven and will fill voids that have not been currently addressed by
other pharmaceutical companies.
Tim Dugan, BS, CCRC

Mr. Dugan has over 11 years of experience in clinical research. He has developed a large database of
contacts with key personnel in the industry. Seven years ago, he became the director of clinical
operations for Burke Pharmaceutical Research. As director, Mr. Dugan handles all the clinical and
regulatory aspects involved in the trial studies; oversees all assisting personnel, negotiates contracts
and budgets, and supervises subject conduct during the trial. He is also instrumental in feasibility
studies in the early development of proprietary drugs initiated by BLU Pharmaceutical.

After graduation from the University of Arkansas, he began his career in clinical trial research at
Physicians Group Research Clinic. While employed, he successfully attained his certificate as a Certified
Clinical Research Coordinator. He then became the regional director of Clinical Operations for Research
Solutions, a national site management organization based in Little Rock, Arkansas. He served as the
director overseeing 10 clinical research sites and managed a dozen research coordinators.

Mr. Dugan received a B.S. in Biology from the University of Arkansas. He also holds certifications from
the Association of Clinical Research Professionals, Certified Clinical Research Coordinator (CCRC), Model
Agreement Group Initiative, and Clinical Research Contract Professional (CRCP).
William R. Pfister, Ph.D.

Ph.D. in Pharmacology and Toxicology.

Senior level executive with 30 years of pharmaceutical company experience in: quality control, technical
service, product development, preclinical and clinical affairs, regulatory affairs & quality assurance,
project management, scientific affairs and business development.

Held senior management positions and supported pharmaceutical product research and development
at Hoffmann La-Roche, American Critical Care, Dow Corning Corporation, PharMetrix Corporation,
Lavipharm Laboratories, NexMed USA, NAL Pharmaceuticals and BLU Pharmaceuticals, Inc.

Expertise in topical, transdermal, parenteral products and controlled release systems. Developed
regulatory strategy and authored and filed numerous INDs and amendments (CMC, preclinical and
clinical), NDAs and eCTDs.

Certified Regulatory Affairs Professional (RAC), Diplomate of the American Board of Toxicology (DABT),
and is author of several patents, publications and books including: “Transdermal and Topical Drug
Delivery Systems, (1997) and “Intraoral Drug Delivery: Molecules to Market” (2005).
Topical Drug Delivery Technology
Patented Wart Eraser
(Device for skin abrasion to enhance skin
permeability)
Dermabrasion device:
510k application.
Used for skin
pretreatment in
combination with
topical medicaments
and antiviral drugs
for treatment of
verrucae
New delivery systems for approved
drugs
Topical
patches
Needle-free and
needle multiple
use injection
devices
Topical
formulations
with
permeation
enhancers
1. Novel Rx Dermatology Products:
Off-Patent Drugs:
• Known Efficacy & Safety
• No Topical Dosage Form
New Drug Products:
505 (b)(2)
• New Route/Indication
• New Dosage Form
2. Improved OTC Dermatology Products:
Off-Patent Drugs:
• Monograph Drugs
• Rx to OTC Switch Drugs
OTC
505 (b)(2)
Monograph
New Drug Products:
• Extended Brand Life
• Extend Patent Life
505 (b) (2) strategy - Between 2005 and 2015 patents expire on drugs having more
than $150 billion in sales!
Novel Topical & Intradermal Injection Delivery Technologies and Devices
Improved products for treatment of:
Recalcitrant and common verrucae
(warts)
Atopic Dermatitis
Product
BURKE901 Wart
Eraser
BURKE402 Hydrogel
Patch Wart Kit
Indication
Dermabrasion
Device
Common
Warts
BURKE601 Cream
Atopic
Dermatitis
BURKE103 NeedleFree Injection
Recalcitrant
Warts
BURKE104 Needle
Injection Pen
Recalcitrant
Warts
Preclinical
Phase 1
Phase 2
Phase 3
Marketed
Wart Eraser
• Dermabrasion medical device: 510k
• Handle and base with abrasive tines
• Provides controlled depth abrasion of warts to
enhance drug penetration
Patent Portfolio: 2 patents & 3
Applications
1. Stough, DB, Wart Removal Method and Device,
US Patent Application No. US 002/0169462A1,
published November 14, 2004.
2. Stough, DB, Wart Removal Method and Device,
US Patent 6,585,742,B2, issued July 1, 2003.
3. Stough, DB, Wart Removal Method and Device,
US Patent Application No. US 004/0138679A1,
published July 15, 2004.
4. Stough, DB, Wart Removal Method and Device,
US Patent 7,056,324,B2, issued June 6, 2006.
5. Stough, DB, Wart Removal method and Device,
US Patent Application No. US 2006/0200174
A1, published September 7, 2006.
Wart Eraser
BURKE402 Hydrogel Patch Wart Kit
• Abrade Skin with Wart Eraser
• Apply patch to wart
• Daily application for up to 6 weeks
BURKE601 Cream
• Co-license agreement signed 1Q2010 between Cypress Pharmaceutical, Inc.
and BLU Pharmaceuticals, Inc. to develop prescription product for atopic
dermatitis
• Pre-IND meeting March 2010
BURKE103 Needle-free Injection
• Reconstitute lyophilized drug with sterile saline
• Needleless intradermal injection
BURKE104 Needle Injection Pen
• Reconstitute lyophilized drug with sterile saline
• Needle intradermal injection
Wart Prevalence
• Cutaneous warts are extremely prevalent with a frequency of
20% in school age children.
• After childhood the prevalence decreases with increasing age
but still maintains over 5% of the population.
• Ranks among the 3 most common dermatosis.
Source: Jean Bologania 2nd edition Dermatology pg. 1183.
Cost of Therapy for Warts
 An analysis which factors efficiency into the cited percent response
rates determined the cost of the varying wart treatments as follows:







Interferon Alpha
Liquid Nitrogen
Squaric Acid
Pulsed-dye Laser
Bleomycin
Candida Antigen
Carbon Dioxide Laser
$ 1,681
$ 1,248
$ 982
$ 690
$ 669
$ 381
$ 356
Source: Comparing Therapy Costs for Physician Treatment of Warts, Journal of Drugs in Dermatology, Dec 2003, Robert J Clemons,
Annette Clemons-Miller, Sandra Marchese Johnson, Susan K Williamson, Thomas D Horn.
OTC Products For Treatment of Warts
Percent Market Share
There are no FDA approved Rx products for treatment of warts
(except anogenital warts) and OTC products are generally ineffective.
There remains an unmet medical need for products that are consumer
friendly, easy to use, painfree and effective for treatment of:
• Common solitary warts on the trunk and extremities (excluding mucous membranes and
genital warts).
• Solitary lesions on the foot or hand.
• Mosaic pattern warts (> 3 lesions grouped closely together).
• Periungual warts (adjacent to the nail fold or distal nail plate).
• Resistant or Recalcitrant warts (warts which have failed to respond to previous
treatments).
Treatment of Warts
Competition Marketed Products
Brand
(Active)
OTC Salicylic
Acid
Preparations
OTC NonRX Freezing
Duct Tape
Rx Freezing
Aldara
(Imiquimod
5% Cream)
Condolyx
(Podofilox
0.5% Gel)
Minor
Surgery
Blenoxane
(Bleomycin)
Cantharidin
Efficacy
Minimal
Somewhat
Minimal
Good
Moderate
(anogenital
warts only)
Moderate
(anogenital
warts only)
Good
Good
Good
Injection
under wart
Topical
Under
Occlusion
NO
NO
Dosage
Forms
Drops, Gels,
Pads, and
Plasters
Temp. of 70 F or - 57
C
Occlusion
“suffocation
”
Temp. of 320 F or 196 C
Cream
Gel
Cutting,
Pairing,
Electrodessication
and
Curettage,
Laser
FDA
Approved
YES
YES
NO
YES
YES
YES
N/A
Intellectual Property and Patent Coverage
Platform
Technology
Formulations
• US Patent: Wart Removal Method and Device
• No. 7,056,324 B2 (Filed June 30, 2003; Issued June 6, 2006):
• Device + Medicament kit
• US Patent Application: Wart Removal Method and Device
• No. 2006/0200174 A1 (Filed May 5, 2006; Publication date Sep. 7,
2006 June 6, 2006):
• Improved Device + Medicament kit
• US Patents to be filed on drug product.
• US Patent Application: PCT to be filed on all US patents.
Advantages Over Marketed Products
• Low Target intradermal dose per wart = 1 unit (1 mg).
• Effective for treatment of recalcitrant warts.
• No approved Rx products for common warts: first line therapy and
superior to OTC products (salicylic acid).
• Current standard of care: surgery, cryoablation, etc.
• “Stone age” treatment, painful, costly, poor patient acceptance.
BLU103/104 Development Studies
• Preclinical Formulation Development & Stability
(Cirrus Pharmaceuticals)
• Human Skin In-Vitro Permeation and Absorption Studies
(Cirrus Pharmaceuticals)
• Rabbit Skin Irritation
(Eurofins – Product Safety Laboratory)
• Rabbit Papilloma Model
(Neil Christensen, PhD – Penn State University)
• Clinical Pilot Study
(Dow Stough, MD – Burke Pharmaceutical Research)
BLU103/104 Development Plan
• Pre-IND meeting in 2Q2010
• File IND in 2Q2010
• Initiate Pilot Phase 2a safety and Efficacy Study 2Q2010
• Initiate Phase 2b safety and Efficacy Study: 3Q2010
• Hold EOP2 meeting with the FDA, 3Q2010
• Initiate one well controlled Phase 3 studies, 4Q2010
• Complete Phase 3, 1Q2011
• File 505(b)(2) NDA, 2Q2011
Conclusions
• In-vitro drug permeation studies on human abraded skin
demonstrate target dermal drug concentrations can be
achieved.
• The dose of drug per wart is approximately 1 mg per
application.
• BURKE101 Patch Kit or injection is expected to have a
superior safety profile.
• BURKE103/104 injection (needle-free or needle) has
compelling clinical data to support efficacy and are on a
parallel development program.
BURKE is Seeking
•Funding for pipeline products
•Co-development partnerships
•Venture capital investment
•Licensing and marketing partners
Hydrogel Patch
BURKE101 Patch
BURKE103 NeedleFree Injection
BURKE104 Needle
Injection
Thank You for Your Attention!