Transcript PuraMed-Power-Point

LipiGesic™
Presentation
November 2011
1
Forward Looking Statements
Except for the historical information presented, the matters disclosed in this
presentation may include “forward-looking statements.” These statements represent
the company’s current judgment on the future and are subject to risk factors and
uncertainties that could cause actual results to differ materially. To the extent that
there are any statements that can be construed as forward looking, they should be
considered in the context of all of our previous releases and federal filings.
NOTE: This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any security. There
shall be no sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be
unlawful prior to qualification under securities laws of such state or jurisdiction.
2
Who is PuraMed BioScience ?
•
Engaged in the development and marketing of a line of revolutionary, new, nonprescription medicines targeting major consumer health needs including the treatment
of migraine headaches, insomnia and tension-type headaches.
•
PuraMed products comply with all FDA and other regulatory requirements associated
with the manufacturing and marketing of its products.
•
PuraMed BioScience, Inc. emphasizes science as the key to success. The Company has
engaged leading researchers to conduct human trials as well as In-Vitro studies.
•
On September 20, 2011 PuraMed announced that it has achieved national distribution
with a major US retail chain.
3
Intellectual Property
Clinical Studies: Although not required, PuraMed is committed to conducting
scientific studies to provide independent third party validation to its claims.
•
PuraMed has conducted studies that include:
 In-Vitro – Test tube or Petri dish studies.
 In-Vivo – Human trials.
•
Patent – An initial patent on the LipiGesic™ M product is pending.
•
As a result of the In-Vitro clinical work, PuraMed expects to further bolster its
intellectual property by creating a new proprietary ingredient.
4
The Company
•
To build a substantial and profitable business rapidly, beginning with three products
developed by its founders, with markets collectively worth well over $6 billion in
the U.S.
•
To establish a leadership position in the highly fragmented non-prescription market by
introducing a “new kind of product line.” Our product line consists of effective
alternative remedies for common ailments, marketed to the masses.
The Company intends to launch its first two retail products then leverage that
success to ultimately become a leader in the non-prescription medicine
marketplace.
5
Product Pipeline: LipiGesic™ M, LipiGesic™ H
and LipiGesic™ PM
•
Are all effective alternative to both non-prescription & prescription products
currently available.
•
Have essentially no competition in the ‘alternative’ category.
•
Will compete effectively against established ‘standard’ (non prescription &
prescription) products - we’ll prove it.
•
Address predictably recurring ailments.
• No seasonality.
• The same consumers continue to suffer.
• Each customer becomes potentially long-term, substantial, recurring revenue.
6
What is Sublingual Delivery?
More Than a Product – It’s a Platform
Sublingual delivery is efficient and superior to most other delivery systems.
Sublingual Delivery means “under the tongue.”
•
Faster than pills. The capillaries under the tongue are very close to the surface enabling very
fast absorption and action.
•
Avoids the “first pass” effect. Since the drug is absorbed under the tongue it does not get
broken down by the stomach and liver as in the case of pills and liquids that are dosed orally.
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Reaches Effective Blood Levels Fast
TIME TO PEAK PLASMA CONCENTRATION
100
80
60
MINUTES
40
20
0
ORAL
DERMAL
SUBLINGUAL
Source: PDR- Physicians Desk Reference 18 Edition 1997, Page 676
8
PuraMed Market Strategy (Balance of 2011)
Commence public relations campaign utilizing our first clinical study.

Clinical trials help to overcome consumer and retailer skepticism.

Positive clinical results provide third party validation of the products efficacy.

The value of the publicity surrounding the release of data can be substantial. Quigley
Corporation, the manufacturer of Cold-Eeze®, estimates they received publicity equal
to $30 million in free advertising in the year they released the trial results from the
Cleveland Clinic.

Provide evidence to substantiate product claims to retailers and government agencies.
9
PuraMed Market Strategy (Balance of 2011)
Public relations efforts will consist of:
 Social marketing campaign
 Medical detailing and sampling
 Continuing Medical Education (CME) program for
doctors and pharmacists
 Medical conference participation for MDs, DOs, Nurse
Practitioners and Physician Assistants
 Celebrity endorsements
10
PuraMed Marketing Strategy (Balance of 2011)
Sales and Advertising Efforts:
 Resume direct response print advertising campaign
 Launch LipiGesic M into U.S. retail chain
drug (24,000 stores)
 Finalize and implement celebrity endorsement program
11
Examples of Successful Launches of Naturally
Derived
Non-Prescription Medications
Quigley Corporation (Nasdaq: QGLY): manufacturers of “Cold-Eeze®”
•
Annual factory sales rose to $70 million within 24 months of launch
•
Market capitalization achieved $300M
Matrixx Initiatives (Nasdaq: MTXX): manufacturers of “Zicam®”
•
Formerly GumTech International, they simply reformatted the zinc-gluconate lozenge
into a nasal application and achieved annual sales of over $50 million within 24
months with current annual sales of $96 million
•
Market capitalization achieved $200M
12
LipiGesic™ M
For:
•
•
•
Acute relief from migraine headaches and associated
symptoms.
Fast acting: sublingual.
Contains Feverfew (3X) and Ginger (2X).
13
The LipiGesic M Study entitled:
A Double-Blind Placebo-Controlled Pilot Study of
Sublingual Feverfew and Ginger (LipiGesic™M) in
the Treatment of Migraine
authored by: Roger K Cady, MD, Jerome Goldstein, MD, Robert
Nett, MD, Russell Mitchell, Rebecca Browning,
has been published as of June 2, 2011
in the journal:
Headache: The Journal of Head and Face Pain.
14
Key US Migraine Market Statistics and Facts
How bad is the problem?






Approximately 50 million people in the US suffer from migraine headaches
Migraine headaches are the most costly brain disorder in the US
Migraine headaches cost the US economy over $31 billion in 2010.
Over 2 million children in the US suffer from migraines and there are no
prescription medications approved for use in children.
Migraine sufferers average 35 attacks per year. That averages out to be 1.65
billion events per year.
Migraine headaches last from 4 to 72 hours.
15
Key US Migraine Market Statistics and Facts
Who gets migraine headaches?






Approximately 18% of women and 6% of men suffer from migraine
headaches.
The primary age for sufferers is between 18 and 45 years.
Migraines generally subside with age, starting after 50.
There is a strong genetic link between sufferers. A person who suffers from
migraines has a 75% chance of having an immediate family member who also
suffers.
Less than half of all sufferers have ever been diagnosed by a medical
professional.
Studies have recently shown that veterans coming home from the wars in
Afghanistan and Iraq have twice the occurrence rate versus the general
population.
16
Key US Migraine Market Statistics and Facts
How effective are current treatments?




57% of migraine sufferers rely exclusively on non-prescription
treatments.
The lowest cost of the generic form of the leading prescription
treatment is $20 per pill and two pills are generally used. Other
treatments can cost up to $150 per treatment.
The side effects associated with the current triptan treatments can be
severe and triptans are contraindicated for many sufferers.
The current treatments have a strong association with rebound
headaches.
17
HOW DO WE STACK UP VERSUS
THE
PRESCRIPTION DRUGS?
18
How do we stack up versus the
prescription drugs?
Mean Relief at 2 Hours
80%
72%
70%
60%
64%
63%
63%
61%
59%
55%
50%
40%
30%
20%
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19
How do we stack up versus
the prescription drugs?
Pain Free at 2 Hours
50%
45%
40%
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32%
35%
30%
25%
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18%
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20
How do we stack up versus the
prescription drugs?
Average Monthly Costs
IF 2 MIGRAINES / MONTH AND TAKE 2 DOSES PER ATTACK, OVER 24 HOURS
$600
$500
$400
$300
$200
$100
$0
56
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21
How do we stack up versus the
prescription drugs?
Average Yearly Costs
IF 2 MIGRAINES / MONTH AND TAKE 2 DOSES PER ATTACK, OVER 24 HOURS
$7,000
$6,000
4
$5,
72
$5,000
$4,000
$3,000
$2,000
$1,000
5
$3,
52
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$3,
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,
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22
COMPARISON
LipiGesic M vs. 100mg Sumatriptan
NUMBER ONE SELLING PRESCRIPTION DRUG
23
Effective
LipiGesic M Provides Superior Relief at 2 Hours
Relief at 2 Hours
64%
65%
64%
63%
62%
61%
60%
59%
59%
58%
57%
24
56%
Sumatriptan 100mg
LipiGesic M
Effective
LipiGesic M Provides 10% Greater Pain Free Outcomes
2 Hours Pain Free
33%
32%
32%
31%
30%
29%
29%
28%
27%
25
Sumatriptan 100mg
LipiGesic M
Effective
LipiGesic M Reduces the Rate of Headache Recurrance by Almost 50%
Headache Recurrance Rate
35%
30%
30%
20.40%
25%
20%
15%
10%
5%
0%
Sumatriptan 100mg
LipiGesic M
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Effective
In addition to pain relief, LipiGesic M has also been shown to
relieve other sympoms commonly associated with migraine
headaches including:
 Pulsating character of the headache
 Worsening of headache with activity
 Light sensitivity
 Sound sensitivity
 Nausea
27
Less Expensive
Average Monthly Costs
IF 2 MIGRAINES / MONTH AND TAKE 2 DOSES PER ATTACK, OVER 24 HOURS
$160.00
$148.00
$140.00
$120.00
$100.00
$80.00
$80.00
$60.00
$40.00
$10.00
$20.00
$0.00
Sumatriptan 100mg
Imitrex
Sumatriptan 100mg
Generic
LipiGesic M
28
Less Expensive
Average Annual Costs
IF 2 MIGRAINES / MONTH AND TAKE 2 DOSES PER ATTACK, OVER 24 HOURS
$2,000.00
$1,776.00
$1,800.00
$1,600.00
$1,400.00
$1,200.00
$960.00
$1,000.00
$800.00
$600.00
$400.00
$120.00
$200.00
$0.00
Sumatriptan
100mg Imitrex
Sumatriptan
100mg Generic
LipiGesic M
LipiGesic M will cut the cost of treatment by at least 75%.
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LipiGesic M Side Effects
LipiGesic M provides a side-effect profile
similar to placebo.
LipiGesic M was well tolerated and no
serious adverse events were reported.
30
Triptan Side Effects
Irritation of the Inside of the Nose
Taste Problems
Feel Like Throwing Up
Throwing Up
Signs and Symptoms at Injection Site
Drowsiness
Dizzy
Serotonin Syndrome – Adverse Drug
Reaction
Poor Vision
Heart Attack
Disease of Inadequate Blood Flow to the
Heart Muscle
Rapid Ventricular Heartbeat
Ventricular Fibrillation
Stiff Neck
Seizures
Chest Pain
Chest Tightness
Difficulty Swallowing
Stomach Cramps
Life Threatening Allergic Reaction
Coronary Artery Spasm
Problems With Eyesight
Sinus Irritation and Congestion
Sore Nose
Pain in the Jaw Area
Mouth Irritation
Sore Tongue
Scaly Oily Skin Problem Primarily on Face
and Scalp
Muscle Weakness
Muscle Stiffness
Muscle Pain
Cramps
Low Energy
Excessive Sweating
Temporary Redness of Face and Neck
Numbness and Tingling
Anxious
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LipiGesic M Contraindications
You should not take LipiGesic M if:


You are pregnant or breast feeding
If you have a known allergy to any of the ingredients
32
Triptan Contraindications
You should not take triptans if you have or have had:





Coronary artery disease (with or without angina)
A previous heart attack
Peripheral vascular disease
Uncontrolled high blood pressure
“Complicated” migraines, such as those with temporary weakness in an arm or leg, vertigo, or
confusion.
You should take with caution if you are:



Older than 40, for men
Older than 50, for women
Currently taking certain antidepressants (talk with your doctor)
Or if you:







Have diabetes
Have a family history of early heart disease or stroke
Have high cholesterol
Are in menopause
Are obese
Are pregnant
Smoke
33
Easy to Use
LipiGesic M is a non-prescription drug,
which allows for easy access.
 LipiGesic M is pre-measured for accurate
dosing.
 LipiGesic M is small and portable.
 LipiGesic M has no known drug
interactions.

34
Summary
Comparison of
LipiGesic M vs. Sumatriptan 100mg
More effective
 Superior Safety Profile
 Cuts treatment costs by at least 75%
 Available without a prescription

35
Summary
•
•
•
•
•
•
•
Migraine
Over 50 million suffer.
1 billion + events/yr.
Majority rely on non
prescription.
• Marginally
effective.
• Significant side
effects.
No ‘alternative’
competition.
Bests ‘standard’
products.
Recurring, non-seasonal.
Unique delivery
platform.
•
•
•
•
•
•
•
Tension
Over 102 million suffer
from chronic and
episodic tension-type
headache.
1 billion events/year.
Majority rely on non
prescription.
• Marginally effective.
• Significant side
effects.
No ‘alternative’
competition.
Bests ‘standard’ products.
Recurring, non-seasonal.
Unique delivery platform.
•
•
•
•
•
•
•
Insomnia
70 million suffer.
5 billion events/yr.
Majority rely on nonprescription.
• Marginally
effective.
• Significant side
effects.
No ‘alternative’
competition.
Bests ‘standard’
products.
Recurring, non-seasonal.
Unique delivery
platform.
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Research and Development
•
PuraMed Bioscience, Inc. emphasizes science as the key to success.
•
PuraMed utilizes Hillestad Pharmaceuticals, Inc. a fully licensed and FDA registered
prescription and non-prescription drug contract manufacturing facility to produce all
of its formulations.
•
PuraMed has currently targeted several key research organizations and leading
researchers that it has previously worked with on prior projects.
37
Management Background
Russ Mitchell, Chairman and CEO
•
Formerly served as an Officer and/or Director of several publicly traded companies.
•
Pioneer in establishing the marketing value of clinical trials to demonstrate the
effectiveness of OTC remedies.
•
29 years of sales and marketing experience, including 19 years of national level
management, sales, marketing and new product development in the drug and
nutritional supplement industry.
•
Experienced in the formulation and manufacturing of prescription drugs, OTC drugs
and nutritional supplements in tablet, capsule, powder and liquid form.
•
Served over 48,000 retail locations nationwide.
38
Management Background (cont.)
Arthur Pirrone, Vice President of Sales
•
Over 30 years experience in the sales and marketing of Health & Beauty Aid products.
•
Well known industry expert and respected in the mass market field.
•
Prior experience includes sales, marketing, training and managerial positions with three
Fortune 500 companies, as well as top level management position with several
entrepreneurial OTC/HBC organizations.
•
Extensive experience in launching new products, expanding distribution of currently
stocked brands and maximizing the profitability of each product line. He has hired,
trained and managed both direct and broker/rep national sales forces.
39
Management Background (cont.)
Jim Higgins, COO and CFO
•
Formerly served as an Officer and/or Director of several publicly traded companies.
•
Served as Executive VP of Mitchell Health Marketing Alliance, a sales and marketing
firm with additional expertise in product development, manufacturing, retail
distribution and logistics of OTC drugs and nutritional supplements.
•
Spent 15 years with the AC Nielsen Co., where he was responsible for managing
accounts with some of the most prominent consumer product companies in America,
including Kraft Foods and Unilever’s – Good Humor Breyers Ice Cream.
40
Migraine Market Projections
Factory Sales Projections Based on Market Share
TEN UNITS PER YEAR PER PATIENT
$120,000,000
$108,000,000
$100,000,000
$80,000,000
$54,000,000
$60,000,000
$40,000,000
$27,000,000
$20,000,000
$0
.5% (250,000
patients)
1% (500,000
patients)
2% (1,000,000
patients)
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Investment Summary
New investor summary
•
•
•
•
•
PuraMed BioScience has achieved all of the key milestones it set forth for its launch of LipiGesic
M into the US market as a credible effective treatment for migraine headaches.
The company has developed a migraine treatment that outperforms the number one selling
prescription treatment in the relief of pain and associated symptoms, safety, ease of use, ease of
access(no Rx needed) while cutting treatment costs by at least 75%.
On January 3, 2011 the company announced that it had completed its clinical study on LipiGesic
M. This study was conducted by three nationally recognized headache specialists including Roger
Cady MD, Jerome Goldstein MD and Robert Nett MD RPh.
On June 2, 2011 the company announced that the clinical study proving LipiGesic M as a highly
effective treatment for migraine headaches was published in the top tier medical journal
Headache.
On September 20, 2011 the company announced that it has achieved national distribution with a
top US retailer (Walgreens).
42
Contact Info
PuraMed BioScience, Inc.
Russell Mitchell, Chairman and CEO
715-359-6373
[email protected]
www.puramedbioscience.com
Investor Relations:
Investor Awareness, Inc.
Tony Schor or James Foy, 847-945-2222
Website: www.investorawareness.com
Media:
North Shore Public Relations, Inc.
Renae Placinski, 847-945-4505
[email protected]
Website: www.northshorepr.com
43