Power Point Presentation

Report
LIAS Proud to Market
ITL Pharma Products
ITL New Product Pipeline
• Thyroid Hormone Replacement
• Neurodegenerative Diseases
Parkinson’s Disease
Alzheimer’s Disease
• Anti-inflammatories
• Cancer Diagnostics
• Cancer Therapies
• Inflammation Diagnostics
• Production Technologies
• Formulation and Tableting
ITL #
Product Name
Indication
1. 1834
ThyroMaxTM
Primary Hypothyroidism
2. 2034
PolyPhetamineTM
ADHD
3. 1204
SuperGlutamineTM
Nutritional Gln Source
4. 1634
ParkinolTM
Parkinson’s Disease
5. 1610
Poly-DTM
Parkinson’s Disease
6. 1726
AzololTM
Alzheimer’s Disease
7. 1836
PolythyroidTM
Primary Hypothyroidism
8. 1635
Poly-DA
Parkinson’s Disease
9. 4010
Blu-TTM
Diagnostic for Ductal Carcinoma
10. 4016
CarcininTM
Antineoplastic
11. 4017
Blu-T
Diagnostic for Systemic Infection
12. 2035
Taric 1
ADHD
13. 2037
Pim 2
ADHD
14. 1206
SafeSerum®
Synthetic Serum Replacement
15. 4018
CardioSafe
Heart Reperfusion Protectant
16. 825
Poly Glu
Formulation Excipient
Current Thyroid Products
– ThyroMax® trademark-T3 drug candidate BCT303
completed Phase-2 + 3 clinical trials
– Pending patent for platform technology
– T4 drug candidate BCT304, ready for IND submission
– Reverse T3 drug candidate BCT307, ready for IND
submission
– Veterinary use, Evergreen Products
– Additional 505(b)(2) applications already identified,
including pain-relief, anti-abuse products
ThyroMax®
BCT303
ThyroMax® (BCT303)
• The First Advance in Thyroid Replacement
Therapy in More Than 50 Years
• Lead T3 drug candidate to treat
hypothyroidism
• Through clinical trials
• 505(b)(2) drug
• Utilizes platform technology for sustained
effects and improved stability (pending
patent)
ThyroMax®
BCT303
Hypothyroidism
• A condition in which the
thyroid gland does not
make enough thyroid
hormone.
• Symptoms can be
fatigue, depression and
weight gain.
• Most patients must take
thyroid hormone
replacement for the rest
of their lives.
Thyroid Gland
ThyroMax®
BCT303
TARGET
TISSUES
The Hypothyroid Market
• 10 million patients in U.S. taking 1
Tab/day = 3.65 Billion Tabs per year
• Annual Sales Potential @ $2/tab =
$ 7.3 Billion
• 10% mkt share = $730 Million/year
(COG = 6%)
• 80 million patients worldwide at 1
Tab/day=29 Billion tabs per year@
$1.00/tab = $ 29 Billion
• 10% mkt share=$ 2.9 Billion in
global sales annually
ThyroMax®
BCT303
Current Therapies
Therapy
Pro
Con
Synthroid® – T4
Long half-life
in the blood
Not the active form of the drug (T3)
Known lung cancer risk
Cytomel® – T3
The active
form of the
hormone
Can require multiple doses a day;
can release active ingredient too
quickly causing side effects;
stability issues
Armour® Thyroid – T3/T4
Long clinical
history
Dosing not dependable
Known Heart Arrhythmia Risk
We need a better solution.
ThyroMax®
BCT303
The Better Solution
All
Hypothyroid
patients can
be managed
ThyroMax®
Stability issues
eliminated
Single Day
Dosing means
better
compliance
Better
Manageability
of Patients
Symptoms
Reduction of
Recalls
Time & Events
April 2012
FDA
approved
IND, began
Phase-I
clinical
trials
ThyroMax®
August 2012
August 2014
Completed
1Q 2015
Phase-I
Completed
clinical
Phase-II/III Submit
trials
clinical
NDA for
trials
market
approval
1Q 2016
Market
Launch
BCT303
What Makes This Business Opportunity Unique?
1st Single
Dose-a-Day
Improved
Product
Stability
Later Stage
Development
ThyroMax®
Faster to
Market
505 (b)(2)
ThyroMax®
Market Scale
Manufacturing
Numerous
off-label uses
BCT303
Business Strategies
Sale of Drug(s) and/or Technology
Co-Development Agreement
Out-Licensing
Commercialize Internally and/or IPO
ThyroMax®
BCT303

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