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LIAS Proud to Market ITL Pharma Products

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Presentation on theme: "LIAS Proud to Market ITL Pharma Products"— Presentation transcript:

1 LIAS Proud to Market ITL Pharma Products

2 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

3 ITL # Product Name Indication ThyroMaxTM Primary Hypothyroidism PolyPhetamineTM ADHD SuperGlutamineTM Nutritional Gln Source ParkinolTM Parkinson’s Disease Poly-DTM AzololTM Alzheimer’s Disease PolythyroidTM Poly-DA Blu-TTM Diagnostic for Ductal Carcinoma CarcininTM Antineoplastic Blu-T Diagnostic for Systemic Infection Taric 1 Pim 2 SafeSerum® Synthetic Serum Replacement CardioSafe Heart Reperfusion Protectant Poly Glu Formulation Excipient

4 Current Thyroid Products
ThyroMax® trademark-T3 drug candidate BCT303 completed Phase 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

5 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

6 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






12 The Hypothyroid Market
10 million patients in U.S. taking 1 Tab/day = 3.65 Billion Tabs per year Annual Sales $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 $1.00/tab = $ 29 Billion 10% mkt share=$ 2.9 Billion in global sales annually ThyroMax® BCT303

13 We need a better solution.
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

14 The Better Solution ThyroMax® All Hypothyroid patients can be managed
Single Day Dosing means better compliance Better Manageability of Patients Symptoms Stability issues eliminated Reduction of Recalls

15 Time & Events ThyroMax® BCT303 April 2012 August 2012
FDA approved IND, began Phase-I clinical trials August 2012 Completed Phase-I clinical trials August 2014 Completed Phase-II/III clinical trials 1Q 2015 Submit NDA for market approval 1Q 2016 Market Launch ThyroMax® BCT303

16 What Makes This Business Opportunity Unique?
ThyroMax® 1st Single Dose-a-Day Later Stage Development Market Scale Manufacturing Numerous off-label uses Faster to Market 505 (b)(2) Improved Product Stability ThyroMax® BCT303

17 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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