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 6. 1726 AzololTM Alzheimer’s Disease 7. 1836 PolythyroidTM 8. 1635 Poly-DA 9. 4010 Blu-TTM Diagnostic for Ductal Carcinoma 10. 4016 CarcininTM Antineoplastic 11. 4017 Blu-T Diagnostic for Systemic Infection 12. 2035 Taric 1 13. 2037 Pim 2 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
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
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
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
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
Business Strategies Sale of Drug(s) and/or Technology Co-Development Agreement Out-Licensing Commercialize Internally and/or IPO ThyroMax® BCT303