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Drug Re-Formulation - Creating New Business Opportunities

Drug Re-Formulation - Creating New Business Opportunities. Dr. Alex Nivorozhkin, Chief Operating Officer Amorsa Therapeutics Inc., USA Pharmaceutics & Novel Drug Delivery Systems, March 16-18, 2015, Dubai. www.amorsatx.com.

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Drug Re-Formulation - Creating New Business Opportunities

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  1. Drug Re-Formulation - Creating New Business Opportunities Dr. Alex Nivorozhkin, Chief Operating Officer Amorsa Therapeutics Inc., USA Pharmaceutics & Novel Drug Delivery Systems, March 16-18, 2015, Dubai www.amorsatx.com

  2. The Need in Pain ManagementA Potent Non-Opioid Without the Adverse Effects Morphine has been the gold standard for treating moderate-to-severe pain for nearly 200 years! It’s time for a change: • 16,000 deaths per year due to opioid overdoses • High potential for addiction • Disabling side effects • Tolerance development 2

  3. Why Reformulate Existing Drugs? • Extending life cycle of the product (IP issues) – salt formation, route of administration, proprietary delivery • Improve patient compliance, frequency, ease of administration -depot formulations (CNS) • Serve newly found therapeutics indications -adjusting dose, route of administration, delivery • Improving poor intrinsic physico-chemical properties • Poor bioavailability (due to poor solubility and/or permeability) • TCI reports (2014) identified 30 recently launched drugs with poor bioavailability • BCS Class IV oral drugs sales >$145 B 3

  4. How to Find and Validate a Good Idea? Multistep Iterative Process, You’ll have to Adapt • Talk to the DOCTORS - Unmet medical needs - Capitalize on something already used off-label - Incorporate new formulation into existing practices • Make friends with IP LAWYERS - IP landscape complicated due to years of disclosures and patent activity - Formulation patents are almost always perceived “weaker” than composition of matter (new API) • Set an alliance with PHARMACOLOGISTS • The interest jumps if you have in vivo data • Understanding animal models (efficacy) • Understanding toxicology aspects • Introduce your idea to a BUSINESS PERSON • First pass on commercial potential • Interactions with potential investors 4

  5. Unmet Medical Need for Pain Management U.S. Market for Opioid Analgesics - $8.3 Billion (2013) 5

  6. Unlocking Ketamine’s Potential “The medical community is missing out on one of the best pain drugs there is.”Director, Defense Center for Integrative Pain Management • Ketamine was approved as an anesthetic in 1970 • Recent studies have shown ketamine’s analgesic and antidepressant effects but with undesirable side effects • Majority of therapeutic benefits are due to the conversion of ketamine to norketamine • Amorsa is developing proprietary formulations of novel ketamine analogs designed to: • Deliver the potency of ketamine with fewer adverse effects • Be administered as convenient oral formulations • Offer patients an effective alternative to opioids 6

  7. Ketamine Pharmacology Challenge Human PK Data (3rd party results) • Problems • Spikes in plasma concentration leading to psychomimetic side effects • Short exposure due to fast clearance Target Efficacy & Safety Range • Amorsa Solutions • Steady, controlled release formulations designed to limit spikes and improve kinetics • Focus on Norketamine – an active metabolite of KTM-with 2.5x half-life • Selectively deuterated nor-KTM analogs further extend exposure by 50 % (overall ca. 4x vs. KTM) Oral ketamine solution in healthy volunteers 7

  8. Leadership Team & Business Advisors 8

  9. Scientific & Clinical Advisory Board 9

  10. Amorsa’s Drug Development Platform 10

  11. Formulation Effects on Drug Release Novel hydrogel formulations of ketamine showing varying release profiles (in vitro experiments) Steady release of therapeutically effective concentrations without toxic spikes In vitro data translates well into in vivo dog model Technology applies to ketamine, norketamine and derivatives including (S)-norketamine-d Prototypical tablets formulated with racemic ketamine 11

  12. Pilot PK Dog Study Using Ketamine-ER24 Tablet Formulation Confirms a strong in vitro/in vivo correlation Target Efficacy & Safety Range Obtained target plasma drug levels for 24 hours without concentration peaks Validates our pathway for rapid optimization of future formulations 20 mg ketamine tablets 12

  13. Deuterated (S)-Norketamine Analogs (S)-Norketamine • Previously studied compound with well-characterized pharmacological activity • Norketamine, the active metabolite of ketamine • More attractive PK profile than ketamine • S isomer has more potency than R S-Norketamine Deuterium Modification • Targeted modifications to create novel drug candidates • Provides improved pharmacokinetic properties that enhance safety and efficacy (S)-Norketamine-d 13

  14. Preclinical Product Candidates Developing both fast acting and extended release formulations 14

  15. 3-Year Drug Development Plan Note: Plan does not assume Fast Track designation or modified 505(b)2 path – both are possible pending FDA review 15

  16. Who Dares, Wins

  17. Contacts: Alex Nivorozhkin, Ph.D. Chief Operating Officer (617) 921-0114 aniv@amorsatx.com www.amorsatx.com 17

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