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ML141 NEW AND IMPROVED DOCETAXEL INJECTION (TAXOTERE) William Zhao, PhD MBA CEO, Meridian Lab

Meridian Labs 1130 W Lake Cook Rd, Suite 202, Buffalo Grove, IL 60089. ML141 NEW AND IMPROVED DOCETAXEL INJECTION (TAXOTERE) William Zhao, PhD MBA CEO, Meridian Lab. Outline. Introduction/formulation Regulatory strategies Summary Q and A. Introduction. Meridian Lab

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ML141 NEW AND IMPROVED DOCETAXEL INJECTION (TAXOTERE) William Zhao, PhD MBA CEO, Meridian Lab

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  1. Meridian Labs 1130 W Lake Cook Rd, Suite 202, Buffalo Grove, IL 60089 ML141NEW AND IMPROVED DOCETAXEL INJECTION(TAXOTERE)William Zhao, PhD MBACEO, Meridian Lab www.meridian-lab.com

  2. Outline • Introduction/formulation • Regulatory strategies • Summary • Q and A www.meridian-lab.com

  3. Introduction • Meridian Lab • Headquarters: Buffalo Grove, IL • Labs: Nanjing, China • Focus • Commercialize lead candidate ML141 in US and EU • Proprietary PS80-free formulation of Taxotere • Proprietary PS80-free formulation of Cabazitaxel www.meridian-lab.com

  4. Taxotere and Jevtana • Taxotere: Docetaxel with PS80* • Chemotherapy for Breat, lung, prostate, stomach, and head and neck cancer. • Jevtana: Cabazitaxel with PS80* • Chemotherapy for prostate cancer. • Sales • Taxotere sales $3B before patent expired • Jevtana $450MM annual sales * Polysorbate-80 www.meridian-lab.com

  5. Taxotere and Jevtana Unmet needs for improvement • Safety concerns: Hypersensitivity, fluid retention (Black Box Warning) • Contraindicated if history of severe hypersensitivity reactions to API or to drugs formulated with polysorbate 80 • Steroid pretreatment required • Reconstitution required for the two-vial formulation * Polysorbate-80 www.meridian-lab.com

  6. ML141/ML181 Characteristics • PS80-free docetaxel • SBECD/Captisol as solubilizing agent • Liquid formulation • IV, single vial • Global Patent www.meridian-lab.com

  7. Competitive Landscape: Docetaxel Approved generics: all contain S80 • Hospira • Accord Healthcare • Actavis Inc • Sandoz • Teva (ex-US) • Apotex (ex-US) • Mylan (ex-US) • Eagle www.meridian-lab.com

  8. Regulatory Strategy: 505(b)(2) • One of the FDA drug approval pathways • Full safety and efficacy • Allow the information to come from the brand drug • Much less expensive and much fasterroute to approval • Allow improvement/modification to the btand drug • Need to create a bridge to the brand drug www.meridian-lab.com

  9. Regulatory Strategy: 505(b)(2) ML141 regulatory package: • Reference Taxotere for efficacy and safety • Same label as Taxotere without warning/references to PS80 • Demonstrate same PK profile as Taxotere • No clinical efficacy/safety study required for submission Same package for ML181 www.meridian-lab.com

  10. Key Pre-clinical Data • Efficacy • Hypersensitivity • Bioequivalence www.meridian-lab.com

  11. Dose-Dependent Efficacy Similar to Taxotere Tumor Volume (NSCLC in nude mice) www.meridian-lab.com

  12. No Evidence of Hypersensitivity Heart Rate Systolic Blood Pressure Canine Model (docetaxel 1.0 mg/kg) ML061 ML061 TAXOTERE TAXOTERE www.meridian-lab.com

  13. Bioequivalence to Taxotere Pharmacokinetics in Rats www.meridian-lab.com

  14. Captisol/Taxons • Studies demonstrated the safety benefit of removing PS80 with Captisol/SBECD • PK profiles not affected, hence bioequivalent • Rapid regulatory submission/approval pathway www.meridian-lab.com

  15. Summary • Only PS80-free docetaxel/cabazitaxel • Patent (US, EU, Japan and China) • Same efficacy and better safety profile • Rapid regulatory path: 505(b)(2) • Simple manufacturing process www.meridian-lab.com

  16. Other PS80 free formulations (Nano technology) Emulation Lipid Albumin Clinical studies showed different PK. None is actively developing due to required safety/efficacy studies Other PS80 Free Formulations 16 www.meridian-lab.com www.meridian-lab.com

  17. Thank You www.meridian-lab.com

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