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 WILLIAM Meridian Labs 1130 W Lake Cook Rd, Suite 202, Buffalo Grove, IL 60089 August 2018 www.meridian-lab.com
Outline Introduction/formulation Regulatory strategies Summary Q and A WILLIAM August 2018 www.meridian-lab.com
Introduction Focus 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 WILLIAM I don’t think the last two bullets are necessary. It tells them who we are and what we are about! The change made to bullet #3 above adds detail to the focus. I don’t think knowing the amount of money spent so far is a good opening. I think they are more interested in what has been achieved. But if you want the last two bullets, I’ve included them below. Clinical/regulatory strategy: cost effective and time efficient US and EU approval of ML061 Costs: $6 million spent in R&D since 2006 August 2018 www.meridian-lab.com
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 STEVE August 2018 www.meridian-lab.com
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 STEVE August 2018 www.meridian-lab.com
ML141/ML181 Characteristics PS80-free docetaxel SBECD/Captisol as solubilizing agent Liquid formulation IV, single vial Global Patent STEVE August 2018 www.meridian-lab.com
Competitive Landscape: Docetaxel Approved generics: all contain S80 Hospira Accord Healthcare Actavis Inc Sandoz Teva (ex-US) Apotex (ex-US) Mylan (ex-US) Eagle STEVE August 2018 www.meridian-lab.com
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 STEVE August 2018 www.meridian-lab.com
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 STEVE August 2018 www.meridian-lab.com
Key Pre-clinical Data Efficacy Hypersensitivity Bioequivalence STEVE August 2018 www.meridian-lab.com
Dose-Dependent Efficacy Similar to Taxotere Tumor Volume (NSCLC in nude mice) STEVE August 2018 www.meridian-lab.com
No Evidence of Hypersensitivity Canine Model (docetaxel 1.0 mg/kg) Heart Rate Systolic Blood Pressure ML061 ML061 TAXOTERE STEVE TAXOTERE August 2018 www.meridian-lab.com
Bioequivalence to Taxotere Pharmacokinetics in Rats STEVE August 2018 www.meridian-lab.com
Captisol/Taxons Studies demonstrated the safety benefit of removing PS80 with Captisol/SBECD PK profiles not affected, hence bioequivalent Rapid regulatory submission/approval pathway August 2018 www.meridian-lab.com
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 August 2018 www.meridian-lab.com
Other PS80 Free Formulations Other PS80 free formulations (Nano technology) Emulation Lipid Albumin Clinical studies showed different PK. None is actively developing due to required safety/efficacy studies August 2018 www.meridian-lab.com www.meridian-lab.com 16
Thank You August 2018 www.meridian-lab.com