1. 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 W Lake Cook Rd, Suite 202, Buffalo Grove, IL 60089
August 2018

2. Outline Introduction/formulation Regulatory strategies Summary Q and A
WILLIAM
August 2018

3. 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

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
STEVE
August 2018

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
STEVE
August 2018

6. ML141/ML181 Characteristics
PS80-free docetaxel
SBECD/Captisol as solubilizing agent
Liquid formulation
IV, single vial
Global Patent
STEVE
August 2018

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
STEVE
August 2018

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
STEVE
August 2018

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
STEVE
August 2018

10. Key Pre-clinical Data Efficacy Hypersensitivity Bioequivalence STEVE
August 2018

11. Dose-Dependent Efficacy Similar to Taxotere
Tumor Volume (NSCLC in nude mice)
STEVE
August 2018

12. No Evidence of Hypersensitivity
Canine Model (docetaxel 1.0 mg/kg)
Heart Rate Systolic Blood Pressure
ML061
ML061
TAXOTERE
STEVE
TAXOTERE
August 2018

13. Bioequivalence to Taxotere
Pharmacokinetics in Rats
STEVE
August 2018

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
August 2018

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
August 2018

16. 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 16

17. Thank You
August 2018