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  • PIPELINE
  • Biobetter IMD

PIPELINE

Diversified pharmaceutical company with divisions
for novel medicines and complex generics

Biobetter IMD Pipeline Strategy

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Enbrel biobetter

Enbrel (Etanercept)
Indication Rheumatoid Arthritis, Psoriasis, etc.
Global market $7.1B (Amgen & Pfizer annual report 2018)
Biosimilar plant Celltrion, Samsung Bioepis, etc.
CurrentDosage 25 mg twice a week or 50 mg SC once weekly
Target Dosage Once in 1 -2months
Current development stage formulation, in vitro study completed.
Future plan in vivo PK study in diseased model, nonclinical tox study, etc.
Development strategy Collaboration with biosimilar companies and license-out.

Testing Protocol: 100㎕ diluent added to formulation and resulting solution exposed
to physiological conditions. At each time point, formulations were centrifuged
and supernatant removed for HPLC analysis Result: ~60% drug release was observed up to 56 days Confirmed sustained releasefor 2 months

Ropivacaine sustained release IV injection

Ropivacaine
Current T1/2 4-6 hours
Target T1/2 72 hours
Solutions to UnmetNeeds Reducing pain after surgery, less narcotic analgesic use, Quick recovery
Development stage formulation development (suspension, ready to use, single use vial that delivers dose of 500mg (50mg/mL, 10mL), in vitro study completed)
Development plan in vivo study (PK study in animal model), Tox study, etc.
Development strategy Discuss Asia licensing rights at non-clinical stage and US, EU licensing rights at clinical stage.

Formulations containing 10mg Ropivacaine was formulated using BAIT® NPT 100㎕ diluent added to each formulation and resulting solution exposed to physiological conditions At each time points. formulations were centrifuged and supernatant removed for HPLC analysis, and replenished with new mL PVA. Result: Confirmed sustained release for 96 hours