Winstgevend schreef op 4 december 2018 14:50:
Pharming Group N.V. - Personal view.
New Indications estimated timeframe Q1-2019/Q3-2023
Based on two indications in development:
Pre-Enclampsia and Contrast Induced Nephropathy,
having a combined market potential of
$8.1 billionOverview using most recent statistical data over 2017 and 2018
Top-3 Indications under development:HAE - 6.000 patients- 305 known patients using Ruconest for acute treatment
- Ruconest-acute estimated 2018 total revenues:
€130 million- Ruconest-acute market potential approximately
$900 millionPre-Enclampsia - 463.200 US-ONLY cases in 2017 - 0 using Ruconest
- no approved medications availiable.
- US had 3.86 million births in 2017
- 10% to 11% pregnancies developed Mild preenclampsia
- 1% to 2% pregnancies developed Severe preenclampsia
- Total market potential approximately
$2.6 billion - (based on minimal pricing of $5647.38 per vial Ruconest)
- (
www.wellrx.com/prescriptions/ruconest )
Contrast Induced Nephropathy - 1.000.000 patients per year - 0 using Ruconest
- no approved medications availiable.
- Phase II trial gave excellent results and were above expectations
- Total market potential approximately
$5.5 billion - (based on minimal pricing of $5647.38 per vial Ruconest)
- (
www.wellrx.com/prescriptions/ruconest )
Completed and expected clinical trials and approvaldates(based on three clinical trials per indication without priority)
Pre-Enclapsia:
- Start of Phase II Clinical trial in
Q1 2019- Providing clinical results of preenclampsia show positive results.
- Start of Phase III Clinical trial in Q3 2020
- Request for FDA-Approval in Q1 2022
- Possible DFA-Approval in Q1 2023
- Marketing startup by Q3 2023
Contrast Induced Nephropathy:
- Completed Phase II Clinical trial in Q4 2018 (positive results)
- Start of Phase III Clinical trial in
Q1 2019 - Request for FDA-Approval in Q4 2020
- Possible DFA-Approval in Q4 2021
- Marketing startup by Q2 2022
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