Brilacidin

Active substance
Brilacidin
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Head and neck cancer
Extended indication
Mucositis in head and neck cancer

1. Product

Manufacturer
Innovation
Mechanism of action
Antibiotic
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)
Additional comments
First-in-class a synthetic, small-molecule defensin-mimetic, for treatment of bacterial infections.

2. Registration

Registration route
Centralised (EMA)
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Scrip pipeline watch 8 jan 2018: Delayed onset of severe oral symptoms. Updated Phase III Results.

3. Therapeutic value

Current treatment options
Momenteel geen behandeling
Therapeutic value
No judgement yet
Substantiation
Beperkte informatie beschikbaar
Duration of treatment
Not found
Frequency of administration
3 times a day
Dosage per administration
3mg/ml
References
NCT02324335
Additional comments
De studie NCT02324335 heeft een behandelduur van 7 weken.

4. Expected patient volume per year

Patient volume

1,500 - 1,900

Market share is generally not included unless otherwise stated.

References
NKR; Oncoline
Additional comments
In 2015 werden 1.899 patiënten met hoofd- en halstumoren behandeld met radiotherapie. Bij 80-100% van deze patiënten treedt mucositis op als bijwerking van deze behandeling, dit bedraagt dus 1.519-1.899 patiënten.

5. Expected cost per patient per year

Cost
4,500 - 9,000
References
http://www.ipharminc.com/new-blog/2019/4/9/brilacidin-competitive-positioning-market-opportunity-for-oral-mucositis
Additional comments
De fabrikant verwacht $5.000 tot $10.000 te kunnen vragen per behandeling. Omgerekend is dit ongeveer €4.500 tot €9.000

6. Potential total cost per year

Total cost

11,475,000

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Skin Infection (Bacterial Infection)
References
Clinicaltrials.gov

9. Other information

There is currently no futher information available.