The market and profit for ARG201 is driven by the following factors:
Patient acceptance will be high.
- There is no treatment for the cause of SSc so the patient acceptance of ARG201 should be high.
- dcSSc is a fatal disease which will increase the acceptance of ARG201.
- ROT1 allows the physician to determine which patients will respond and thereby target the appropriate patients. This is generally known as "personalized medicine".
Marketing costs will be lower than for most drugs.
- There are a miniminal number of medical centers that treat most of the US and EU SSc patients. This enables the pharmaceutical company to build awareness of the treatment at an economical cost.
- There are patient support groups in most areas with a significant number of SSc patients which will facilitate the education of the patients with dcSSc.
- The patient are treated by Rheumatologists which will simplify the education of physicians who treat the patients.
ARG201 will have a significant time on market without a direct competitor.
- As an orphan drug and a biologic, ARG201 will receive a 10 year market exclusive period in the EU and a 12 year period in the US which provides a significant opportunity for market development.
The cost to produce ARG201 will be less than the typical drug.
- The purification process is relatively straightforward and comparatively economical when compared to most biologics.
- The volume of ARG201 required to treat the target patients is relatively small - a single syringe will hold enough processed CI to treat one patient a year.
The clinical trials will be comparatively inexpensive.
- As an Orphan Drug the size of each clinical trial will be small compared to a widely used drug.
- Due to the lack of treatments for the cause of the disease, we expect the retention rate for trial participants to be high.
The Company has estimated the addressable dcSSc market:
- The initial target population of patients eligible for the treatment is estimated to be approximately 50,000, in the US and EU.
- Comparable drugs addressing serious diseases but with lesser morbidity and mortality are currently being marketed for between $60,000 and $120,000 per year.
- The addressable market penetration is estimated to be 50% and at orphan drug pricing, the revenue potential for ARG201 is approximately $1.6 Billion.
AutoImmune Disease Treatments