Commercialization: Immediate Short-Term, Vast Long-Term Potential
Vaccinogen’s OncoVAX® vaccine offers outstanding potential for commercial success, both in the short term and long term. Its approval for commercial use in Switzerland will likely yield near term revenues in Switzerland & Germany 1H 2010. A vast global market could unfold as soon as 2013 as discussions have been established with six other potential distribution partners to sell OncoVAX® in Scandinavia, the Middle East, South America and Asia.
Potential Commuter Patients
Over this initial three-year period prior to initial ramp up commercial launch in the US and Western Europe, projected revenues are based on existing distribution agreements that
cover Germany, Switzerland and Eastern Europe.
The countries contiguous to Switzerland are as follows:
| Country | # of Stage II Cases/Year |
| Italy | 12,000 |
| Germany | 15,000 |
| France | 8,600 |
| Austria | 1,200 |
| Total | 36,800 |
* France, Germany, Austria and Italy have potential patients who may seek treatment in Switzerland or the Eastern European countries as self-pay patients.
**Potential market based on EMA Conditional Marketing Authorization 2010
Vaccinogen has met many of the challenges of commercialization
- Created an automated identity, potency & product characterization for a patient-specific tumor vaccine.
- Developed a patented sterile manufacturing process for patient-specific tumor vaccines, with the participation of the surgeon and the pathologist in the operating room.
- Received regulatory approval of a commercial manufacturing facility in Holland by Dutch/Swiss Authorities.
- Opened a 900/m² (9600 ft²) facility that has five class B manufacturing suites and two class C QC laboratories with a capacity to produce 3,500 OncoVAX® vaccines per year ($130M/£65M) – a production amount sufficient to cover the pivotal Phase IIIb clinical trial and the commercial sales of OncoVAX® in Germany, Switzerland and Eastern Europe.