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. If an approval for use on a named patient basis is granted in Germany, revenues may be recognized as soon as 2011. A vast global market could unfold by 2015 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 four-year period prior to initial ramp up to commercial launch in the US and Western Europe, projected revenues are based on potential approvals for distribution on a named patient basis in Germany and Europe.
The countries contiguous to Germany are as follows:
| Country | # of Stage II Cases/Year* |
| Italy | 12,000 |
| Germany | 15,000 |
| France | 8,600 |
| Austria | 1,200 |
| Total | 36,800 |
*Estimated
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* France, Austria and Italy are likely to follow Germany
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 initial European sales, as authorizations permit.
- Was given a declaration from the European Medicines Agency (EMA) that "OncoVAX® falls within the classification of Advanced Therapeutic Medicinal Product (ATMP) for somatic cell therapy as provided in Article 2(1)(a) of Regulation (EC) No 1394/200." Only three products have achieved this classification.