In contrast, the Competitor had only one main program under way (the Phase II trial for which the results were just reported), and only in the US. The Competitor has not yet built anything in Europe, and it is typically a multi-year process to do so.
Market Timeline and Access Differences. Since NW Bio is well under way with a Phase III trial now, and the Competitor will need to conduct a Phase III trial, and the Competitor's Phase III trial will need to be quite large if it is powered for results similar to those just announced from the Phase II trial, NW Bio believes it is now potentially at least 3 to 4 years ahead of the Competitor on the clinical development pathway.
NW Bio also has orphan drug status granted in both the US and Europe for DCVax-L for GBM and other glioma brain cancers. The orphan drug laws grant 7 years of market exclusivity in the US and 10 years of market exclusivity in Europe for products that are the first of their type to reach the market. Such market exclusivity could apply to NW Bio's DCVax-L. If so, the scope could be broad: for treatment with DCVax-L, there are no limitations based on either tumor characteristics or patient characteristics. Generally, any GBM patient can be treated with DCVax-L if their immune cells are adequate and just 2-3 grams of their tumor tissue (roughly similar in size to one sugar cube) can be obtained, to provide the antigens for the product.
"At NW Bio we have worked long and hard, and without major fanfare, to develop our technology, our robust clinical trial designs, and our many chances for success through multiple programs on two continents," commented Linda Powers
SOURCE Northwest Biotherapeutics
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