BETHESDA, Md., March 12, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax ® personalized immune therapies for solid tumor cancers, announced today that the Company has taken a key step in building Europe-wide arrangements for manufacturing and distribution of DCVax. This represents a major area of competitive differentiation and strength for NW Bio.
The Company and its partners have completed a 7-month process of obtaining the necessary regulatory and institutional approvals in both Germany and the U.K. to expand the scope of the manufacturing in Germany of the Company's DCVax-L product for brain cancer. The scope is being expanded in two major ways: in its geographical reach, and in the product categories covered.
Geographically, these approvals for expanded scope of German manufacturing will enable DCVax-L to be produced in Germany and supplied across borders to the U.K. for the clinical trials. Getting this important cross-border arrangement in place is a key step towards building a Europe-wide distribution network for DCVax products. Although Europe has a common market, the manufacturing and supply of medical products (and especially products composed of living cells such as immune cells) across borders must meet detailed regulatory and institutional requirements in all countries involved.This approval for cross-border supply of DCVax-L is in addition to the manufacturing capacity in the U.K. already developed by the Company with its partner, Kings College London. Such cross-border supply and distribution will provide valuable flexibility to draw upon manufacturing capacity in either the U.K. or Germany as needed. It will also enable economies of scale for serving all of Europe. In regard to the product categories, these approvals will enable DCVax-L to be produced in Germany not only for the Phase III clinical trial, but also for Hospital Exemption cases under Section 4b of the German Drug law (similar to compassionate use in the U.S.) Separate regulatory applications and authorizations are required, at both the Federal and local levels, for the manufacture of products for Hospital Exemption (Section 4b) versus for clinical trials. The Company and its partner, Fraunhofer IZI, already received the manufacturing authorization for the Phase III clinical trial last summer, as the culmination of a 1-1/2 year process of technology transfer, regulatory applications, regulatory review and inspections.