NW Bio Establishes Cross-Border Manufacturing And Distribution For DCVax® In Europe
Approvals Expanding the Scope of German Manufacturing Are Key Steps
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.
The separate manufacturing authorization for Hospital Exemption cases (Section 4b) has recently been approved as well, by the local regulators and the German Federal regulator (the Paul-Ehrlich-Institut, or PEI – the German equivalent of the U.S. FDA).
The Company is now awaiting a decision from the same German regulator (the PEI) on the Company's Section 4b application itself (the application for approval to treat Hospital Exemption cases) – the cases for which the manufacturing authorization has now already been received. The Section 4b application was submitted to the PEI last fall, following a 5-month Scientific Advice process with the PEI.
"Biotech companies, and especially cell therapy companies, have a tendency to grossly underestimate what it takes to build robust manufacturing and distribution networks," commented Linda F. Powers, CEO of NW Bio. "It requires intensive work years ahead of time, which does not receive much fanfare or 'credit,' but can make or break the success of a Phase III trial program and commercialization. At NW Bio, we have been working intensively for years on building strong manufacturing and distribution arrangements in both the U.S. and Europe, and we are continuing to do so. It is now a major area of competitive differentiation and strength for us."
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program is a 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal brain cancer. The Company also previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I/II trials in multiple other cancers. The Company has also conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Company's ability to raise additional capital, risks related to the Company's ability to enroll patients in its clinical trials and complete the trials on a timely basis, the uncertainty of the clinical trials process, uncertainties about the timely performance of third parties, and whether the Company's products will demonstrate safety and efficacy. Additional information on these and other factors, including Risk Factors, which could affect the Company's results, is included in its Securities and Exchange Commission ("SEC") filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
SOURCE Northwest Biotherapeutics
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