12
MAR
2013

NW Bio Establishes Cross-Border Manufacturing And Distribution For DCVax® In Europe

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Approvals Expanding the Scope of German Manufacturing Are Key Steps

BETHESDA, Md., March 12, 2013 – 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. 

Disclaimer

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.

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