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Northwest
Biotherapeutics, Inc.
t (240) 497-9024
f (240) 627-4121
www.nwbio.com
OTCBB: NWBO
4800 Montgomery Lane
Suite 800
Bethesda, MD 20814
FOR IMMEDIATE RELEASE
Media Contacts:
Les Goldman, 202-371-7700
[email protected]
Heather Ford, 410-598-8256
[email protected]
NWBT HIGHLIGHTS COST EFFECTIVENESS OF DCVAX®
IN VIEW OF RECENT IMMUNOTHERAPY PRICING CONCERNS
Bethesda, Maryland, August 10, 2011 -- Northwest Biotherapeutics (OTC.BB: NWBO) reminded
markets, in response to recent investor concerns about Dendreon’s Provenge immune therapy, that
NWBT’s DCVax® immune therapies for a broad range of cancers (including prostate, brain,
ovarian and others) hold the promise, based on available data to date, of being cost effective and
priced below other immune therapies while still providing substantial profit margins for the
Company and longer survival for patients.
The investor concerns in the news relate to the pricing and reimbursement of Provenge for late
stage, metastatic prostate cancer. Provenge is priced at $93,000 for one month of treatment and
was approved by the FDA based upon having added 4.5 months of patient survival (to reach
overall survival of 25.9 months).
NWBT’s DCVax® will be priced in the range of $37,000 per year for up to 3 years of treatments.
In NWBT’s Phase I/II multi-center clinical trial in late stage, metastatic prostate cancer, DCVax®
added 18 months of patient survival (to reach overall survival of 38.7 months). DCVax® has
previously been cleared by the FDA for a 612-patient, randomized, controlled Phase III trial,
although the trial has not yet begun. As is typical before a Phase III trial, the manufacturing
processes and product costs have already been determined.
Linda Powers, Chairman of the NWBT Board and CEO commented that "It is really important
that pricing and reimbursement concerns associated with certain immune therapies, such as
Provenge, not cause a disillusionment with all of the emerging immune therapies for cancer. Some
of these, such as DCVax®, while at an earlier stage of development, continue to progress and offer
the potential for real cost-effectiveness, easier administration to patients, and longer extensions of
patients’ survival, as well as an absence of toxicity.”
The pricing of DCVax® will also be substantially below the price range of most antibody drugs
and “targeted” drugs for cancer. Such drugs are typically priced at $60,000-80,000 per year, and
can exceed $100,000 per year. Such drugs also carry significant side effects, and often only
extend survival for as little as 10 weeks.
The key to the substantial pricing advantage of DCVax® is NWBT’s proprietary batch
manufacturing process together with its cryopreservation technology for frozen storage of the
finished vaccine. NWBT has spent a decade developing and improving its manufacturing and
cryopreservation processes. The manufacturing of personalized, living cell products is expensive.
But the frozen storage of living cells is quite low-cost – once the specialized freezing technology is
worked out for a particular type of cells (the culture conditions, rate of freezing, density of cells
and many other factors).
NWBT’s manufacturing methods produce – in a single manufacturing run – a large batch of
personalized DCVax® product for 3 years of treatments that are much less costly than separate
manufacturing runs for each treatment. The technology for freezing the master immune cells
(dendritic cells) which comprise DCVax® enables these cells to remain frozen for years and, when
needed, to be thawed and “come back to life” with full potency.
This approach makes DCVax® an "off the shelf” product for several years of treatments after just
one manufacturing run. In contrast, Dendreon must do a separate manufacturing run for each one
month of treatments. In addition, Dendreon's Provenge product is fresh and not cryopreserved,
which limits its shelf life to at most a few weeks.
Another important factor in the cost effectiveness of DCVax® is its simplicity and ease of
administration. DCVax® is delivered as a small intra-dermal injection under the skin, similar to a
flu shot. As such, it can be administered in any physician’s office or clinic. There is no lengthy
intravenous infusion, with the attendant patient discomfort, cost and need for a specialty infusion
center. In contrast, Dendreon’s Provenge is delivered by intravenous infusion.
The cost effectiveness of NWBT’s DCVax® is enhanced by the fact that DCVax® is targeting
a portion of the prostate cancer market that is 4 times the size of the market segment that
Dendreon’s Provenge is currently targeting. The late stage prostate cancer market breaks down
into two groups of patients: those who do not yet have metastases (i.e., spread of the cancer
beyond the prostate), who constitute 80-85% of the market, and those who do already have
metastases, who constitute 15-20% of the market. Dendreon’s Provenge is approved for and
targeted to the patients with metastases (i.e., the 15-20% portion of the market). In contrast,
NWBT’s prior Phase I/II trial treated both groups of patients, and NWBT’s 612-patient Phase III
trial design is focused on the much bigger market: patients without metastases (i.e., 80-85% of the
market).
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. The Company has a broad platform
technology for dendritic cell-based vaccines. The Company’s lead clinical trial, with a growing
number of sites, is a 240-patient, Phase II trial in newly diagnosed Glioblastoma multiforme
(“GBM”), the most aggressive and lethal form of 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 trials in five other cancers. The Company has also conducted a Phase
I/II trial with DCVax® for recurrent metastatic ovarian cancer. For further information about
clinical sites and/or about the Company, please visit the Company’s web site at www.nwbio.com.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning
future treatment of patients with GBM using DCVax®-Brain and future clinical trials, are forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Words such as “expects,” “believes,” “intends,” 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 forwardlooking 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.