BETHESDA, Md., Aug. 10, 2011 /PRNewswire/ -- 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.
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 forward-looking 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 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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