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).