|Better, broader, less expensive are parts of the message Dendreon forgot|
|By Staff and Wire Reports|
|Wednesday, 10 August 2011 09:37|
In response to recent market concerns about Dendreon’s (Nasdaq:DNDN) recent price plunge, today Northwest Biotherapeutics (OTCBB:NWBO) reminded investors that their own immune therapies for prostate, brain, ovarian and other cancers hold the promise of being cost effective and priced below others.
Based on available data to date, officials at the company feel their platform will be priced well below other immune therapies and could still provide substantial profit margins and longer survival for patients. Recent headlines caused DNDN's share prices to drop considerably after investors worried about the pricing and reimbursement concerns about Provenge for late stage, metastatic prostate cancer.
Northwest Biotherapeutics officials say Provenge is priced at $93,000 for one month of treatment versus their own DCVax® which will be priced in the range of $37,000 per year for up to 3 years of treatments.
In NWBO'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.
Dendreon's therapy was approved by the FDA based upon having added 4.5 months of patient survival (to reach overall survival of 25.9 months).
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).
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).
Northwest Biotherapeutics is 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. NWBO has a broad platform technology for dendritic cell-based vaccines.
Currently NWBO’s lead clinical trial 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.