Conference date: September 24, 2009 @ 5:45 AM Pacific Time
Introduction by Mitchell Grove. Currently median survival for men with the type of prostate cancer Provenge is in trials for is 20 months. There is only one approved treatment, docetaxel, is toxic. The Dendreon team is devoted to finding better therapies for cancer patients. "Patients First" is their slogan. Submission for Provenge to FDA should be in mid-November, with result date from FDA in the middle of 2010. Preparing to scale up manufacturing of of Provenge in anticipation of approval.
Provenge is the beginning of a whole line of products.
Charles Drake spoke on the clinical immunotherapies. One in six men get prostate cancer in their life times. 30,000 men each year die from prostate cancer in the United States. Most men are diagnosed with localized disease. This can progress to biochemical recurence and get chemical castration. But some men progress to Castration resistant disease, and get secondary hormone therapy. Those who progress are metastastic hormone castrate-resistant. Docetaxel provides proven benefit but is toxic.
Active Cellular Immonotherapy (ACI) uses active Cd8 killer T cells, which can lyse chemotherapy-resistant cells. There are a variety of ways to activate CD8 T cells. Several approaches have been tried for to use CD8 T cells for cancer. GVAX approach whole cell approach failed. ProstVac VF virus approach Phase II trial showed survival advantage; Bavarian Nordic is planning a Phase III trial.
For Provenge active cellular immunotherapy with sipuleucel-T patient white blood cells are harvested. SM-CSF with Prostatic acid Phosphatase (PAP) infused cells are they infused back into the patient. You need several rounds to prime and induce the immune reaction. Dr. Drake believes the best results will come from giving Provenge earlier in the cancer progression process (which is forward looking; tested and seeking approval for latest stage of disease)
Two castrate resistant metastatic disease groups, asymptomatic and symptomatic. Believes immunotherapy would be appropriate for asymptomtic group.
Believes Renal Cell cancer and Bladder cancer are believed to be good cancer candidates for immunotherapy. Androgen-ablation may work well with immunotherapy. Could also be combined with checkpoint blockades like anti-CTLA-4.
Mark Frohlich, Chief Medical Officer. Median survial benefit was 3.9 months (total 25.8 months), with significant long term survivors at 33% at 3 years. Did not show significant change in time to disease progression. Cumulative evidence of multiple trials showed consistent benefits and a highly favorable benefit to risk profile.
New, draft FDA guidance document for therapeutic cancer vaccines noted that "subjects may experience disease progression prior to the onset of biological activities or effects from the vaccine." Which addresses the delayed response from Provenge. P11 trial showed evidence of activity earlier after treatment. Other trials continue to examine this issue. FDA is allowing survivors of placebo arm of IMPACT trial to be in OpenACT trial so they can get therapy.
David Urdal, Chief Scientific Officer. "Provenge is going to be a drug that will change men's lives." Talked about manufacturing and logistics issues. Each dose of Provenge is custom made for each patient from their own cells. The New Jersey facility should be capable of producing revenues between $0.5 and $1.0 billion. Los Angeles and Atlanta facilities are being planned.
Pipeline of products and possibility of extension to other cancers was discussed. Based on proven ability to manufacture and administer ACIs, and evaluateactivation. PA2024 Antigen Delivery Cassette is the only know antigen to prove efficatious in clinical trials. CD54 upregulation is measurable, and is done for each lot of Provenge. In addition T-cells, NK cells and other types in the culture can be observed to be activated in the second and third rounds. Explained why sipuleucel-T appears to work when other immunotherapies have failed: the targeted approach, more cells used, and processing outside of patient's immunosuppresive environment.
Neuvenge (lapuleucel-T) for ovarian and breast cancer targets Her2-Neu. Evidence of anti-cancer activity in 22% of patients with prolonged disease stabilization. Could be effective in bladder cancer as well. This program will be restarted in 2010. Also CA9 for Renal Cell Carcinoma and cervical cancer. Expects to put one new product into trials each year going forward.
Revenue ramp will be stepwise. We will be able to bring capacity online very quickly after FDA approval. With midyear launch we would expect a half-year's revenue with 25% of capacity in New Jersey. Beyond 2011 we will have full capacity online to generate $1.2 to $2.5 billion. We will use about $150 million in cash this year. Headcount is now 290 and should about double by time of launch. Expect to have about $200 million cash balance at the end of 2009. Our facilities are actually inexpensive compared to other biologics, but there will be signifcant cost of goods sold, about 30% to start and 20% long-term. Transportation logistics will be expensive.
Reimbursements? We have had discussions with payers. The main payer would be Medicare. It should be no different than other oncology biologics.
EU partnerships? Our plans have not changed. We are seeking an international partner for this product. They will take it through the regulatory process outside the U.S.
Where will you get the 10% margin improvement you spoke of? Price breaks at volume, labor efficiency, amortization spread out over increased revenue.
Transportation? Next flight available on commercial airlines. We have a special package to control temperature during transportation.
We will need some more cash when we begin to commercialize the process. It may be a stock offering, or it could be non-dilutive.
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