All fifteen Medicare regions and 80% of private payers have now approved Provenge (sipuleucel-T) for (asymptomatic or minimally symptomatic metastatic hormone refractory) prostate cancer for reimbursement. Expects to increase capacity by a factor of ten in 2011; should have 450 infuser sights by the end of the year; already hired 100 sales people.
$48 million total Provenge revenue in 2010, with about $25 million in Q4. $350 to $400 million revenue expected in full 2011, with about half of that coming in Q4. $280 million cash balance at the end of the year. GAAP loss of $310 million to $350 million for 2011; non-gAAP loss of $230 to $270 million.
Europe will be the first target for further Provenge approval. Believes addressable market would be about the same size as in the United States. There is a major unmet medical need there. After meeting with the European regulatory agency (EMA), IMPACT and other data already available should be sufficient to get European regulatory approval. Will engage a contact manufacturing organization for initial Provenge supply in Europe. Will also use this for trials for earlier-stage prostate cancer. But will concurrently build a Dendreon facility in Germany in 2011.
EMA decision would be possible in 2013. Reimbursement must be achieved nation by nation, and there are challenges. But as overall survival is the gold standard for European payers, and overall costs are actually reasonable for Provenge. Cancer therapy prices are largely similar in Europe to the U.S.
$125 million will be spent in 2011 to support American and European expansion, with about half attributed to capital expense and half to operating expense. Will require more capital for the European expansion.
ACI (autologous cellular immunotherapy) platform now includes an investigational product Nuvenge (DN24-02) for invasive bladder cancer. This is a highly immuno-responsive. Will be a randomized Phase II study for patients with HER2+ invasive transitional cell carcinoma of the bladder following cystectomy. Patients with advanced cancer have few good treatment options at present. Endpoint would be overall survival.
Plans are for one plant in Europe? It is not necessarily our expectation that we would only ever have one. If reimbursements are approved, we could build more plants.
The European, or global, study would not be to support the regulatory filing. It would be to provide evidence of the efficacy of Provenge for earlier stages of prostate cancer.
Trajectory for expanding infusion centers? Started with 50, finished with slightly more. 450 should be available in Q4. The launch centers had been in previous clinical trials, many in very small clinics. Some of the new centers are much larger in terms of numbers of patients. First additional capacity should come on line in New Jersey, corresponding to about a third of the new centers also starting up.
Europe, maximum capacity for German facility? Seen as very similar to the Los Angeles and Atlanta facilities in design and capacity. Because population density is higher, the center could serve all of the EU countries.
The Contract Manufacturing Facility in Europe would support the new study there. The new Dendreon facility should be ready around the time of approval.
Any message change on prostate cancer since Provenge approval? We are in a golden era now for prostate cancer. Good data sets are coming out for drugs for the chemo-sensative prostate cancers.
Still 2000 patients for 2010? That was for middle of the year, which would be in July 2011.
New Jersey expansion should come online some time in March, but new clinics are already ready to go when that capacity does come online.
How will you raise money, equity or debt? Looking at the alternatives, no decision yet.
CMOs capable of making provenge? Yes, we used 2 CMOs in the U.S. before we began manufacturing our own.
See the accompanying press release: Dendreon Announces Plans to Seek Marketing Authorization for PROVENGE in Europe