Dendreon Outlines European Strategy for Provenge
Getting ahead of the crush of biotech news likely to come out of next week’s J.P.Morgan Healthcare conference, Dendreon held a conference call this morning to outline its strategy for the European launch of its prostate cancer immunotherapy Provenge.
If you'll recall, last April, Provenge became the first cancer immunotherapy approved in the U.S. Launching the drug in Europe would be a boon for Dendreon. As the biotech’s CEO Mitch Gold pointed out on the call, low rates of PSA testing in Europe meant that many men arrived in their physicians office with metastatic disease. As a result, Europe has the largest metastatic castrate-resistant prostate cancer population—the same population Provenge is approved to treat--in the world. That said, Dendreon expects the actual market size to be more in line with the U.S., due to the challenging reimbursement environment in Europe.
The majority of the call was focused on the company’s manufacturing plan in Europe. As we wrote several years back, it's a highly personalized treatment with a complicated manufacturing process:
The personalized component comes from a blood sample taken from a patient in order to isolate dendritic cells, which deliver antigens to T-cells and B-cells, the lymphocytes that control the immune response. Those dendritic cells are then cultured with the general component, prostatic acid phosphatase, a recombinant protein found in 95% of prostate cancers. The dendritic cells, now loaded with the antigen, are then injected back into the patient to trigger a reaction from the immune system.
Indeed, the roadblock to the treatment’s growth in the U.S. has been Dendreon’s ability to expand its manufacturing capacity here, and it wants to be ready to hit the ground running in Europe.
The first goal is to enlist a contract manufacturing organization in Europe to make the treatment. Having someone on the ground will enable Dendreon to file its marketing authorization application in Europe much faster than if it was building from the ground up. It will also allow the biotech to start European trials of Provenge—a move management reminded investors was not necessary for the MAA filing, but would help give physicians some hands-on experience with the treatment before its approval.
At the same time, Dendreon will this year start construction on its own immunotherapy manufacturing facility in Germany. The biotech notes that because Europe is so much more compact than the U.S., half the patient population will be within an eight hour drive of that site.
If all goes well, the biotech plans to file for approval in Europe in late 2011 or early 2012, a timeline dependent on how fast it can transfer its manufacturing technology to a CMO. That puts a decision from EU authorities in the first half of 2013, around the same time Dendreon expects to be able to open up its German site.
All this expanding comes at a price: Dendreon will spend $125 million this year in preparation for the European launch, and says it will need to raise additional capital to meet that goal.
The good news is that the U.S. sales of Provenge should substantially open up this year as hundreds of infusion sites come online. The immunotherapy should bring in between $350-$450 million this year, with half of those sales coming in the fourth quarter when widespread manufacturing is up and running. By comparison, Provenge sales were roughly $25 million in the fourth quarter of 2010.
*Updated at 12:17 to reflect that hundreds of infusion, not manufacturing sites coming online in the U.S. this year