Dendreon Plans to Go It Alone in Europe, Build Provenge Factory in Germany
Dendreon took a big leap ahead last year when its new immune-boosting therapy for prostate cancer hit the U.S. market. Now in 2011, it is mapping out plans to take this new mode of treatment into the European Union for the first time.
The Seattle-based biotech company (NASDAQ: DNDN) said today that it plans to put together a new drug application for the approval of sipuleucel-T (Provenge) in Europe by the end of 2011 or in early 2012. Based on preliminary talks with regulators there, the company said it expects the same 512-patient trial that clinched Provenge’s approval in the U.S. ought to be good enough to seek approval in the EU as well. Dendreon also plans to build its own factory in Germany to serve the European market, based on a distribution model similar to the one used by its plants under construction in Los Angeles and Atlanta. The drug could be cleared for sale in Europe by the first half of 2013, the company said.
“As we leverage our success in the U.S., we are encouraged and enthusiastic about the European Union,” said Dendreon’s chief operating officer, Hans Bishop, on a conference call with analysts this morning.
Dendreon has talked to investors about the potential in Europe, and whether it might seek help from a partner there. That never happened. Dendreon, which owns 100 percent of the commercial rights to its cancer drug in the U.S., has been making signals for at least a year about how it has had its eye on taking its drug to Europe, potentially on its own.
Bishop, in particular, is a native of Britain with international pharmaceutical experience at Bayer. In his first interview with Xconomy when he was just getting started at Dendreon a year ago, Bishop noted that Europe has 150,000 to 200,000 patients with the form of prostate cancer that Provenge is designed to treat—cancer which has spread through the body and no longer responds to hormone deprivation therapy. That population represents about 1.5 to two times as many such patients as there are in the U.S. Now that Dendreon has started talking to regulators in Europe, it says it got the information it needs to form its own plan to tackle that market.
The international expansion, though, will require Dendreon to raise more capital, finance chief Greg Schiffman told analysts. He didn’t say how much money it would take, or how long that might delay the company on its quest to eventually reach profitability. The drug’s price—at $93,000 for a full course of therapy in the U.S.—should be comparable in Europe, Bishop said.
But by forsaking a partner, Dendreon, naturally retains all the upside of the product for itself. For those following the story, the company also has an unusual product that doesn’t easily fit into any prospective partner’s portfolio. It’s a process that requires blood to be drawn from a patient, certain white blood cells get filtered out, and shipped to a Dendreon factory where they are “taught” to recognize a marker found on prostate cancer cells. Once this incubation process is complete, the cells are shipped back to the doctor and they are re-infused into the patient so the patient’s own immune system reacts to fight the cancer. It’s a completely new mode of therapy, a process that Dendreon developed on its own.
Dendreon had a few other things besides its European plan to talk about with investors this morning, in a public conference call before it has a series of one-on-one meetings with investors next week at the JP Morgan Healthcare Conference in San Francisco.
First, the company said it generated Provenge sales of about $48 million in its first year, and $25 million of that came in the final three months. That performance is limited by constraints on its manufacturing capacity at the moment, as it finishes expansion work at its factories in New Jersey, Los Angeles, and Atlanta.
Dendreon said it still expects to sell about $350 million to $400 million worth of Provenge in the U.S. this year. While Dendreon continues to build up its sales, marketing, and manufacturing capabilities, it expects to lose about $310 million to $350 million this year when measured by generally accepted accounting principles, according to Schiffman, the finance chief.
The company also had a little bit to say to analysts today about the future beyond Provenge. Dendreon filed an application to start a new trial of a therapy that’s designed to stimulate the immune system in a similar way, but aimed at a different target, Her2neu, that’s relevant to patients with bladder cancer. That trial is expected to enroll 180 patients, and randomly assign them to the Dendreon treatment or a control group, to measure the difference in patients’ survival time, CEO Mitch Gold said on the call with analysts.
The plan to boost sales in the U.S., start moving seriously toward Europe, and building enthusiasm for the second coming of Provenge will certainly give the Dendreon execs a lot to chat about as they meet with investors next week at the JP Morgan Healthcare Conference.
“2011 is a year we are establishing a foundation for growth,” Gold said.
The company’s stock climbed 2 percent to $36.14 at 10:37 am Eastern time after the news.