Dendreon Outlines European Strategy for Provenge
Jan07

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...

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Haystack 2010 Year-In-Review
Dec17

Haystack 2010 Year-In-Review

This Friday, we're looking back at 2010's big news in pharma and biotech, both the good and the bad. Check out our picks and be sure to weigh in on what you think we missed. 1. Provenge Approved In April, Dendreon's Provenge became the first approved cancer immunotherapy. Dendreon CEO Mitch Gold called it “the dawn of an entirely new era in medicine.” And while prostate cancer patients are excited for a new treatment option, the approval is perhaps most exciting for its potential to reignite interest in cancer immunotherapy research. There’s a lot of room for improving the approach—Provenge is, after all, expensive and highly individualized. Now that immunotherapy have been proven to work, there’s hope that the lessons learned in both its discovery and clinical development will aid scientists in inventing even better cancer vaccines. 2. Obesity Field Slims The obesity drug race played out in dramatic fashion in 2010, with three biotech companies-Vivus, Arena, and Orexigen, each making their case for its weight-loss medication before FDA. As of this writing, Orexigen's drug Contrave seems to be on the surest footing to approval, but longtime obesity-drug watchers know that caution seems to rule the day at FDA, so nothing is a sure bet. Orexigen's Contrave and Vivus's Qnexa are both combinations of already-approved drugs, whereas Arena's Lorqess is a completely new molecule. When C&EN covered the obesity race in 2009, it seemed that Lorqess (then going by the non-brand-name lorcaserin) had the cleanest safety profile, but Qnexa was best at helping patients lose weight. But FDA's panels didn't always play out the way folks expected. There were safety surprises- notably the worries about tumors that cropped up in rats on high doses of Lorqess, and the extensive questioning about birth defect risks from one of the ingredients in Vivus' Qnexa. The fact that FDA's panel voted favorably for Orexigen's Contrave, a drug that's thought to have some cardiovascular risks, generated discussion because FDA pulled Abbott's Meridia, a diet drug with cardiovascular risks, from the market in October. The dust still hasn't fully settled. Arena and Vivus received Complete Response Letters from FDA for Lorqess and Qnexa. Vivus has submitted additional documentation and a followup FDA meeting on Qnexa is happening in January. Also to come in January is the agency's formal decision on Contrave. And if you're interested in learning about the next wave of obesity drugs coming up in clinical trials, read this story in Nature News. 3. Sanofi & Genzyme: The Neverending Story Speaking of drama, Sanofi’s pursuit of Genzyme has been in the headlines for months now, and promises to stretch well into 2011. The...

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Provenge Becomes First Cancer Immunotherapy Approved
Apr29

Provenge Becomes First Cancer Immunotherapy Approved

Can you hear that? It’s the sound of champagne corks popping across Seattle today. Dendreon has at long last won FDA approval for its prostate cancer vaccine Provenge. Though not exactly a surprise, the regulatory nod it is still big news for Dendreon, which has struggled for years to bring the immunotherapy to market. In the broader scientific terms, Provenge will be the first therapeutic vaccine approved for cancer. On a conference call this afternoon, Dendreon’s president and CEO Mitchell Gold called it “the dawn of an entirely new era of medicine,” one in which a patient’s own immune system can be wrangled to combat cancer. Provenge works by prompting a patient’s immune system to wage its own battle against the disease. A blood sample is 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. Patients receive three doses of the vaccine over the course of a month. The vaccine has had its ups and downs. When we wrote a lengthy piece on cancer vaccines back in 2006, the field seemed on the cusp of a breakthrough with Provenge. Then, just a year later, FDA said it would need more data on the therapy. Patients were outraged, some claiming foul play by members of the agency's advisory panel. It wasn’t uncommon to see small groups handing out pamphlets or picketing at annual meetings of the American Society of Clincial Oncology. Dendreon preserved, running another trial and finally reaching the finish line. So now that the drug is finally available, down to the practicalities. First, how much will it cost? Speculation on this point had been rampant. Xconomy recently broke down different analyst estimates for price-per-patient, which ranged from $40,000 all the way up to $100,000. Today it became clear the biotech was aiming for the higher end of that range: Dendreon will charge $31,000 per infusion, and a full course of treatment typically calls for three infusions. Or, in the awkward—some might say grim--assessment by the company’s COO Hans Bishop, that’s $23,000 per month of life extension for these patients. Second, how many people will be able to get it? Dendreon said current capacity can accommodate 2,000 patients its first 12 months on the market. The biotech is launching the drug out of its N.J.-based facility, which it started...

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