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quality assurance, regulatory affairs, and quality control that weren’t really necessary in the early years of the company, Siegall says.
The Seattle Genetics payroll, which had just 189 people at the last official count before the June 2008 breakout moment at ASCO, has climbed now to about 310 people. The headcount could go as high as 400 people a year from now if everything goes according to plan, Siegall says.
Much of their effort is going into meetings with Millennium to figure out how to best maximize the potential of brentuximab vedotin, Siegall says. One example was the initiation of a trial called “Aethera.” The main purpose of this study, of more than 320 patients, will be to show the new drug is valuable not just for the sickest of the sick who have run out of other options, but that it also works for larger numbers of patients with earlier-stage forms of Hodgkin’s disease. There’s a trial for patients with another rare disease, anaplastic large cell lymphoma, that carries the same target on malignant cells, called CD30.
Millennium, which has global experience with a $1 billion blockbuster called bortezomib (Velcade), has played a key role in honing the strategy of how to start with one disease, and build from there to make the drug a much bigger seller, Siegall says. Millennium has gone so far as to tell my Boston-based colleague, Ryan McBride, that it believes brentuximab vedotin could be useful for patients with autoimmune diseases, because of its high potency and mild side effect profile for a cancer drug.
“They have been through this kind of planning exercise before,” Siegall says. “They understand what they are doing. They are pros. This is our first product that we plan to launch as a company.”
All that said, Siegall noted that he has been recruiting lots of industry vets for his own talent stable. One person he pointed to, which sort of symbolizes a new breed at Seattle Genetics, is Bruce Seeley, his executive vice president of commercial operations. Seeley comes to this job from Genentech, where he was a senior director for marketing of its breast cancer blockbuster drug trastuzumab (Herceptin), and its “empowered antibody” successor, known as T-DM1. Seeley’s imprint was felt at a recent company meeting in which he started talking about how Seattle Genetics needs to make sure that its drug will get to every patient who wants and needs it, regardless of their ability to pay. This drug will surely cost a small fortune, and any company that blindly ignores critics of drug pricing is setting itself up for some major headaches.
“We’re not naïve,” Siegall says.
Siegall, a great admirer of Genentech, also pointed out one of the things he has learned from that company’s playbook which is being applied to brentuximab vedotin. This is the idea of using the new drug in repeated courses of therapy. This practice, of knocking down a malignancy and then delivering another round to the patient at the time of a relapse, has great appeal to oncologists who like to know they have another arrow left in their quiver just in case a patient turns for the worse. This approach has been one of the important factors in the success of Genentech and Biogen Idec’s hit lymphoma drug, rituximab (Rituxan).
A few anecdotal cases of data on this re-treatment idea will be presented on brentuximab vedotin next month at the ASCO meeting. More rigorous data to answer this question will come later, Siegall says. If this can be proven to be useful, and Seattle Genetics and Millennium can execute their entire vision, brentuximab vedotin could potentially be used in newly-diagnosed patients, and could eliminate the need for radiation, Siegall says. A few leading physicians have “bandied around” the idea that brentuximab vedotin is so powerful that it might be able to eliminate at least a couple components of the four-drug chemo regimen that most patients have to endure today, Siegall says.
It’s a lot to process at once, for a company that simply used to be about R&D. Now it’s about planning ahead to make sure it’s ready to handle success.
“We need to make sure we’re thoughtful about this,” Siegall says. “It’s a balancing act, making sure we have the resources applied right.”