Seattle Genetics has spent more than a decade thinking about cutting-edge biology, chemistry, and clinical trials to prove its drug candidates work. Then last week, for the first time in nine years I’ve been reporting on CEO Clay Siegall, he talked with passion about things like manufacturing, inventory, quality assurance, quality control, and insurance reimbursement.
It all might sound awfully boring. But it’s a sure sign that Bothell, WA-based Seattle Genetics (NASDAQ: SGEN), with help from its partner Millennium: The Takeda Oncology Company, is learning fast what it takes to be a mature, commercial biotech company. And while it may be a slow news period for Seattle Genetics (NASDAQ: SGEN), it has to grow up in a hurry, because it is only a few months away from finding out if it has really struck gold with a new therapy for Hodgkin’s disease and related lymphomas.
The big story at Seattle Genetics and Millennium centers on brentuximab vedotin, an “empowered antibody” that specifically seeks out cancer cells and unleashes a potent toxin on them for extra tumor-killing punch. This concept has not lived up to its hype over the past 30 years, but by the second half of 2010, Seattle Genetics and Millennium will learn from a pivotal clinical trial of 100 patients how well this therapy really helps sick patients. If successful, the companies will be able to seek FDA approval in early 2011, and potentially get a faster-than-usual six-month review that the agency sometimes gives to drugs with lifesaving potential. Patients, employees, investors, and an entire field of research is counting on Seattle Genetics and Millennium to deliver the goods. So Siegall & Co. are quietly trying to lay the groundwork now to make sure they are truly ready to make sure this drug is a hit.
“Our drug has a chance to be a very important drug for patients,” Siegall says.
For those just getting up to speed on this story, here’s a quick refresher. Seattle Genetics, founded in 1998, had its breakout moment in June 2008 at the American Society of Clinical Oncology meeting. That’s when the company released preliminary results showing its experimental treatment was able to completely wipe out or partially shrink tumors for 12 of 38 patients, with mild to moderate fatigue, cough, and nausea as side effects. Results only got better when researchers enrolled a few more patients, and longer-term follow-up data arrived.
A lot of things have fallen into place for Seattle Genetics as a business ever since that appearance at ASCO. It raced to the FDA in early 2009 with a proposal for a pivotal clinical trial, and won the agency’s blessing for the study design. The company got this trial up and running at 27 locations in North America and Europe, and completed enrollment six months ahead of schedule—a lightning pace in oncology, where it’s extremely difficult to enroll patients on time. The company raised more than $200 million from investors in 2009, during a dark period in the overall biotech financial market. In December, Millennium wrote a $60 million upfront check to Seattle Genetics to form a partnership, which left the smaller company with 100 percent of the commercial rights to the experimental drug in the North American market.
Much of what has happened since then has been the sort of behind-the-scenes blocking and tackling that biotech companies need to do, and often fail to do, as they prepare to commercialize a new drug. Part of that effort is in hiring new types of people, with skills in things like 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.”