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 … Next Page »