Seattle Genetics isn’t saying much about the next steps for SGN-35, because the company is still working on a plan with the FDA. Reynolds says he’s learned a lot from his experience over the years with the U.S. drug regulator. “There’s a lot of mistakes companies can make. One is when companies have some feeling that if you and the FDA don’t agree, and you think you’ve got your science right, you’ll win. That you’ll just ram it down their throats and win. Experience says that doesn’t work,” he says. “We don’t believe we can tell the FDA what to do. We seek a win-win.” He added: “It’s really a lot about attitude. We’re not going in there to tell them what to do or to pull the wool over their eyes.”
He made it clear the company intends to spend money to get the full answer about SGN-35, rather than cut corners with a smaller trial that gives some, but not all, of the information needed to say it’s a real drug. CEO Clay Siegall, a founder of the company and an Xconomist, has given Reynolds the resources to do the job. The company’s clinical group has grown from 22 when Reynolds started to 70 people now. “Clay wanted to hire someone to build what we needed to go the distance,” Reynolds says.
Going the distance means doing studies the right way, he adds. “We don’t do Hail Marys, and we don’t bet the company on one product,” Reynolds says. “We’re moving toward a Genentech-type approach on when you do the right studies.”
The company expects to unveil its plan for the right study for SGN-35 before the end of the year. Open for discussion with the FDA right now: the choice of dose, the treatment schedule, the patient population, whether patients are randomized to the drug or a control group, and what the key measurement of success will be. Getting those moving parts all properly aligned, and then carrying out the trial so it can go all the way to approval, is something few biotech companies ever get right. Wall Street seems to like the odds for now, but it will be a long time before we really find out whether Reynolds and his team have made all the right moves.
