Drug companies usually have a hard time recruiting cancer patients in clinical trials, and some dirty little financial reasons for it were exposed last week in The New York Times. Another little secret is that biotech companies often overpromise, and under deliver, when they tell investors they will hit their clinical trial deadlines.
That makes it all the more surprising to hear what’s going on at Bothell, WA-based Seattle Genetics (NASDAQ:SGEN). This company, the developer of an “empowered antibody” against Hodgkin’s disease, said recently its pivotal study is recruiting patients so fast that it is now six months ahead of schedule. That sets off a chain reaction that means it should have results sooner, apply for FDA approval quicker, and reach the market six months earlier, possibly as soon as the end of 2011.
Seattle Genetics has been able to pull this off because of pent-up demand from very sick patients with relapsed forms of Hodgkin’s disease, who are searching for new treatment options. Top cancer doctors hopped on the bandwagon after the American Society of Clinical Oncology meeting in June 2008, 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. The preliminary results for brentuximab vedotin (formerly known as SGN-35) started looking even better when longer-term follow-up data was presented at a medical meeting in December.
“More investigators wanted into the trial than we could really let in to participate,” said Tom Reynolds, the chief medical officer at Seattle Genetics, in an interview on Aug. 3. “You usually have to work really hard to get them interested. There seems to be a good buzz going in the oncology community.”
Investors like it too. JP Morgan analyst Cory Kasimov, a Seattle Genetics bull, headlined his note to investors on July 23 with “SGN-35 Momentum Continues to Pick Up Steam.” Seattle Genetics seized on some of that momentum this week, raising $118 million in a stock offering that priced yesterday afternoon.
Exciting as it all was, drug development is highly regulated and slow. But Seattle Genetics has been pushing hard to move as quickly as possible. One month after producing that stellar data at the American Society of Hematology in December, Seattle Genetics clinched an agreement with the FDA on … Next Page »