With Thanksgiving approaching, it's time for investors and commentators to take stock (pun intended) of the rapidly ending year and look ahead with predictions for the next 12 months.
This week, I want to highlight what were, for me, some of the biggest surprises in the biotech sector of 2013 and speculate about what those same events might look like in 2014. Next week, I'll offer my own biotech stock predictions for 2014 -- a list that will surely come back to haunt me 12 months from now.
Surprise No. 1 of 2013: The blow-up of approved, marketed drugs due to safety problems. Ariad Pharmaceuticals' (ARIA) leukemia drug Iclusig pops immediately to mind in this category, but don't forget Affymax's anemia drug Omontys, no less of a disaster from earlier in the year. One doesn't usually plan for commercial-stage biotech companies completely blowing up, but that's exactly what happened to Ariad and Affymax to the surprise of most investors. The risk of a drug failure is something we more often associate with clinical trials, not drugs that make their way successfully through clinical trials and the FDA approval process. Yet in 2013, Ariad and Affymax managed to snatch failure from the jaws of victory.
Is there an Ariad/Affymax lurking in 2014? I don't believe there is, but press me and I'll say Seattle Genetics (SGEN) and its lymphoma drug Adcetris. I own Seattle Genetics so I'm not here to instill panic. Nonetheless, the bear thesis on Adcetris does focus, in part, on the drug's safety. An Adcetris study was halted temporarily in June due to reports of pancreatitis and the drug has been linked to cases of progressive multifocal leukoencephalopathy (PML). Again, I believe the risk of Seattle Genetics falling into the same deep, dark hole as Ariad and Affymax is exceedingly small -- under 1% -- but as we learned this year, nothing is impossible.