This Week in Biotech: Let's Get Clinical!http://www.fool.com/investing/general/2014/02/01/this-week-in-biotech-lets-get-clinical.aspx Sean Williams
February 1, 2014
With the SPDR S&P Biotech Index up 58% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.
The good news is that we weren't completely overwhelmed with biotech news, aside from earnings reports, this week – meaning no two-part series! But, rather than focusing on earnings news, which we at The Motley Fool have been hitting this week with some regularity, I'd rather focus on the important clinical news which made waves this week. All told, five events -- four being clinical updates -- helped induce big moves this week.
The overall results demonstrated a sustained virologic response (i.e., undetected levels of disease) within 12 weeks (one study tested SVR at 24 weeks) in 90% to even 100% of patients. Common SVR response was 96% to 99% in treatment-naïve patients and 92% to 96% in cirrhotic patients. This is also great news for Enanta Pharmaceuticals which contributes one of the three DAA components, ABT-450. AbbVie now anticipates a possible Food and Drug Administration approval before 2014 is over -- and barring an unforeseen curveball, I'd have to agree.
On Wednesday, Medivation and its partner Astellas Pharma announced the results from their PREVAIL trial noting that Xtandi reduced the risk of death by 29% relative to the placebo group and significantly reduced the risk of radiographic progression by 81%. Perhaps the most striking tidbit of data was the delay in the initiation of chemotherapy from 10.8 months in the placebo group to 28 months in the Xtandi intent-to-treat arm. The ability to treat patients with Xtandi was also more than three times longer at 16.6 months compared with 4.6 months for the placebo group. Given this data, it's looking incredibly good for Medivation and Astellas that Xtandi will soon be approved in a pre-chemo setting for treating advanced-stage prostate cancer.
Hold the Mayo
Nonetheless, Geron is planning to begin phase 2 trials involving imetelstat soon and announced a $90 million common stock offering late in the week which sent its shares soaring. As I said, it was an odd week. I'm certainly not buying into the dilution factor here and would need to see concrete data on adverse events versus efficacy with regard to imetelstat before I'd buy into the Geron hype.
The concern that sent shares markedly lower was an abstract that came out