The biotech sector can occasionally throw a curveball at investors. For Trius Therapeutics, Inc. (NASDAQ:TSRX) shareholders, they were staring at a meaty fastball right down the heart of the plate yesterday morning.
Tedizolid mops the floor with its competition Trius reported its late-stage results from its Establish 2 trial yesterday for Tedizolid -- its acute bacterial skin and skin structure infection, or ABSSSI, drug, which is also designed to treat methicillin-resistant staphylococcus aureus, or MRSA. MRSA is a highly infectious bacterial infection often contracted in hospitals, but also relatively treatable if caught early.
The results from Establish 2 only further established Tedizolid as a superior treatment for ABSSSI. Just as we saw in early and mid-stage trials, Tedizolid requires less dosing frequency and packed a bigger efficacy punch than Pfizer Inc. (NYSE:PFE)'s Zyvox, which has been the kingpin of ABSSSI treatments up until now.
According to Trius Therapeutics, Inc. (NASDAQ:TSRX)'s press release, Tedizolid met the primary endpoint of a greater than 20% decrease in lesion area size in a 48-hour to 72-hour period in 85.2% of instances compared with just 82.6% for Zyvox. Keep in mind, though, that the Tedizolid results were achieved after six days of treatment instead of the 10 days of treatment needed for Zyvox. Tedizolid met its secondary endpoints as well, including a sustained clinical response and an investigator assessment at the end of the therapy (usually seven to 14 days later). Even the adverse event profile of Tedizolid dipped compared to Zyvox, just 20.5% versus 24.8%. All evidence is now pointing to Trius filing for a new drug application in the U.S. and in Europe sometime in the second half of 2013.
Plenty of sales for Trius An FDA approval of Tedizolid could have a number of implications. For one, it completely mopped the floor with Zyvox in trials, which could make Pfizer Inc. (NYSE:PFE)’s ABSSSI drug nearly obsolete, assuming it gains approval in both the U.S. and E.U. Considering that Zyvox brought in $349 million last year worldwide, Trius Therapeutics, Inc. (NASDAQ:TSRX) could quickly see sales soar beyond $200 million within the first year.