How big is the Tedizolid market ? $40 Million per year ?
How big is the Tedizolid market ?
Pending final agreement with regulatory authorities, Trius plans to initiate a Phase 3 program for the treatment of pneumonia in the second half of 2013 using the same 200 mg, once daily dose of tedizolid phosphate that is currently being tested to treat skin infections. In addition, the Company is progressing with enabling studies for an Investigational New Drug (IND) application for its Gyrase-B development candidate with potent activity against Gram-negative and Gram-positive bacterial pathogens. A Phase 1 clinical trial is expected to start in 2014
We believe the commercial opportunity for Trius' tedizolid is significant, at roughly $750 million worldwide. We see the story as mostly derisked, given the positive and consistent results from the two phase 3 studies, ESTABLISH-1 and ESTABLISH-2, that show tedizolid is non-inferior to Pfizer's (NYSE:PFE) $1.3 billion drug, Zyvox (linezolid). We believe tedizolid can gain meaningful market share after commercialization based on superior dosing, safety, tolerability, and potentially improved efficacy in a growing number of vancomycin and linezolid-resistant strains.
Trius plans to file the U.S. NDA application during the second half of 2013. We see $12 as fair-value and believe the name is low risk / high reward at this level.