Synribo Approval Does Little for TEVA; Second CML Drug Approved Since September

Despite a new drug approval on Friday, Teva Pharmaceuticals (NYSE:TEVA) declined slightly in the trading session. The FDA approved Synribo as a treatment for Chronic Myeloid Leukemia (CML) in patients who have become resistant to two or more tyrosine kinase inhibitors (TKIs). Primary TKI treatment options include Gleevec (imatinib) and Tasigna (nilotinib), developed by Novartis (NYSE:NVS), and Sprycel by Bristol-Myers Squibb (NYSE:BMY). Interestingly, Synribo was approved as an orphan drug with an accelerated approval that allowed for submission without pivotal Phase 3 data. The FDA approved the drug, which is a protein synthesis inhibitor, based on patient response rate in two Phase 2, open-label studies.

The market’s negative reaction Friday is due in part to the low rate of utilization that Synribo will see. While CML presents a substantial market, the number of patients who develop resistance or are intolerant to two TKI’s and standard cancer therapies is small, and product sales aren’t likely to impress. Synribo won’t be a major value-driver for Teva, especially with the treatment landscape changing significantly. ARIAD Pharmaceuticals (NASDAQ:ARIA) is pursuing an approval for ponatinib, first as a second-line CML treatment, with hopes for a first-line indication to follow. And Pfizer’s (NYSE:PFE) Bosulif just received approval in September as a treatment for advanced CML, or in cases where patients are intolerant to other options. That said, CML remains a large market, Teva just won’t be taking a large portion of the action. Read more about ponatinib and ARIAD’s early-stage compounds by clicking here.