Teva Pharmaceuticals (Nasdaq: TEVA) released results for its Bravo clinical trial this morning, but the only ones clapping were Biogen Idec's (Nasdaq: BIIB) investors.
Bravo tested Teva's oral multiple sclerosis medication laquinimod with a placebo and Biogen's Avonex. The drug didn't reduce annualized relapse rate compared with placebo by a statistically significant margin, but Teva says the patients in the laquinimod and placebo groups had different MRI characteristics and therefore different prognoses. If you make a statistical correction for the differences in the treatment groups, laquinimod produced a 21% reduction in the annualized relapse rate. Teva claims the adjustment was pre-specified, so the regulatory authorities should accept it, but it certainly doesn't sound as good as meeting the end point without statistical gymnastics.
In the trial, Avonex reduced annualized relapse rates, but that's not why Biogen's investors are happy. The company is developing an oral multiple sclerosis medication of its own called BG-12. The drug demonstrated a 53% reduction in annualized relapse rates, besting laquinimod even after the adjustment.
Laquinimod also passed a previous clinical trial, so Teva plans to submit marketing application in the U.S. and EU. At this point, whether the Food and Drug Administration or other regulatory authorities accept the statistical adjustment doesn't really matter; laquinimod is going to have a hard time competing with BG-12 for a spot in doctors' medicine bags.
In the oral multiple sclerosis space, that leaves BG-12 competing with Novartis' (NYSE: NVS) Gilenya, which is already approved, and potentially Sanofi's (NYSE: SNY) teriflunomide, although the latter didn't have the superb data that BG-12 put up. They'll all have the advantage of being taken orally compared with the current treatments like Avonex, Bayer's Betaseron, and Rebif sold by Pfizer (NYSE: PFE) and Merck KGaA that have to be injected or infused.
This is a big loss for Teva. It still has its injected multiple sclerosis medication, Copaxone, but one has to think BG-12 will start whittling into those sales.
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