Teva ($TEVA) and its multiple sclerosis partner Active Biotech rolled out some new top-line Phase III data on their troubled program for the oral MS drug laquinimod--still Teva's best shot at protecting the $4 billion franchise built up for Copaxone. But the results from the three-year study are unlikely to change anyone's mind about its long-term commercial prospects.
The Phase III study was used to compare the efficacy of laquinimod in delaying disease progression when provided in an early start effort over 36 months versus a late-start group treated for 24 months. Not surprisingly, the early-start group experienced the better results--11.8% risk of confirmed disability progression versus 16.7%.
For the investigators the ALLEGRO study offered a chance to demonstrate the potential of the drug in delaying disease progression. But with new therapies like BG-12 (Tecfidera) from Biogen Idec ($BIIB) nearing the market, analysts will be waiting for much more persuasive evidence of efficacy.
Doubts about laquinimod grew after the drug failed to achieve a primary endpoint in reducing the rate of relapses in patients in an earlier study. But rather than bury the program, which inspired investigators with early signs of impressive activity, Teva doubled down and came back with a new Phase III study designed to demonstrate that a higher dose of the drug delays the progressive loss of muscle control. Investigators began dosing a few days ago.
While Teva has been struggling with laquinimod, Biogen Idec has been developing a strong position to launch oral Tecfidera. The biotech is widely expected to gain an approval for the treatment in just days. And that would add an important new MS treatment for a company that also controls the market for Tysabri. Teva is likely to feel considerable market heat from Biogen in the near future.
- here's the release from Teva
- see the Dow Jones report