Teva's oral MS drug clears a PhIII hurdle

Shares of Teva Pharmaceutical ($TEVA) surged this morning after it announced that a promising batch of late-stage data on its oral MS drug left it positioned for regulatory approval within two years.

For now, Teva is sticking with the top-line results from the two-year study, noting that patients taking 0.6 mg daily oral laquinimod "experienced a statistically significant reduction in annualized relapse rate compared to placebo. Additional clinical endpoints, including significant reduction in disability progression, as measured by Expanded Disability Severity Scale, were also achieved." Results from a second Phase III study are due out in the third quarter of 2011.

"This pivotal study met its primary endpoint while maintaining a very good safety profile," says Professor Giancarlo Comi, the principal investigator. "Laquinimod demonstrated a significant reduction in the progression of disability which may be explained by its unique mechanism of action that includes neuroprotective properties. Laquinimod may therefore be a promising therapeutic option for the MS community."

Laquinimod is one of several oral MS drugs in the pipeline. The recent approval of Gilenya has helped spotlight the potential of these new drugs, which are likely to command a significant share of the market. But at least a few analysts were left hungry for more details on Teva's data.

"The results seem very promising but we don't have details," Yoav Burgan, head of sell-side research at the Poalim Sahar brokerage, told Reuters. The details will come early next year. "Then, we will be much smarter." Teva shares jumped 6.5 percent on the news.

- here's the Teva release
- check out the Reuters story