Teva and other pharmaceutical companies have been trying to develop oral versions of multiple sclerosis drugs for years.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Active Biotech (Nasdaq; OMX: ACTI) reported success in the Phase III Allegro Clinical trial of Laquinimod, the oral version of multiple sclerosis version drug Copaxone. Laquinimod was safe and well-tolerated.
Copaxone is Teva's flagship product, responsible for almost 30% of its revenue. Copaxone is injected; oral Laquinimod is considered the next-generation Copaxone. Teva and other pharmaceutical companies have been trying to develop oral versions of multiple sclerosis drugs for years. In September, the US Food and Drug Administration (FDA) approved Novartis AG's (NYSE:NVS; LSE: NOV; SWX: NOVZ) oral multiple sclerosis, Gilenya.
Teva's clinical trial took two years. Patients treated with 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 (EDSS), were also achieved.
The overall frequencies of adverse events were comparable to those observed in the placebo group. No deaths were reported in laquinimod-treated patients. Overall incidence of infections was similar between the two arms of the trial.
"This pivotal study met its primary endpoint while maintaining a very good safety profile," said Professor Giancarlo Comi, director of the Department of Neurology and Institute of Experimental Neurology at the University Vite Salute at San Raffaele, Italy, who was the principle investigator in the trial. "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."
Teva president and CEO Shlomo Yanai said, "We are very pleased to have achieved this major milestone in the development of oral laquinimod, a novel therapy that can potentially improve the lives of many MS patients in a safe way."
Teva said that it will submit additional analysis of the Allegro study at a leading scientific conference during the first half of 2011. The second phase III clinical trial, is still ongoing, and Teva expects results in the third quarter of 2011, after which it will submit regulatory documentation with the FDA and European Medicines Agency (EMEA).
Laquinimod is also undergoing a Phase II development for Crohn's disease and Lupus, and is being studied in other autoimmune diseases.
In a special investment report on Teva, "Barron's" wrote that Teva will double in size over the next five years as the company dominates the generic-drug industry that could almost double by 2015. It adds that Teva is fundamentally undervalued.