Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech recently announced that they intend to commence a phase III study with their oral multiple sclerosis candidate, laquinimod. The study will be conducted under the US Food and Drug Administration’s (:FDA) Special Protocol Assessment (SPA) program.
The phase III study, CONCERTO, will be conducted in patients with relapsing-remitting multiple sclerosis (RRMS). Two doses of laquinimod (0.6 mg and 1.2 mg) will be evaluated in the study for up to 24 months with the primary endpoint being confirmed disability progression as measured by the Expanded Disability Status Scale (:EDSS).
Laquinimod has been evaluated in two other phase III trials (ALLEGRO and BRAVO) earlier. The candidate is also being studied for Crohn’s disease and lupus.
The successful development and launch of laquinimod would help strengthen Teva’s multiple sclerosis drug portfolio. Being an oral formulation, laquinimod could provide an advantage over therapies that require injection or infusion.
Teva already has a multiple sclerosis product in its portfolio – Copaxone. Copaxone is approved for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis (RRMS), including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
Teva received some good news on the Copaxone patent infringement lawsuit front recently with favorable court rulings in the UK and the US. With these rulings, Copaxone should be protected from generic competition until September 2015.
The favorable rulings are a major positive for Teva. With Copaxone contributing 19.5% to total revenues in 2011, the earlier-than-expected entry of generic versions would have been a major setback for the company. Teva can now focus on extending Copaxone’s life cycle.
We are pleased with Teva’s efforts to expand its multiple sclerosis franchise. The multiple sclerosis market represents significant commercial potential. The disease is estimated to affect more than 400,000 people in the US. Worldwide, it is estimated that more than two million people may be suffering from multiple sclerosis.
We currently have a Neutral recommendation on Teva, which carries a Zacks #3 Rank (short-term Hold rating).
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