Teva Pharmaceutical Industries Ltd.
) 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
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
Key players in the multiple sclerosis market include
) among others.
We currently have a Neutral recommendation on Teva, which
carries a Zacks #3 Rank (short-term Hold rating).
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