) recently announced that it is moving forward with phase III
development of cadazolid in patients suffering from clostridium
difficile associated diarrhea (CDAD).
The decision comes after an exploratory phase II dose-finding
study was conducted. 3 doses of cadazolid (administered orally,
twice-daily) were evaluated for efficacy, safety and tolerability
for 10 days with ViroPharma's Vancocin (vancomycin) as an active
reference (125 mg administered orally, four times
Results showed that the effect of all doses of cadazolid were
either numerically similar or better than Vancocin on primary
endpoints, which included CDAD cure rates as well as sustained
The study also found that recurrence rates (a new episode of
diarrhea and a positive clostridium difficile toxin test) were
numerically lower for all doses of cadazolid versus
With these encouraging results in hand, Actelion is now moving
ahead with a phase III program for this new class of antibiotics.
The company intends to meet with health authorities to discuss
the details of the phase III program.
Meanwhile, competition will be stiff for cadazolid. While
ViroPharma already sells branded and authorized generic versions
of Vancocin in the US and its territories,
) Dificid gained US Food and Drug Administration (FDA) approval
in May 2011. Dificid was launched last year.
Nevertheless, we are impressed with Actelion's recent progress
with its pipeline. Last week, Actelion announced positive results
from a phase II study on its S1P1 modulator, ponesimod. Actelion
is evaluating ponesimod as a treatment for patients suffering
from moderate-to-severe chronic plaque psoriasis.
In addition, the FDA accepted Actelion's New Drug Application
(NDA) for macitentan. Actelion is looking to get macitentan
approved in the US as a treatment for patients suffering from
pulmonary arterial hypertension (PAH).
Actelion currently carries a Zacks #3 Rank (Hold). Pharma
) currently carry a Zacks #1 Rank (Strong Buy).
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