) recently announced encouraging data from a phase III study PATH
(Perindopril Amlodipine for the Treatment of Hypertension:
n=837), which evaluated the fixed-dose combination (FDC) of
perindopril arginine and amlodipine besylate in patients
suffering from hypertension.
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The phase III PATH trial, initiated in February 2012, compared
the efficacy and safely of FDC perindopril/amlodipine with
perindopril or amlodipine alone. Data from the study revealed a
statistically significant reduction in both sitting diastolic and
sitting systolic blood pressure in patients in the FDC arm
compared to those treated with perindopril and amlodipine alone.
The encouraging data from the phase III PATH trial is expected to
support the submission of the new drug application (NDA) to the
US Food and Drug Administration (FDA). FDC perindopril/amlodipine
is already marketed in 91 ex-US countries by partner Laboratoires
Servier, a privately-owned French pharmaceutical company, under
the trade name Coveram.
Notably, in January 2011, XOMA inked a deal with Les Laboratoires
Servier to acquire the US rights to the perindopril franchise
from the latter. The perindopril franchise includes Aceon
(perindopril erbumine), an angiotensin converting enzyme (ACE)
inhibitor and three other fixed dose combination candidates,
including FDC perindopril/amlodipine.
Aceon is approved for treating patients suffering from essential
hypertension. The drug is also marketed for reducing the risk of
cardiovascular death or nonfatal myocardial infarction in
patients with stable coronary artery disease.
XOMA has collaboration agreements with other companies like
Currently, we have a Neutral long-term recommendation on XOMA.
The company carries a Zacks #3 Rank (Hold rating) in the short