) recently received 'orphan drug designation' in the EU for its
pipeline candidate, maribavir, for the treatment of
cytomegaloviral (CMV) in patients suffering from impaired cell
We note that maribavir was granted the same designation in the
US in May 2011 for the treatment of clinically significant CMV
and disease in at-risk patients.
We remind investors that ViroPharma was previously developing
maribavir as an anti-CMV agent to prevent CMV disease in
transplant patients. However, results from phase III studies
showed that maribavir failed to meet its efficacy endpoints at a
Nevertheless, studies are ongoing as ViroPharma expects that
higher doses might provide clinical activity based on overall
safety profile of maribavir and limited data from cases in which
open-label maribavir was used as CMV treatment.
The company also discontinued a study evaluating maribavir in
liver transplant patients.
ViroPharma initiated two phase II studies in 2012 to evaluate
maribavir at different doses for the treatment of CMV infections
in transplant recipients. The studies are being conducted in
Europe and the US.
The study conducted in Europe focuses on hematopoietic stem
cell or solid organ transplant recipients who carry CMV viremia
but do not have CMV organ disease, whereas the study in the US
focuses on patients who have resistant or refractory CMV viremia
with or without CMV organ disease.
We note that ViroPharma acquired global rights to maribavir
(excluding Japan) in 2003 from
We note that
) Valcyte is approved for the prevention of CMV disease in
patients who have undergone a heart, kidney, or kidney-pancreas
ViroPharma currently carries a Zacks Rank #3 (Hold). Right
) looks attractive with a Zacks Rank #1 (Strong Buy).
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