) recently announced encouraging results from two ongoing phase
II studies on its pipeline candidate, maribavir.
We note that ViroPharma is evaluating maribavir for as a first
line treatment of cytomegalovirus (CMV) viremia as well as for
the treatment of resistant/refractory CMV.
ViroPharma had initiated the 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 European study is focused on hematopoietic stem cell or
solid organ transplant recipients, who carry CMV viremia but do
not have CMV organ disease; However, the study in the US is
focusing on patients, who have resistant or refractory CMV
viremia with or without CMV organ disease. Additionally,
ViroPharma is conducting a resistant/refractory study in
Preliminary data from both studies was positive and
demonstrated a favorable safety and tolerability profile.
Moreover, the data was consistent with previous clinical studies
conducted by ViroPharma.
The positive interim data from both these studies are
encouraging for ViroPharma. 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 lower dose. The
company also discontinued a study evaluating maribavir in liver
Last month, ViroPharma received 'orphan drug designation' for
maribavir in Europe for the treatment of CMV in patients
suffering from impaired cell mediated immunity.
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 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
) look attractive. Both carry Zacks Rank #1 (Strong Buy).
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