Alexion Pharmaceuticals, Inc.
) recently announced preliminary results from a single-arm phase
II study (n=47) on Soliris, being developed to prevent acute
antibody-mediated rejection (AMR) in sensitized deceased-donor
kidney transplant recipients.
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Alexion presented results from this study at the 2013 annual
congress of the European Society for Organ Transplantation.
Results from the study revealed that post-transplantation
treatment failure occurred in 10.6% patients. This included a
6.4% rate of AMR1 in these kidney transplant recipients in
comparison to an expected 30% rate of AMR2. Alexion intends to
continue enrolling patients for the study. Alexion mentioned in
its press release that currently there are no approved treatments
for the prevention of acute AMR. We note that Soliris is not yet
approved for the prevention of AMR indication in any other
We also note that Soliris is approved in more than 40 countries
including the U.S. and the EU for the treatment of paroxysmal
nocturnal hemoglobinuria (PNH). The drug is also available in the
U.S., EU and other countries for the treatment of atypical
hemolytic uremic syndrome (aHUS). Soliris enjoys orphan drug
designation for both these indications in the U.S. and the EU.
Alexion's revenues jumped 35% to approximately $370.1 million in
the second quarter of 2013 driven by strong Soliris sales.
Approval of the drug for additional indications will boost sales
of the drug further.
Alexion currently carries a Zacks Rank #3 (Hold). Meanwhile,
stocks such as
Biogen Idec Inc.
Gilead Sciences Inc.
), carrying a Zacks Rank #1 (Strong Buy), currently look more