Alexion Pharmaceuticals, Inc. (ALXN - Free Report) 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.
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 country.
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 Actelion Ltd. , Biogen Idec Inc. (BIIB - Free Report) and Gilead Sciences Inc. (GILD - Free Report) , carrying a Zacks Rank #1 (Strong Buy), currently look more attractive.