Good news flowed in at
Alexion Pharmaceuticals, Inc.
) from Japan when the country's Ministry of Health, Labour and
Welfare approved the company's sole marketed product, Soliris
(eculizumab), for treating patients suffering from atypical
hemolytic uremic syndrome (aHUS). We note that aHUS is an
ultra-rare chronic genetic disease that can prove to be fatal in
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Alexion had filed for approval of Soliris for treating aHUS on
the basis of encouraging data from five studies. Two of the
studies evaluated adults and pediatrics suffering from aHUS and
another (a retrospective study) studied Soliris on aHUS children.
Japanese approval was also sought on the basis of data from an
ongoing prospective study in addition to a retrospective study on
Soliris in patients (adults and pediatrics) suffering from aHUS.
Alexion expects to launch Soliris for treating aHUS patients in
Japan by year end.
Apart from Japan, Soliris is approved for treating aHUS in the
U.S., EU and many other countries. The U.S. and EU approvals for
the indication came in 2011. The Japanese approval of Soliris for
treating aHUS patients will boost the drug's sales potential
further. The drug recorded sales of $1.13 billion in 2012, up
Soliris is also available in multiple countries, including Japan,
for treating patients suffering from paroxysmal nocturnal
hemoglobinuria (PNH). PNH is a rare genetic blood disorder
characterized by the onset of severe hemolytic anemia, chronic
fatigue and intermittent episodes of dark urine, known as
Alexion is working on expanding Soliris' label into additional
indications like Shiga-toxin producing E. coli hemolytic uremic
syndrome and myasthenia gravis. Alexion's pipeline also includes
asfotase alfa, ALXN1102/ALXN1103 and ALXN1007.
Alexion currently carries Zacks Rank #3 (Hold). Stocks which
appear to be more attractive, include
Gilead Sciences Inc.
Biogen Idec Inc.
), each with a Zacks Rank #1 (Strong Buy).