Alexion Pharmaceuticals, Inc.
) announced that encouraging interim data from an ongoing phase
II study on its pipeline candidate asfotase alfa was presented by
researchers. The study evaluated the candidate in infants and
young children suffering from HPP-an ultra-rare metabolic
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Results from the study revealed that treatment with asfotase alfa
for 24 weeks caused a significant improvement in skeletal
mineralization of the disease over time. Alexion stated in its
press release that the favorable response was detected following
only 12 weeks of asfotase alfa therapy and the patients continued
to show improvements at 48 weeks. Data from the open-label study
also revealed that majority of the patients treated with asfotase
alfa improved or preserved respiratory function at 48 weeks with
over survival rate of 93%. Moreover, the candidate was found to
be safe and well tolerated in the interim analysis.
We note that asfotase alfa enjoys Breakthrough Therapy
designation from the U.S. Food and Drug Administration for
treating patients suffering from hypophosphatasia. The
designation is part of the FDA Safety and Innovation Act of 2012.
The symptoms were witnessed in patients prior to attaining
adulthood. Alexion Pharma stated in its press release that the
status is assigned to speed up the development of the drug for
treating a serious or life-threatening disorder. Successful
development and commercialization of asfotase alfa would broaden
Alexion's product portfolio and bring in additional revenues to
Alexion, which currently is a one-drug company with Soliris being
its sole marketed product, is working on developing its pipeline
to reduce its dependence on Soliris. Alexion's pipeline includes
ALXN1102/ALXN1103 (hematology) and ALXN1007 (inflammatory
disorders) apart from asfotase alfa.
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).