The US Food and Drug Administration (FDA) recently issued a
warning letter to
Alexion Pharmaceuticals, Inc.
) as the company did not comply with the current Good
Manufacturing Practices (cGMP) at its manufacturing facility at
Rhode Island. Alexion manufactures Soliris, its sole marketed
product, at the facility. The drug is available for the treatment
of paroxysmal nocturnal hemoglobinuria and atypical hemolytic
The US regulatory body issued a warning letter to Alexion Pharma
following its inspection of the facility last year. The FDA
issued a Form 483 Inspectional Observations to Alexion Pharma
following the completion of the inspection on Aug 6, 2012.
Alexion Pharma responded to the letter in the same month and
subsequently provided additional information to the US regulatory
body in Sep and Dec 2012.
However, the response did not satisfy the FDA which issued the
warning letter to the company. The FDA also remains concerned
about the quality system implemented by Alexion Pharma at the
facility. The FDA further stated while issuing the letter that it
is dissatisfied with the company's inadequate investigation of
bacterial contamination at its manufacturing facility at Rhode
The news had a negative impact on Alexion Pharma's shares. The
company intends to address the concerns raised by the FDA in the
warning letter. Alexion Pharma believes that the warning letter
issued by the FDA will not impact the supply of Soliris.
Though current supplies of Soliris may not be interrupted, we
believe further slipups by Alexion Pharma regarding Soliris will
invite stricter action from the FDA. This will be catastrophic
for the company since it is entirely dependent on Soliris for
Alexion Pharma carries a Zacks Rank #3 (Hold). Favorably
placed stocks in the pharma space include
Osiris Therapeutics, Inc.
). All three stocks carry a Zacks Rank #1 (Strong Buy).
ALEXION PHARMA (ALXN): Free Stock Analysis
ATHERSYS INC (ATHX): Free Stock Analysis
CYTOKINETCS INC (CYTK): Free Stock Analysis
OSIRIS THERAPTC (OSIR): Free Stock Analysis
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