In a filing with the Securities and Exchange Commission (SEC),
Alexion Pharmaceuticals, Inc.
) stated that it has initiated a recall and replacement of the
remaining vials of a single lot of the company's sole marketed
drug Soliris. Alexion further stated that this voluntary move was
prompted by the presence of visible particles in a few vials in a
solitary lot of the drug. Soliris is available for the treatment
of paroxysmal nocturnal hemoglobinuria and atypical hemolytic
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According to Alexion, the recalled and replaced vials accounted
for a negligible portion (1-2%) of the vial consumption in a
month. The affected vials were being replaced in hospitals. The
company also stated in its filing with the SEC that it observed
the particles during its regular testing of retained
samples after the filling, packaging, and labeling of the
vials by a third party contract vialer. Alexion said that the
affected lot was filled in Jun 2012. It was initially distributed
in Dec 2012 ex-U.S. markets.
The company is investigating the matter. Alexion believes the
voluntary recall will not impact the supply of Soliris. Though
current supplies of Soliris may not be interrupted, we believe
further slipups regarding Soliris will impact the drug's
supplies. This will be catastrophic for the company since it is
entirely dependent on Soliris for growth.
We note that this is not the first setback for Alexion regarding
Soliris this year. In March the U.S. Food and Drug Administration
issued a warning letter to Alexion as the company did not comply
with the current Good Manufacturing Practices (cGMP) at its
manufacturing facility at Rhode Island. Alexion manufactures
Soliris at the facility.
Alexion, a biopharmaceutical company, presently carries a Zacks
Rank #2 (Buy). Other well-placed stocks in the biopharma space
Gilead Sciences Inc.
Anthera Pharmaceuticals, Inc.
). While Actelion and Gilead carry a Zacks Rank #1 (Strong Buy),
Anthera carries a Zacks Rank #2.