Alexion Pharmaceuticals, Inc.
) provided additional information on its voluntary recall of two
lots of the company's sole marketed product Soliris. Alexion
stated that this voluntary move was prompted by the presence of
visible particles in vials in the two lots of the drug. Alexion
believes these have the potential to affect the safety of
patients in two broad areas: immunogenicity and thromboembolic
Alexion said that it has issued instructions to hospitals as well
as users to return unused vials of Soliris from both the affected
lots . Last month, Alexion had given similar instructions but
they were limited to the distributor level.
Soliris is available for the treatment of paroxysmal nocturnal
hemoglobinuria and atypical hemolytic uremic syndrome (aHUS).
Japanese approval for Soliris in the aHUS indication came in Sep
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 (FDA) 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. An FDA
re-inspection is scheduled in the first half of 2014. We believe
that any slip on the company's part to comply with the FDA's
quality control requirements will invite strict action from the
agency. Such an action will affect the supplies of Soliris.
Alexion, a biopharmaceutical company, carries a Zacks Rank #3
(Hold). Some better-ranked stocks in the biopharma space include
Vanda Pharmaceuticals Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).
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