In a filing with the Securities and Exchange Commission (SEC), Alexion Pharmaceuticals, Inc. (ALXN) 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 uremic syndrome.
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 include Actelion Ltd. (ALIOF), Gilead Sciences Inc. (GILD) and Anthera Pharmaceuticals, Inc. (ANTH). While Actelion and Gilead carry a Zacks Rank #1 (Strong Buy), Anthera carries a Zacks Rank #2.
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