FDAnews Drug Daily Bulletin

Alexion Faces Potential $25 Million Charge From Soliris Recall

Nov. 14, 2013

Alexion’s recall and replacement of vials of its rare disease drug Soliris could cost the company between $10 and $25 million in the fourth quarter, the drugmaker says in a Tuesday SEC filing.

The recall and replacement was prompted by the presence of visible particles observed as part of Alexion’s periodic testing of retained samples. “Post-release testing from the two affected lots met quality specifications prior to the recent observations,” the filing states. “There have been no identifiable safety concerns attributed to the product consumed from these lots to date,” it adds.

The biotech declined to state the exact number of vials affected by the market correction, but said they represent less than one percent of its total inventory.

The move follows an August recall and replacement of a single lot of Soliris (eculizumab) due to the presence of similar visible particles. The lot recalled in August, and the two current affected lots, were filled by the same contract vialer, Alexion says. Upon further investigation, Alexion now believes it has identified the filling process step that resulted in the presence of particles. The company has since implemented the change necessary to correct the issue, the filing states.

Alexion has engaged an additional contract vialer for Soliris, using the corrected process step, which is expected to be approved in 2014.

Requests to Alexion for further details about the process step and the volume of vials recalled were not returned by press time Wednesday. — Johnathan Rickman

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