Alexion gets FDA warning but doesn't expect Soliris disruption

Alexion is facing a tough situation for a one-hit wonder. It has been issued an FDA warning letter for its manufacturing plant where it makes its only approved drug--the rare-disease, and very pricey, Soliris.

The company says it has backup manufacturing and inventory and believes it has the matter in hand, which at least one analyst agrees with. But Alexion ($ALXN) acknowledged in an 8-K filing that such matters are never certain and the situation ultimately could affect supplies. 

Soliris, a biologic that goes for up to $400,000 a year, is approved to treat a rare kidney disorder, atypical hemolytic uremic syndrome, and the blood disorder paroxysmal nocturnal hemoglobinuria. Sales were robust last year. According to the company's annual report, 2012 revenues were $1.13 billion, up a whopping 45% on increased global sales of Soliris. 

The company is also making supplies of other drugs in its pipeline at the plant. In a note to investors, Howard Liang with Leerink Swann Research said, pointed out Lonza also is manufacturing Soliris and he does not expect a "material effect" on sales or "registration of late-stage pipeline." He said, the company "had the foresight to build duplicate manufacturing capacities. By our math, the inventory on hand from the approved facilities corresponds to roughly $1.4B in Soliris sales (comparable to our estimate of $1.5B sales for Soliris in 2013)." The company says that inventory is sellable without further FDA approval. 

The warning letter has yet to make it to the FDA's website, but the company got ahead of the news by reporting to the SEC that the warning was delivered yesterday. Alexion says the agency found some repeat violations and was not satisfied with how the company investigated "bacterial contamination of certain batches." The "FDA expressed a general concern that we have not implemented a robust quality system," the company said. 

Alexion says it is still manufacturing Soliris and other products at the Rhode Island plant. In addition to Lonza and its own plant, the company expects to have a third manufacturing facility approved in the fourth quarter. 

- see the SEC filing
- here's the link to Howard Liang/Leerink Swann Research report

Related Articles:
Alexion's Soliris to Merck's Januvia, top 20 generate huge growth
Pricey Soliris performs in another rare disease
Now, every pharma wants a $440K drug like Alexion's

 

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