Battling new issues at its West-Ward Pharmaceutical plant in Eatontown, NJ, Hikma says it will shut it down to fix it up.
Hikma in a recent quarterly update said the FDA had found "further observations" and that it made the most sense to stop production until mid-January. It did not say what the impact will be on employees.
The Jordan-based company said it would try to keep customers supplied from inventory and fill in with production at plants in the Middle East and Africa. It also stated it will "be taking further actions to restructure the business. ... We are reviewing this business and are considering all strategic options." The company gave no clue as to what those actions might entail and a spokesperson could not be reached for comment.
The FDA in February nailed West-Ward with a warning letter over manufacturing and testing issues that led to the release of lithium and digoxin tablets that failed size specifications. The FDA also said there were issues achieving the proper dissolution rate for the lithium carbonate tablets, a slow-release version often used with bipolar patients. West-Ward has changed the manufacturing process for the drug a number of times since Nov. 25, 2008, but failed to document the effects of those changes, the FDA noted in its warning letter.
The plant problems have been a drag on the company's earnings. In the quarterly report, Hikma said its generics business, which the West-Ward plant serves, would post a loss of about $15 million for the year instead of breaking even and post about $105 million in revenue. That includes about $5 million Hikma is plowing into the New Jersey plant.
Even as it deals with its own plant and compliance problems, the company also has been taking advantage of remediation issues faced by its competitors. Its injectables sales are up because of increased demand brought on by shortages created by competitors' issues. Hikma said it now expects its injectables to exceed its forecast and turn in $460 million for the year and a EBIT margin of 22%.
- here's the Hikma statement