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Endo Announces Potential Short-Term Supply Constraints of Certain Analgesic Medications as a Result of Temporary Shut Down of Novartis Facility
Date:1/9/2012

CHADDS FORD, Pa., Jan. 9, 2012 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today announced that, as a result of a temporary shut-down of Novartis Consumer Health Inc.'s Lincoln, Neb., manufacturing facility, there will be a short-term supply constraint of OPANA® ER.  The company also announced certain other Endo analgesic products manufactured at this facility may experience short-term supply disruptions.  Endo is working closely with the U.S. Food and Drug Administration (FDA) and Novartis to minimize patient disruptions and promptly resume production of Endo's products at the Lincoln facility.

The suspension of production at the Lincoln, Neb. facility was done to facilitate Novartis's implementation of certain manufacturing process improvements.  These improvements are intended to address the possibility of rare instances of errors in the packaging of the tablets, potentially resulting in product mix-ups.  The temporary supply disruption is not related to the efficacy or safety of Endo's products.

"We are working collaboratively with the FDA to minimize the disruption to patients currently on therapy.  Given existing inventories, the expected restart of Novartis production and our ability to shift production to other facilities we believe the supply constraints of our products should be limited,"  said Julie McHugh, chief operating officer of Endo Pharmaceuticals.  "With Novartis as the sole manufacturer of the current formulation of Opana ER, we plan to temporarily moderate demand of the product by asking physicians to refrain from starting new patients on Opana ER in order to minimize disruption for patients currently on the product.  We currently expect this to be a short-term issue and we remain focused on working with the healthcare community to optimize the continued supply of our product
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SOURCE Endo Pharmaceuticals
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