Endo Announces Potential Short-Term Supply Constraints of Certain Analgesic Medications as a Result of Temporary Shut Down of Novartis Facility
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 products for current patients."
As a result of the Novartis facility shutdown, Endo will be expediting the production of products at alternative manufacturing facilities. Endo has initiated the manufacturing of PERCOCET® and ENDOCET® at its Huntsville, Ala., facility and expects minimal disruption to patients on these products. Separately, Endo also has plans to put additional procedures in place to assist Novartis in restarting production at the Lincoln, Neb., manufacturing facility. In addition to the short-term supply constraint of Opana ER, the Endo medicines that may experience a short-term supply disruption include the following products manufactured at the Lincoln facility:
OPANA® (oxymorphone hydrochloride) Tablets CII
Oxymorphone Hydrochloride Tablets CII
PERCOCET® (oxycodone hydrochloride and acetaminophen USP)
Tablets CII
PERCODAN® (oxycodone hydrochloride and aspirin, USP) Tablets
CII
ENDOCET® (oxycodone hydrochloride and acetaminophen USP)
Tablets CII
ENDODAN® (oxycodone hydrochloride and aspirin, USP) Tablets
CII
Morphine Sulfate Extended-Release Tablets CII
ZYDONE® (hydrocodone bitartrate/acetaminophen tablets, USP)
CIII
Endo filed a Form 8-K with the U.S. Securities and Exchange Commission today to provide additional detail regarding the current situation at the Novartis manufacturing facility.
About Endo
Endo Pharmaceuticals is a U.S.-based, specialty healthcare
solutions company with a diversified business model, operating in
three key business segments – branded pharmaceuticals,
generics and devices and services. We deliver an innovative suite
of complementary products and services to meet the needs of
patients in areas such as pain management, pelvic health, urology,
endocrinology and oncology. For more information about Endo
Pharmaceuticals, and its wholly owned subsidiaries American Medical
Systems and Qualitest Pharmaceuticals, as well as its affiliate
HealthTronics, Inc., please visit http://www.endo.com/.
Safe Harbor Statement
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otherwise enumerated herein or therein, could affect our future
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SOURCE Endo Pharmaceuticals
Media, Kevin Wiggins, +1-610-459-7281, or Investors/Media,
Blaine Davis, +1-610-459-7158, or Investors, Jonathan Neely,
+1-610-459-6645
"Safe Harbor" Statement under the Private Securities Litigation
Reform Act of 1995: Statements in this press release regarding Endo
Pharmaceuticals business which are not historical facts are
"forward-looking statements" that involve risks and uncertainties.
For a discussion of such risks and uncertainties, which could cause
actual results to differ from those contained in the
forward-looking statements, see "Risk Factors" in the Company's
Annual Report or Form 10-K for the most recently ended fiscal
year.
Posted: January 2012
