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FDA Rejects Endo Health Solutions Inc. (Formerly Known as Endo Pharmaceuticals Holdings Inc.) (ENDP) Petition to Protect Its Painkiller Franchise



5/13/2013 8:23:48 AM

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Endo Health Solutions Responds to FDA's Denial of OPANA® ER Citizen Petition and the Potential Approval of Additional Non-Abuse Deterrent Formulations of Generic Oxymorphone

MALVERN, Pa.
, May 10, 2013 /PRNewswire/ -- Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that the U.S. Food and Drug Administration (FDA) has denied a Citizen Petition filed by its subsidiary, Endo Pharmaceuticals Inc. Endo presented FDA data collected from an ongoing epidemiology study that indicate that per 100,000 prescriptions dispensed, the past 30-day abuse rate of crush-resistant OPANA ER was 79 percent lower than the abuse rate of generic versions of extended-release oxymorphone that were on the market in 2012. Endo, through its Citizen Petition, requested that FDA:

  • Determine that the original, non-abuse deterrent formulation of OPANA ER was withdrawn from sale for reasons of safety, as is supported, in part, by the ongoing epidemiology studies
  • Refuse to approve any abbreviated new drug applications that referenced the non-abuse deterrent version of OPANA ER
  • Suspend the approvals of generic formulations of OPANA ER currently on the market.

The FDA decided that the original formulation of OPANA ER was not withdrawn from the market for reasons of safety or effectiveness. As a result, generic versions of the original formulation can continue to be approved and marketed. Additionally, FDA issued a complete response to Endo's supplemental new drug application requesting the addition of labeling language describing the abuse-deterrent properties of OPANA ER.

"We are extremely disappointed and disagree with today's decision, and believe that the approval of non-abuse deterrent formulations of long acting opioids will contribute to a significant increase in prescription drug abuse," said Rajiv De Silva, president and chief executive officer of Endo Health Solutions. "With the approval and expected launch of additional non-abuse deterrent generic versions of OPANA ER, we will carefully assess Endo's position in the competitive landscape and explore all options, including those intended to mitigate the effect of this decision. Endo remains committed to patient safety, including appropriate use of our products, as a top priority."

Endo's financial guidance for 2013 included an assumption that FDA would remove generic versions of OPANA ER from the market by mid-year. In isolation, Endo estimates that the denial of the Citizen's Petition and the potential launch of multiple generic formulations of non-abuse deterrent oxymorphone could reduce 2013 total net sales of OPANA ER by up to $120 million and reduce adjusted diluted EPS by up to approximately $0.55 in 2013. However, the company is actively pursuing cost-reduction actions that will reduce the earnings effect of FDA's decision. Endo will provide an update to its 2013 guidance on or before the second quarter financial results conference call in August.

About OPANA ER
OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. WARNING: ABUSE POTENTIAL, LIFETHREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL

Abuse Potential
OPANA ER contains oxymorphone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient's risk for opioid abuse or addiction prior to prescribing OPANA ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving OPANA ER for signs of misuse, abuse, and addiction during treatment.

Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of OPANA ER, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential and OPANA ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OPANA ER or following a dose increase. Instruct patients to swallow OPANA ER tablets whole. Crushing, dissolving, or chewing OPANA ER can cause rapid release and absorption of a potentially fatal dose of oxymorphone.

Accidental Exposure
Accidental ingestion of OPANA ER, especially in children, can result in a fatal overdose of oxymorphone.

Interaction with Alcohol
The coingestion of alcohol with OPANA ER may result in an increase of plasma levels and potentially fatal overdose of oxymorphone. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on OPANA ER.

About Endo

Endo Health Solutions Inc. (Endo) is a U.S.-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Through our operating companies: AMS, Endo Pharmaceuticals, HealthTronics and Qualitest, Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates value for patients, providers and payers alike. Learn more at www.endo.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

SOURCE Endo Health Solutions Inc.



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