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Endo Provides Update On Opana ER

DUBLIN, July 6, 2017 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse. Nevertheless, after careful consideration and consultation with the FDA following the FDA's June 2017 withdrawal request, the Company has decided to voluntarily remove Opana ER from the market. As a result, the Company expects to incur a pre-tax impairment charge of approximately $20 million in the second quarter of 2017 to write-off the remaining net book value of its Opana ER intangible asset. Reported net sales of Opana ER were $158.9 million for full-year 2016 and $35.7 million for first quarter 2017.

Endo plans to work with FDA to coordinate the orderly removal of Opana ER in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals. Patients taking Opana ER should discuss treatment options with their prescribing physician at their next visit.

Endo reiterates that neither the FDA's withdrawal request nor Endo's decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed. To the contrary, Endo remains confident in the clinical research and other data demonstrating Opana ER's safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.

About Endo International plc

Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements," including, but not limited to, statements regarding Endo's voluntary withdrawal of OPANA® ER, Endo's intent to coordinate with the FDA, the manner in which OPANA® ER will be withdrawn and the potential impact of such withdrawal on the patients, the market and Endo's business and expected, estimated or anticipated future results. Because forecasts are inherently estimates that cannot be made with precision, Endo's performance may differ materially from its expectations, estimates and targets, and Endo often does not know what the actual results will be until after the end of the applicable reporting period. Therefore, Endo will not report or comment on its progress during a current quarter except through public announcement. Any statement made by others with respect to progress during a current quarter cannot be attributed to Endo. All forward-looking statements in this press release reflect Endo's current analysis of information and represent Endo's judgment only as of the date of this press release. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Endo's expectations. Risks and uncertainties include, among other things, general industry and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes, including regulatory decisions and other unusual items; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; the outcome of litigation, settlement discussions or other adverse proceedings; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.

Source: Endo International plc

Posted: July 2017


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