Endo

Endo to restructure manufacturing network

Monday, July 24, 2017

Endo International announced that after completing a comprehensive review of its manufacturing network, the company will be ceasing operations and closing its manufacturing and distribution facilities in Huntsville, Alabama. The closure of the facilities is expected to take place over the next 12 to 18 months. The Huntsville location has been impacted by declining volumes of commoditized products and these restructuring actions are intended to better match manufacturing capacity to projected future demand.

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Endo Pharmaceuticals to remove OPANA from the market

Friday, July 7, 2017

Endo International plc 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.

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FDA requests removal of Opana ER for risks related to abuse

Monday, June 12, 2017

The FDA requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

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Endo restructures, cuts 90 jobs

Friday, January 27, 2017

Endo International announced that as part of its comprehensive organizational review, it has initiated a restructuring program. These restructuring actions primarily relate to the company’s corporate functions and branded pharmaceutical R&D functions in Malvern, PA, and Chestnut Ridge, NY. The restructuring program will better align these parts of our organization in size and scope with the company’s recently restructured Generics and U.S Branded Pharmaceutical business units. In addition to realizing greater efficiencies, these actions are expected to provide corresponding cost savings. Endo expects to invest a portion of these cost savings in the company’s core product franchises and new product development programs for both the Branded and Generics business segments. 

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Endo drops abuse deterrent labeling for OPANA ER

Monday, August 15, 2016

Endo International has announced that, based on an August 11, 2016 discussion with the FDA, the company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for OPANA ER without prejudice to re-filing. The company plans to continue collecting and analyzing epidemiological data relating to OPANA ER. Endo’s financial projections for 2016 did not assume approval of the sNDA.

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Report: U.S. specialty pharma’s M&A focus shifts to pipelines and innovative products

Tuesday, June 14, 2016

Despite the ongoing challenges weighing on the U.S. specialty pharmaceutical sector, companies will steadily resume M&A with a more refined focus, said Moody’s Investors Service. The ratings agency said it expects acquisitive specialty companies will increase their focus on products with unmet medical need, companies with pipeline drugs and those providing geographic expansion.

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Endo bids to acquire Salix for $11 billion

Thursday, March 12, 2015

Raleigh, N.C.-based Salix Pharmaceuticals has received an unsolicited proposal from Endo International, a global specialty healthcare company headquartered in Dublin, Ireland, to acquire all outstanding shares of common stock of the company for a combination of 1.4607 shares of Endo common stock and $45 cash per share of common stock. Based on the closing stock price of Endo on March 10, 2015, the transaction is valued at $175 per Salix share. 

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