Endo says Opana ER supply disruption will be temporary
pharmafile | February 28, 2012 | News story | Manufacturing and Production |Â Â Endo, Novartis, Opana ERÂ
Endo Pharmaceuticals has said that current supply restrictions for its new Opana ER formulation of oxymorphone are likely to be short-lived as it brings additional manufacturing capacity is brought online.
Endo first said it was experiencing supply constraints for Opana ER in January, after its manufacturing partner Novartis closed down a production line at its facility in Lincoln, Nebraska, that had been affected by GMP compliance issues.
Specifically, Endo said that there were “rare instances of errors in the packaging of the tablets, potentially resulting in product mix-ups,” affecting Opana ER, earlier formulation Opana and various other painkiller products.
Since then, manufacturing activities at the Lincoln plant have been resumed, allowing Endo to meet the remaining allocation for manufacturing the active ingredient awarded by the US Drug Enforcement Agency (DEA).
Opana ER is a major growth product for Endo, with sales in the fourth quarter of 2011 advancing 46% thanks in part to the approval in December of a new crush-resistant formulation designed to make the product less liable for abuse. Overall, Endo reported pharmaceutical sales of $2.7 billion in 2011.
The new formulation also provides additional patent protection on the franchise until November 2023, which is important for Endo as the first generic competitors to the original Opana ER formulation started to appear last year.
Endo’s chief financial officer Julie McHugh said that this new formulation would also help it ease some of the supply constraints, as the company is accelerating production of the crush-resistant version in partnership with Grunenthal and the latter’s contract manufacturing organisation PMRS Inc.
Manufacturing of the new formulation is expected to be at commercial scale early in the second quarter of this year, said McHugh, adding that by the end of March, the company expects to have depleted all of the old formulation of Opana ER in the marketplace and only be shipping the new crush-resistant formulation.
Meanwhile, the shutdown of Novartis’ Nebraska also had an impact on availability of Endo’s Voltaren gel (diclofenac) product – another big earner for the company – and McHugh said the company was now working with Novartis to try to transfer production to another facility.
“We expect resupply to begin during the early second quarter and to be able to reach commercial scale by the end of the second quarter,” she said.
Phil Taylor
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