Endo Sees Drug Shortages Because of Novartis Plant
By Elizabeth Lopatto and Molly Peterson
(Updates share price in the final paragraph.)
Jan. 9 (Bloomberg) — Endo Pharmaceuticals Holdings Inc., maker of the Opana ER painkiller, said there will be shortages of the drug while the plant that makes it is closed for improvements.
Some other analgesics produced there may also experience supply disruptions, Chadds Ford, Pennsylvania-based Endo said in a statement today. Novartis AG operates the factory, and the halt is meant to lower the chances of product packaging mix-ups.
Opana ER is a crush-resistant version of the narcotic pain medicine, which was approved by the Food and Drug Administration in December. The new formula is expected to have $450 million in sales, or 14 percent of Endo’s revenue, in 2012, according to the average estimate of 10 analysts surveyed by Bloomberg.
The packaging issues “could result in an incorrect pill of one medicine ending up in the bottle of another product Fake Watches,” Edward Cox, director of the FDA’s Office of Antiviral Products, said today on a conference call with reporters. “The likelihood of finding a wrong pill in an opioid pain medicine is low and patients should not be alarmed.”
The FDA hasn’t received any reports of adverse events related to a mix-up, Cox said. Patients should check their pain medicine and take it to their pharmacy if they find any tablet of a different size, shape or color from their regular pills, he said.
Other products affected include Opana, Percocet, Percodan, Endocet, Endodan, morphine tablets and Zydone. In order to alleviate shortages, Endo has begun making Percocet and Endocet at its Huntsville, Alabama, plant.
Novartis Plant
Novartis Chief Executive Officer Joseph Jimenez said the drugmaker is in discussions with the FDA about restarting production at its Lincoln Replica watches, Nebraska, plant. Novartis temporarily suspended operations at the facility after consumer complaints about broken pills and packaging mix-ups, the Basel, Switzerland-based company said Jan. 8.
While Jimenez declined to comment on when the plant may reopen, he said analyst reports that the plant could be closed for a year were a “big surprise” to him. He spoke at the J.P. Morgan Healthcare Conference in San Francisco.
Endo gained less than 1 percent to $33.86 at the close in New York.
–With assistance from Albertina Torsoli in San Francisco. Editors: Angela Zimm, Andrew Pollack
To contact the reporter on this story: Elizabeth Lopatto in New York at elopatto@bloomberg.net.
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
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