UPDATED: Allergan says manufacturing issue creates shortage of Avycaz


Allergan’s superbug antibiotic Avycaz raked in $22.1 million in sales during H1. But it will be slow going for the rest of 2016 because of an issue with its API maker delaying production until early next year. That API maker turns out to be GlaxoSmithKline ($GSK). 

In a drug shortage notice with the FDA, the Dublin-based drugmaker said it had a shortage of the API and that it expected to resolve the supply interruption in the first quarter of 2017. Allergan in an email today declined to comment further. 

The company did report to Bernstein analysts, telling them “Our third party API manufacturer of Avibactam is experiencing an issue. We expect to return to production and supplying the market in early 2017.” It said the financial impact was contemplated in its recent 2016 revenue forecast. The analysts in a note to investors Monday, said the situation was worth keeping an eye on.

According to the posted prescribing information, the drug is manufactured by GSK at its plant in Verona, Italy. 

In an emailed statement today, the U.K. company said, "GSK manufactures the active pharmaceutical ingredient for the medicine Avycaz. As soon as we realized there was an issue with the supply, we contacted Allergan (who markets Avycaz in the United States) and we have been in regular communication. We are working hard to resolve the issue as soon as possible."  

AstraZeneca has the rights to the drug in Europe, where it will be sold as Zavicefta but it was approved there in June. 

Allergan got Avycaz in its $28 billion acquisition of Forest Laboratories in 2014. The antibiotic, a combination of the approved cephalosporin agent ceftazidime and avibactam, was approved by the FDA in February 2015 to treat complicated infections in the abdomen in patients with limited or no alternative treatment options. Two months ago, the FDA approved a label expansion for Avycaz use for the treatment of complicated intra-abdominal infections. The drug targets so-called gram-negative bacteria.

Allergan put a sticker price of $12,000 on the infection fighter, pretty steep in the antibiotics market. Peak sales of Avycaz were initially pegged at $300 million but when early sales last year came in higher than expected, there was a suggestion that figure might get elevated by analysts. The drug brought in $22.1 million in H1 of this year with $13.7 million of that coming in the second quarter.

- here’s the FDA drug shortage listing

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