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LONDON, May 27 (Reuters) - AstraZeneca said onFriday U.S. regulators would not approve its new drug for highpotassium levels at present due to a manufacturing issue,dealing a blow to a product acquired when it bought ZS Pharmafor $2.7 billion last year.
Analysts said the drug's launch would now likely be delayeduntil 2017 after the British drugmaker said the Food and DrugAdministration (FDA) had issued a so-called complete responseletter (CRL) for ZS-9, or sodium zirconium cyclosilicate.
Such letters typically outline concerns and conditions thatmust be addressed to gain U.S. approval.
"The CRL refers to observations arising from a pre-approvalmanufacturing inspection," AstraZeneca said.
"The FDA also acknowledged receipt of recently submitteddata which it has yet to review. The CRL does not require thegeneration of new clinical data."
A spokesman said the company hoped to resolve the matter ina "timely" manner.
Berenberg analysts said AstraZeneca would probably face asix-month review once it refiled with the FDA. "Assuming thecompany can refile in a matter of months, an approval in Q1 2017could be possible," they wrote in a note.
The setback offset positive news from a clinical trialtesting Faslodex in breast cancer, which may boost sales of thatmedicine.
Buying ZS Pharma was one of several bolt-on acquisitions byAstraZeneca designed to help build up its pipeline of new drugs.
ZS-9 treats hyperkalaemia, or high potassium levels, whichis typically associated with chronic kidney disease and chronicheart failure. AstraZeneca said when the acquisition wasannounced in November that its peak sales were forecast toexceed $1 billion. (Reporting by Ben Hirschler; Editing by Alexander Smith)
