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AMAG Defends Feraheme Safety: BioBuzz

AMAG Pharmaceuticals used a Friday evening conference call to swat down safety concerns about its intravenous iron replacement therapy Feraheme.



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Shares of AMAG Pharmaceuticals

(AMAG) - Get AMAG Pharmaceuticals, Inc. Report

will attempt a Monday morning rally after the company used a Friday evening conference call to swat down

safety concerns

about its intravenous iron replacement therapy Feraheme.

Since the commercial launch of Feraheme last July, 40 serious adverse events have been reported in 35,000 "patient exposures" -- a serious adverse event rate of 0.1%, according to AMAG.

That's well within what was expected from Feraheme, according to the drug's safety performance in clinical trials, the company added.

One patient died two days after treatment with Feraheme, which the company insists was not related to Feraheme.

Feraheme is an intravenous form of iron used to treat anemia in patients with chronic kidney disease.

AMAG shares fell 16% Thursday to $38.12 and were down as much as 10% to $34.06 during Friday's trading session after SummerStreet Research Partners downgraded AMAG shares to neutral from buy, citing information that patients treated with Feraheme were suffering from severe allergic reactions.

AMAG spent much of Thursday on the phone with analysts and investors defending Feraheme's safety record, but with the stock continuing to fall Friday amidst a broader market selloff, the company decided to issue a public statement and hold a conference call Friday evening.

"This is a very unusual step for us, to respond to market concerns in this manner, but we felt that these circumstances were sufficiently exceptional to warrant our response. We do not intend to respond to similar circumstances in this manner going forward, nor do we intend to provide periodic updates," said AMAG CEO Brian Pereira, on the call.

In clinical trials, hypersensitivity or severe allergic reactions to Feraheme were reported in 0.2%, or three patients out of 1,726 patients treated, according to the drug's label approved by the U.S. Food and Drug Administration.

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The mortality rate was 1.1% among ferumoxytol-treated subjects compared with 2.8% among subjects treated with whole iron. None of these deaths were considered related to study treatment, the company said.

"Late Friday's announcement of the Feraheme safety findings from the commercial setting supported the view that its safety profile is intact and that the anecdotal findings of serious adverse events should not be a significant hindrance to its commercial uptake," wrote J.P. Morgan biotech analyst Matt Roden in a note to clients Monday. Roden maintained his outperform rating on AMAG shares.

SummerStreet Research Partners analyst Carol Werther, who triggered the selloff in AMAG shares with her note Thursday, told


Friday that she, too, thought the selloff was "overdone," but she was not ready to call Feraheme completely safe.

"The clinicians I spoke to are going to use the drug more cautiously until they have more information. Whether the information that came out today is enough, I have no idea," she told



AMAG shares rallied into end of Friday's trading session, closing at $37.77. The stock hit $39.50 in Friday's after-hours trading session.

-- Reported by Adam Feuerstein in Boston.

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