UPDATE 2-AMAG anemia drug wins US approval, shares jump

[okarol]

UPDATE 2-AMAG anemia drug wins US approval, shares jump
Tue Jun 30, 2009 11:13pm EDT


 * FDA approves drug for iron deficiency anemia

 * Company says drug's convenience could widen treatment

 * Shares rise 5 pct after hours
 (Adds CEO quotes, background on anemia drug, bylines)

 By Ransdell Pierson and Bill Berkrot

 NEW YORK, June 30 (Reuters) - AMAG Pharmaceuticals Inc
(AMAG.O) said U.S. regulators approved its injectable anemia
medicine Feraheme, which will be available to patients by the
second half of July, lifting shares of the tiny company by 5
percent.

 AMAG said Tuesday the U.S. Food and Drug Administration had
approved the drug as an iron replacement therapy in adults with
iron deficiency anemia that have chronic kidney disease.

 The company said Feraheme, which needs to be given less
frequently than existing iron replacement drugs, could widen
treatment to far more patients and likely achieve blockbuster
sales.

 "Feraheme offers patients across the continuum of chronic
kidney disease, including patients not on dialysis and patients
on dialysis, a new paradigm for the treatment of iron
deficiency anemia," the company said in a statement.

 "It would be a shame if this drug didn't reach a billion
dollar (annual sales) potential in fairly short order because
there are tens of millions of patients worldwide who have iron
deficiency anemia and this offers an attractive treatment
option and literally a cure," Chief Executive Brian Pereira
said in an interview after learning of the FDA approval.

 "We think this will change patients' lives," Pereira said,
who added that the FDA did not impose any unexpected
restrictions or requirements on usage of the drug.

 "We are delighted. It's rare in life that you can say you
got everything you hoped for, and we did," he said.

 The FDA approved Feraheme based on favorable safety and
efficacy data from four late-stage studies of patients with
chronic kidney disease and iron deficiency anemia. The drug
significantly boosted hemoglobin levels, compared with oral
iron replacement drugs, AMAG said.

 The Lexington, Massachusetts-based company said it plans to
begin two small trials next year of Feraheme among pediatric
patients with chronic kidney disease. One will be in patients
on dialysis, a blood-cleaning procedure needed by patients with
advanced kidney disease, and the other in patients not on
dialysis.

 In an interview earlier this month, Pereira described
Feraheme as a simple drug that has immense convenience
advantages over current iron therapy. Patients who now require
about 10 lengthy infusion sessions to boost iron levels could
be treated with Feraheme with two injections that take just 17
seconds to administer, he said.

 Feraheme has a special sugar coating to protect blood
vessels, Pereira said.

 Many anemic kidney patients now receive Amgen Inc's
(AMGN.O) Epogen or Johnson & Johnson's (JNJ.N) Procrit, red
blood cell boosters that have come under intense scrutiny over
safety and overuse concerns. Pereira said Feraheme could help
to significantly reduce the needed dosages of those drugs.

 Relatively few kidney patients not yet on dialysis are
taking iron therapy for their anemia despite fatigue and other
effects of the condition due to the extreme inconvenience of
infusions, a market Feraheme could break open, Pereira said.

 Company shares were up 5 percent at $57.11 in after hours
trading from their Nasdaq close of $54.67.
 (Reporting by Ransdell Pierson and Bill Berkrot, editing by
Matthew Lewis and Tim Dobbyn)

http://www.reuters.com/article/governmentFilingsNews/idUSN3047044520090630