AMAG's Feraheme Gets Canada Nod - Analyst Blog
15 Décembre 2011 - 4:00PM
Zacks
After a long time AMAG Pharmaceuticals Inc.
(AMAG) got a chance to announce some good news. AMAG and partner
Takeda stated that Health Canada has approved its sole marketed
drug Feraheme as an intravenous (IV) iron replacement therapeutic
for the treatment of iron deficiency anemia (IDA) in chronic kidney
disease (CKD) patients. AMAG is entitled to receive a milestone
payment of $3 million from Takeda upon first commercial sale in
Canada.
Feraheme is already marketed in the US for the disease and is
under review in the European Union (EU) where it is expected to be
cleared in the first quarter of next year. The drug’s sales have
been struggling as changes in dialysis reimbursement have
negatively impacted reimbursement for high priced drugs like
Feraheme.
Separately, AMAG recently presented preliminary data from a
trial which evaluated the safety and efficacy of a single infusion
of 1020 mg of Feraheme in patients with IDA at the American Society
of Hematology meeting (ASH). The Feraheme label currently allows
two sequential 510mg infusions 3 to 8 days apart. The data
demonstrated the efficacy of the 1020 mg infusion and highlighted
that a single infusion of Feraheme did not cause any serious
adverse event. However, around 44% of the 36 patients experienced
minor adverse events.
As a reminder, in late October 2011, AMAG announced the
termination of its deal to merge with Colorado based Allos
Therapeutics, Inc. (ALTH). AMAG had
entered into an agreement to merge with Allos in July this year in
an all stock deal that had a total equity value of $686 million.
The deal failed to receive sufficient shareholder votes necessary
for closure. AMAG management thus decided to restructure its
expenses, including a workforce reduction of 25% to bring it in
line with expected sales from Feraheme.
AMAG is also conducting a large global registrational program to
expand the label for Feraheme for IDA treatment irrespective of the
underlying cause. If Feraheme gets approval for the broad label it
would boost sales significantly. Moreover, AMAG hopes to generate
$60 million in revenue from Feraheme in 2012, representing low
double-digit growth.
AMAG thus hopes to turn profitable in 2013 from a combination of
expense reduction policies, completion of the IDA program,
potential Feraheme revenue in Canada and EU and moderating revenue
growth in US.
We note that AMAG management is evaluating all strategic
alternatives for the company, including a potential sale, merger,
acquisition, or in-licensing opportunity and has hired
Jefferies & Company, Inc. (JEF) as a financial
advisor to help it evaluate these strategic alternatives.
Our Recommendation
We currently have an Outperform recommendation on the stock. The
stock carries a Zacks #2 Rank (short term “Buy” rating). We are
optimistic about the company’s new restructuring plan and its
efforts to explore strategic initiatives, which we believe will
bring it on track after the failed Allos deal.
ALLOS THERAPEUT (ALTH): Free Stock Analysis Report
AMAG PHARMA INC (AMAG): Free Stock Analysis Report
JEFFERIES GP-NW (JEF): Free Stock Analysis Report
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