NEW YORK, Jan. 12, 2015 /PRNewswire/ -- Attorney
Advertising-- Bronstein, Gewirtz & Grossman, LLC is
investigating potential claims on behalf of purchasers of the
securities of AMAG Pharmaceuticals, Inc. ("AMAG" or the "Company")
(NasdaqGS: AMAG -News). Such investors are advised to contact
Peretz Bronstein or his investor
relations coordinator Eitan Kimelman
at info@bgandg.com or 212-697-6484.
The investigation concerns whether AMAG and certain of its
officers and/or directors have violated Sections 10(b) and 20(a) of
the Securities Exchange Act of 1934.
On May 22, 2013 the company
announced in regulatory filing that it has been made aware by
Takeda Pharmaceutical Company Limited, the exclusive product
distributor of ferumoxytol in Switzerland, that it is recalling one specific
batch of Rienso, ferumoxytol, from the Swiss market. This decision
is based on a cluster of four post-marketing adverse event reports
in Switzerland concerning
hypersensitivity reactions of varying severity following the
administration of Rienso from this batch.
Then on September 25, 2013, the
Company disclosed in a regulatory filing that it had received a
notification from the FDA in connection with the Company's
supplemental New Drug Application for its Feraheme Injection on
September 23, 2013. The FDA
stated, "that, as part of its ongoing review of the Company's sNDA,
the FDA has identified deficiencies that preclude discussion of
labeling and postmarketing requirements/commitments by September 23, 2013, a target date previously
communicated by the FDA in a letter dated March 5, 2013."
On January 7, 2014, the Company
had a discussion with the FDA regarding the status of the review of
the sNDA. The FDA indicated that the sNDA is under active review;
however, the FDA has not yet entered into discussions with the
Company regarding proposed labeling or postmarketing
requirement/commitment requests for the broader indication for
Feraheme.
Then on January 22, 2014, the
Company announced that the FDA has issued a complete response
letter for the supplemental new drug application for Feraheme
(ferumoxytol) injection for intravenous use. The sNDA sought to
expand the indication for Feraheme beyond the current chronic
kidney disease indication to include all adult iron deficiency
anemia (IDA) patients who have failed or cannot tolerate oral iron
treatment. In the letter, the FDA stated that AMAG has not
provided sufficient information to permit labeling of Feraheme for
safe and effective use for the proposed indication. The FDA
indicated that its decision was based on the cumulative ferumoxytol
data, including the global phase III IDA program and global
post-marketing safety reports. The FDA suggested that AMAG generate
additional clinical trial data in the proposed broad IDA patient
population with a primary composite safety endpoint of serious
hypersensitivity/anaphylaxis, cardiovascular events, and death.
On this news, shares of AMAG fell $1.68 per share to more than 7.69% on intraday
trading to a price of $20.18 on
January 22, 2014.
On January 9, 2015 the Company
announced that, "on June 2, 2014,
AMAG Pharmaceuticals, Inc. (the "Company") proposed to the U.S.
Food and Drug Administration ("FDA") changes to the current U.S.
label of Feraheme (ferumoxytol) Injection based on a review of
global post-marketing data. The intended purpose of the label
changes in the U.S. was to strengthen the warnings and precautions
section of the label and mitigate the risk of serious
hypersensitivity reactions, including anaphylaxis, in order to
enhance patient safety. The proposed changes were subject to review
and approval by the FDA.
After considering the Company's June
2014 submission and other information, on January 7, 2015, the FDA notified the Company
that it believes new safety information should be included in the
labeling for Feraheme, including, among other things, a boxed
warning to highlight the risks of serious
hypersensitivity/anaphylaxis reactions and revisions that Feraheme
should only be administered through an intravenous ("IV") infusion
(i.e., not by IV injection) and should be contraindicated for
patients with any known history of drug allergy. The FDA's
recommended label changes go beyond what the Company proposed in
June 2014."
On this news, shares of AMAG fell $3.54 per share or 7.70%, to close at
$42.44 on January 9, 2015.
If you are aware of any facts relating to this investigation, or
purchased shares of AMAG, you can assist this investigation by
contacting Peretz Bronstein or his
Investor Relations Coordinator Eitan
Kimelman of Bronstein, Gewirtz & Grossman, LLC at
212-697-6484 or via email info@bgandg.com. Those who inquire
by e-mail are encouraged to include their mailing address, email
and telephone number.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation
boutique. Our primary expertise is the aggressive pursuit of
litigation claims on behalf of our clients. In addition to
representing institutions and other investor plaintiffs in class
action security litigation, the firm's expertise includes general
corporate and commercial litigation, as well as securities
arbitration. Attorney advertising. Prior results do not
guarantee similar outcomes.
Contact:
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Eitan Kimelman 212-697-6484
info@bgandg.com
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SOURCE Bronstein, Gewirtz & Grossman, LLC