AMAG Pharmaceuticals Announces Issuance of New U.S. Patent for Ferumoxytol
LEXINGTON, Mass., Aug. 7, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc.
(Nasdaq:AMAG) today announced that the United States Patent and Trademark
Office (USPTO) has issued a new U.S. patent to AMAG for ferumoxytol, U.S.
Patent No. 8,501,158, Polyol and Polyether Iron Oxide Complexes as
Pharmacological and/or MRI Contrast Agents, expiring in 2020. This Orange Book
listed patent covers the use of 500 mg -600 mg of ferumoxytol for the
treatment of patients with iron deficiency anemia.
"We believe that this issued patent complements and expands our intellectual
property protection for ferumoxytol, providing further specific claims related
to approved dosing and formulation," commented Frank Thomas, chief operating
officer of AMAG.
AMAG now has four Orange Book listed patents for ferumoxytol, with patent
protection through 2020, without patent term extension. AMAG has applied for a
patent term extension for an Orange Book listed ferumoxytol patent, which
would lengthen that patent term through June 2023.
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that markets
Feraheme® (ferumoxytol) Injection and MuGard™ Mucoadhesive Oral Wound Rinse in
the United States. Along with driving organic growth of its products, AMAG is
working to expand its portfolio with additional commercial-stage specialty
products. The company is seeking complementary products that leverage the
company's commercial footprint and focus on hematology and oncology centers
and hospital infusion centers. For additional company information, please
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 and other federal
securities laws. Any statements contained herein which do not describe
historical facts, including but not limited to statements regarding: the
approval of the supplemental new drug application Feraheme for a broader
patient population; the intended expansion and focus of AMAG's product
portfolio; the company's intent to drive organic growth of Feraheme; the
company's plans to seek complementary commercial products to add to its
portfolio; and the term of and the company's expected timing on approval of
certain patent term extensions are forward-looking statements which involve
risks and uncertainties that could cause actual results to differ materially
from those discussed in such forward-looking statements.
Such risks and uncertainties include: (1) uncertainties regarding our and
Takeda's ability to successfully compete in the intravenous iron replacement
market both in the US and outside the US, including the EU, (2) uncertainties
regarding our ability to compete in the oral mucositis market in the US, (3)
uncertainties regarding our ability to successfully and timely complete our
clinical development programs and obtain regulatory approval for
Feraheme/Rienso in the broader IDA indication both in the US and outside of
the US, including the EU, (4) the possibility that significant safety or drug
interaction problems could arise with respect to Feraheme/Rienso, (5)
uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (6)
uncertainties relating to our patents and proprietary rights both in the US
and outside the US, (7) the risk of an Abbreviated New Drug Application (ANDA)
filing following the FDA's recently published draft bioequivalence
recommendation for ferumoxytol, and (8) other risks identified in our
Securities and Exchange Commission (SEC) filings, including our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2013 and subsequent filings
with the SEC. We caution you not to place undue reliance on any
forward-looking statements, which speak only as of the date they are made.
We disclaim any obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or circumstances
on which any such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the forward-looking
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG
Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.
MuGard is a trademark of Access Pharmaceuticals, Inc.
CONTACT: AMAG Pharmaceuticals Contact:
Amy Sullivan, 617-498-3303
Press spacebar to pause and continue. Press esc to stop.