AMAG Pharmaceuticals Announces Issuance of New U.S. Patent for Ferumoxytol
WALTHAM, Mass., Jan. 31, 2014 (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. 8,591,864, Polyol and Polyether Iron Oxide Complexes as
Pharmacological and/or MRI Contrast Agents, expiring in March 2020. This
patent is directed to compositions that include the chemical structure and to
500 mg to 600 mg unit doses of ferumoxytol. This patent is listed in Approved
Drug Products with Therapeutic Equivalence Evaluations (commonly known as the
Orange Book), published by the United States Food and Drug Administration.
"We are pleased to announce this new patent for ferumoxytol that is especially
important for the long-term value of a product that generated 28 percent
revenue growth last year in the United States," commented Frank Thomas, chief
operating officer of AMAG.
AMAG now has five Orange Book-listed patents for ferumoxytol, with patent
protection through March 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
intends 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
About Feraheme® (ferumoxytol)/Rienso
In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV)
use is indicated for the treatment of iron deficiency anemia (IDA) in adult
patients who have failed oral iron therapy. Feraheme received marketing
approval from the FDA on June 30, 2009 for the treatment of IDA in adult
chronic kidney disease (CKD) patients and was commercially launched by AMAG in
the U.S. shortly thereafter.
Ferumoxytol is protected in the U.S. by five issued patents covering the
composition and dosage form of the product. Each issued patent is listed in
the FDA's Orange Book. These patents are set to expire in March 2020; a
request for patent term extension has been filed, which, if granted, may
extend the patent term to June 2023 for one of the patents.
Ferumoxytol received marketing approval in Canada in December 2011, where it
is marketed by Takeda as Feraheme, and in the European Union in June 2012 and
Switzerland in August 2012, where it is marketed by Takeda as Rienso.
For additional U.S. product information, including full prescribing
information, please visit www.feraheme.com.
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
company's patents, patent term extension and intellectual property protection,
are forward-looking statements which involve risks and uncertainties that
could cause actual results to differ materially from those discussed in such
Such risks and uncertainties include: (1) uncertainties regarding the
likelihood and timing of potential approval of AMAG's supplemental New Drug
Application (sNDA) for Feraheme in the U.S. in the broader iron deficiency
anemia (IDA) indication, (2) the possibility that following the FDA's review
of post-marketing safety data, including reports of serious anaphylaxis,
cardiovascular events, and death, the FDA will request additional technical or
scientific information, new studies or reanalysis of existing data, on-label
warnings, post-marketing requirements/commitments or risk evaluation and
mitigation strategies (REMS) in the current CKD indication for Feraheme, (3)
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, as a result of limitations, restrictions or warnings in
Feraheme's/Rienso's current or future label that put Feraheme/Rienso at a
competitive disadvantage, (4) uncertainties regarding Takeda's ability to
obtain regulatory approval for Feraheme in Canada, and Rienso in the EU, in
the broader IDA patient population, (5) the possibility that significant
safety or drug interaction problems could arise with respect to
Feraheme/Rienso and in turn affect sales, or the company's ability to market
the product both in the US and outside of the US, including the EU, (6)
uncertainties regarding the manufacture of Feraheme/Rienso, (7) uncertainties
relating to our patents and proprietary rights, both in the US and outside of
the US, (8) the risk of an Abbreviated New Drug Application (ANDA) filing
following the FDA's recently published draft bioequivalence recommendation for
ferumoxytol, and (9) other risks identified in our Securities and Exchange
Commission filings, including our Quarterly Report on Form 10-Q for the three
months ended September 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
Pharmaceuticals, Inc.MuGard® is a registered trademark of Access
Rienso is a trademark of Takeda Pharmaceutical Company Limited.
CONTACT: AMAG Pharmaceuticals, Inc. Contact:
Amy Sullivan, 617-498-3303
AMAG Pharmaceuticals logo
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