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.

About AMAG

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 visit www.amagpharma.com.

Forward-looking Statements  

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 statements.

AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.

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

AMAG Pharmaceuticals, Inc.