AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) and Takeda Pharmaceutical Company Limited (TSE: 4502) today provided a regulatory and clinical update for Feraheme® (ferumoxytol) Injection for intravenous (IV) use.

On June 1, 2010, AMAG submitted a marketing authorization application (MAA) for Feraheme for the treatment of iron deficiency anemia (IDA) in chronic kidney disease patients to the European Medicines Agency (EMA). The EMA has since notified AMAG that the submission has been validated for review.

The companies are also pleased to report that the global registrational program to expand the indication of Feraheme to include the treatment of IDA regardless of the underlying cause has been initiated. The program consists of two phase III studies – one 800 patient, double-blind, placebo-controlled study and the other a 600 patient open label, active-controlled study comparing ferumoxytol to IV iron sucrose. Both trials will evaluate changes in hemoglobin levels as well as other efficacy and safety endpoints. The program is now enrolling patients; the companies expect that it will take up to 18 months to complete enrollment.

“We have thus far made great progress on our key objectives for this year,” said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. “With the MAA filing validated by the EMA and the global registrational program for Feraheme for the broader indication of the treatment of iron deficiency anemia underway, we are several steps closer to expanding the reach of Feraheme, both geographically and to new patient populations.”

Dr. Erich Brunn, Chief Executive Officer, Takeda Pharmaceuticals Europe said: “For Takeda in Europe, this represents an important first step forward in our entry into a new therapeutic area. Feraheme has the potential to provide physicians in Europe with an important new approach in the treatment of patients with iron deficiency anemia.”

About Feraheme

In the United States, Feraheme® (ferumoxytol) Injection for intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. Feraheme is under regulatory review in Canada and Europe for the treatment of chronic kidney disease patients with iron deficiency anemia.

AMAG is seeking to expand the label and geographic availability of Feraheme to treat patients with iron deficiency anemia regardless of the underlying cause by conducting additional clinical trials and by forming strategic partnerships around the world. AMAG has two partners for the development and commercialization of Feraheme outside of the U.S.: 3SBio Inc. to develop and commercialize Feraheme for CKD in China; and Takeda Pharmaceutical Company to develop and commercialize Feraheme for all therapeutic applications in five ex-U.S. regions, including Europe, Canada, Turkey, the Commonwealth of Independent States and several Asia Pacific countries. AMAG has exclusive rights to commercialize Feraheme in the U.S. and certain ex-U.S. territories.

In addition to the global iron deficiency anemia registrational program, AMAG is evaluating Feraheme in a clinical trial, the ferumoxytol compared to iron sucrose trial (FIRST), which will enroll 150 patients with chronic kidney disease and iron deficiency anemia, and has plans to initiate pediatric studies and a Feraheme retreatment study in the coming year.

Feraheme was discovered, developed and is manufactured by AMAG Pharmaceuticals, Inc. For more information about Feraheme, including full prescribing information, please visit www.feraheme.com.

About AMAG

AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. AMAG manufactures and sells two commercial products, Feraheme® (ferumoxytol) Injection for intravenous (IV) use and GastroMARK, an oral contrast agent used in magnetic resonance imaging. For additional company information, please visit www.amagpharma.com.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Important Safety Information About Feraheme

In the United States, Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.

In U.S. registrational clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when personnel and therapies are readily available for the treatment of hypersensitivity reactions. 1.9% (33/1,726) of Feraheme-treated subjects experienced hypotension. Please monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate iron and transferrin bound iron values in the 24 hours after administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.

In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in ≥ 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria. For full prescribing information, please visit www.feraheme.com.

Forward Looking Statements Related to AMAG

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 AMAG’s plans to initiate pediatric studies and a Feraheme retreatment study in the coming year and AMAG’s expectation that it will take up to 18 months to complete enrollment in the two phase III studies we recently initiated for the treatment of IDA regardless of the underlying cause 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 ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme in new indications and in territories outside of the U.S., (3) the fact that we have limited experience developing and commercializing a pharmaceutical product on our own or with a partner like Takeda, particularly outside of the U.S., (4) uncertainties regarding our ability to ensure favorable coverage, pricing and reimbursement for Feraheme, (5) uncertainties regarding our ability to manufacture Feraheme, (6) uncertainties relating to our patents and proprietary rights, (7) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, and (8) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2009. 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.

Forward Looking Statements Related to Takeda

This press release contains forward-looking statements regarding the Company's plans, outlook, strategies, and results for the future.

All forward-looking statements are based on judgments derived from the information available to the Company at this time. Forward looking statements can sometimes be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "continue," "seek," "pro forma," "potential," "target, " "forecast," or "intend" or other similar words or expressions of the negative thereof.

Certain risks and uncertainties could cause the Company's actual results to differ materially from any forward looking statements contained in this press release. These risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding the Company's business, including general economic conditions in the US and worldwide; (2) competitive pressures; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) decisions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates; and (8) integration activities with acquired companies.

We assume no obligation to update or revise any forward-looking statements or other information contained in this press release, whether as a result of new information, future events, or otherwise.

Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.