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AMAG Pharmaceuticals, Inc. (AMAG) Gets Initial EU Nod, Potentially Bagging a $30 Million Milestone Payment From Takeda Pharmaceutical Co. Ltd. (TKDG.DE)


4/20/2012 10:42:53 AM

LEXINGTON, Mass.--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of ferumoxytol, an intravenous (IV) iron therapy, for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). In the European Union, ferumoxytol will be marketed as Rienso® by AMAG’s partner, Takeda Pharmaceutical Company Limited.

“International expansion of ferumoxytol is an important growth opportunity for AMAG,” said Frank Thomas, interim president and chief executive officer of AMAG. “Following the approval of ferumoxytol in Canada, which we received in late 2011, European approval would mark the third region where ferumoxytol would be available for the treatment of iron deficiency anemia in patients with CKD. Continued growth in our U.S. CKD business, coupled with geographic expansion and the opportunity to further expand the product’s label to include all patients with IDA, would significantly enhance the growth prospects for ferumoxytol.”

European approval and the subsequent first commercial sale of ferumoxytol in Europe would trigger $30 million in milestone payments to AMAG from Takeda. Additionally, AMAG is entitled to receive tiered, double-digit royalties on sales of ferumoxytol in licensed territories. Upon EU Commission approval, Takeda is planning to launch Rienso in the second half of 2012.

“Iron deficiency anemia can be a debilitating condition for chronic kidney disease patients and appropriate management of this condition can carry positive clinical implications for patients. Therefore, treatment of anemia at all stages of CKD is important and the potential availability of ferumoxytol in Europe would offer an additional therapeutic option to help effectively manage this condition,” said Professor Iain Macdougall 1, consultant nephrologist and professor of clinical nephrology at King’s College Hospital, London.

Iron deficiency is a common cause of anemia in CKD patients, and is very common in the later stages of CKD as renal function deteriorates and erythropoiesis (red blood cell production) declines. IDA can have a profound impact on patients’ lives, causing fatigue, shortness of breath and an increase in the risk of cardiovascular complications including congestive heart failure.2 IV iron is recommended for use to increase hemoglobin levels in CKD patients with IDA and can also serve to minimize the dose of ESA required to manage anemia in CKD. 2 Approximately one million grams of IV iron are administered to IDA patients in the EU each year.

About AMAG Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that manufactures and markets ferumoxytol under the brand name Feraheme® in the United States. For additional company information, please visit www.amagpharma.com.

About Feraheme (ferumoxytol)

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 received marketing approval in Canada in December 2011. For additional product information, please visit www.feraheme.com.

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

Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.

1 Dr. Macdougall has been an investigator in clinical trials of ferumoxytol sponsored by AMAG.

2 National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis 2006;47(suppl 3):11–1458

The important safety information below is based on the United States prescribing information.

Important Safety Information About Feraheme

Indication and contraindications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.

Warnings and precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In 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.

Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. 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 serum iron and transferrin bound iron values in the 24 hours following 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.

Adverse reactions

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.

Post-marketing safety experience

The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.

For full prescribing information, please visit www.feraheme.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 potential approval and potential commercial launch of ferumoxytol/Rienso® in the EU, any milestone payments and royalties we may receive following such approval and launch, the potential growth in our US CKD business, geographic expansion, and the opportunity to further expand the Feraheme label to include all patients with IDA, and the potential for each of the foregoing to significantly enhance the growth prospects for ferumoxytol, 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) the risk that ferumoxytol/Rienso® does not receive final marketing approval in the EU from the EMA, (2) uncertainties regarding our and Takeda's ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., including the EU, (3) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme in the broader IDA indication both in the U.S. and in territories outside of the U.S., including the European Union, (4) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, (5) uncertainties regarding our ability to manufacture Feraheme, (6) uncertainties relating to our patents and proprietary rights, and (7) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011. 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.

Contacts

AMAG Pharmaceuticals, Inc.

Amy Sullivan, 617-498-3303



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