LEXINGTON, Mass.--()--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization in Switzerland for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). Ferumoxytol was approved for the same indication in the European Union in June 2012, and in the United States and Canada under the brand name Feraheme® in June 2009 and December 2011, respectively.
“International expansion is one of four key areas of opportunity for Feraheme/Rienso, and Swiss approval marks continued progress on this front”
AMAG’s partner, Takeda Pharmaceutical Company Limited, is responsible for commercialization of ferumoxytol in Switzerland, the EU and Canada, among other territories. Takeda plans to launch ferumoxytol in Switzerland under the brand name Rienso®. AMAG is entitled to receive tiered, double-digit royalties on product sales in the licensed territories. AMAG has sole commercial rights for Feraheme in the United States.
“International expansion is one of four key areas of opportunity for Feraheme/Rienso, and Swiss approval marks continued progress on this front,” said William Heiden, president and chief executive officer of AMAG. “Through Takeda’s commercial efforts, Feraheme/Rienso will soon be available to CKD patients in several countries around the world as a new treatment option for their iron deficiency anemia. We believe that these international launches, coupled with continued market penetration in the United States, the potential for a broad IDA label and overall IV iron market expansion, provide multiple avenues of growth for Feraheme.”
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.1 IV iron is recommended for use to increase hemoglobin levels in CKD patients with IDA. 1
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical 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)/Rienso
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 US Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the US shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011, where it will be marketed by Takeda as Feraheme®, and in the European Union in June 2012 and Switzerland in August 2012, where it will be marketed by Takeda as Rienso®. 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 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.
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 areas of significant growth opportunities for Feraheme, Takeda’s expected launch of ferumoxytol in Switzerland, and any royalties we may receive following such launch 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 and Switzerland, (2) 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 in territories outside of the US, including the EU, (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (4) uncertainties regarding our ability to manufacture Feraheme/Rienso, (5) uncertainties relating to our patents and proprietary rights, and (6) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2012. 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.