Health Canada Approves Feraheme® (ferumoxytol) to Treat Iron Deficiency Anemia in Adults with Chronic Kidney Disease
~AMAG Eligible to Receive a $3 Million Milestone Payment from Takeda Related to the First Commercial Sale of Feraheme in Canada~
LEXINGTON, Mass. & MISSISSAUGA, Ontario--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) and Takeda Canada, Inc. ("Takeda") today announced that Health Canada granted marketing approval on December 8, 2011 for Feraheme® (ferumoxytol) Injection for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). Under an agreement with AMAG, Takeda has an exclusive license to market Feraheme for all therapeutic applications in Canada. Upon the first commercial sale of Feraheme in Canada, AMAG will receive a milestone payment of $3 million.
"The approval of Feraheme by Health Canada is an important milestone for AMAG and our efforts to expand its reach to new geographies and broader patient populations," said Frank E. Thomas, chief operating officer and interim president and chief executive officer of AMAG. "To that end, we have marketing applications for ferumoxytol to treat IDA in adult CKD patients currently under review in other regions, including Europe. Additionally, we plan to complete enrollment in a global registration program for the broader indication of iron deficiency anemia in early 2012, which will be the basis for global regulatory filings to expand the indication beyond CKD."
"We are pleased that this approval will provide an effective new treatment option for adults in Canada living with iron deficiency anemia related to their chronic kidney disease," said Mike Egli, General Manager, Takeda Canada, Inc. "We are poised to maximize Feraheme's entry into Canada and are pleased to be able to provide this new treatment option to patients."
Feraheme has been available in the United States for more than two years and has been shown to be safe and effective in improving two key markers of iron deficiency anemia-Hgb and TSAT levels-in both dialysis and non-dialysis dependent CKD patients. In Canada, Feraheme will be administered in two 510 mg IV injections two to eight days apart. The two 510 mg doses can be delivered in under 1 minute each.
According to Health Canada, approximately 1.9 to 2.3 million people are living with CKD, many with iron deficiency anemia.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that manufactures and markets Feraheme® in the United States. For additional company information, please visit www.amagpharma.com.
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.
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 striving toward better health for individuals and progress in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
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. For additional product information, please visit www.feraheme.com.
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, potential milestone payments and royalties we may receive under our collaboration agreement with Takeda and the expected timing thereof, our expectation that Feraheme will be available in Canada in the second quarter of 2012, our expectation to complete enrollment in our global IDA clinical development program in Q1 2012, and our plans to expand the Feraheme(r) indication beyond CKD and make certain global regulatory filings in connection therewith, 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, directly or through our partner Takeda, in the intravenous iron replacement market both in Canada and the U.S., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme(r) in new indications and in territories outside of the U.S., (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme(r), (4) the possibility that the FDA or other foreign regulatory authorities could mandate changes to the Feraheme label that would adversely impact the commercial opportunity for Feraheme in the U.S., Canada or other territories, (5) uncertainties regarding our ability to manufacture Feraheme(r), (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, 2010 and our Quarterly Report on Form 10-Q for the three and nine months ended September 30, 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.