NEW YORK, Jan. 9, 2015 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of AMAG Pharmaceuticals, Inc. ("AMAG" or the "Company"). Such investors are advised to contact Robert S. Willoughby at firstname.lastname@example.org or 888-476-6529, ext. 237.
The investigation concerns whether AMAG and certain of its officers and/or directors have violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
On December 21, 2012, AMAG submitted to the U.S. Food and Drug Administration (the "FDA") a supplemental New Drug Application (the "sNDA") under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Feraheme (ferumoxytol) Injection, 510 mg. The sNDA sought approval for a broader indication for Feraheme for the treatment of iron deficiency anemia in adult patients who have failed or could not use oral iron. On September 23, 2013, the Company received a notification from the FDA stating that, as part of its ongoing review of the Company's sNDA, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments by September 23, 2013, a target date previously communicated by the FDA in a letter dated March 5, 2013. On September 25, 2013 the Company announced in an Securities and Exchange Commission Form 8-K filing, information regarding the FDA notification received on September 23, 2013.
On January 7, 2014, the Company had a discussion with the FDA regarding the status of the review of the sNDA. The FDA indicated that the sNDA is under active review; however, the FDA has not yet entered into discussions with the Company regarding proposed labeling or postmarketing requirement/commitment requests for the broader indication for Feraheme.
On January 22, 2014, the Company announced that the FDA has issued a complete response letter for the supplemental new drug application for Feraheme (ferumoxytol) injection for intravenous use. The sNDA sought to expand the indication for Feraheme beyond the current chronic kidney disease indication to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment. In the letter, the FDA stated that AMAG has not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed indication. The FDA indicated that its decision was based on the cumulative ferumoxytol data, including the global phase III IDA program and global post-marketing safety reports. The FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death.
On this news, shares of AMAG fell $1.68 per share to more than 7.69% on intraday trading to a price of $20.18 on January 22, 2014.
On January 9, 2015 the Company announced that, "on June 2, 2014, AMAG Pharmaceuticals, Inc. (the "Company") proposed to the U.S. Food and Drug Administration ("FDA") changes to the current U.S. label of Feraheme (ferumoxytol) Injection based on a review of global post-marketing data. The intended purpose of the label changes in the U.S. was to strengthen the warnings and precautions section of the label and mitigate the risk of serious hypersensitivity reactions, including anaphylaxis, in order to enhance patient safety. The proposed changes were subject to review and approval by the FDA.
After considering the Company's June 2014 submission and other information, on January 7, 2015, the FDA notified the Company that it believes new safety information should be included in the labeling for Feraheme, including, among other things, a boxed warning to highlight the risks of serious hypersensitivity/anaphylaxis reactions and revisions that Feraheme should only be administered through an intravenous ("IV") infusion (i.e., not by IV injection) and should be contraindicated for patients with any known history of drug allergy. The FDA's recommended label changes go beyond what the Company proposed in June 2014."
On this news, shares of AMAG fell $3.13 per share to more than 6.81%, on intraday trading to a price of $42.85 on January 9, 2015.
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Robert S. Willoughby
SOURCE Pomerantz LLP