AMAG PHARMACEUTICALS,INC. (NASDAQ:AMAG) Files An 8-K Regulation FD DisclosureItem 7.01 Regulation FD.
On March 23, 2018, AMAG Pharmaceuticals, Inc. (“AMAG” or the “Company”) and Sandoz Inc. entered a stipulation of dismissal, in the United States District Court for the District of New Jersey, to a settlement agreement, that dismisses and resolves the U.S. patent litigation related to the Company’s Feraheme, 30 mg/mL, 17mLsingle dose vials, for intravenous use (“IV”).
The Company believes that this mutually agreeable settlement with Sandoz, along with the recent label expansion approval, provides a clear path forward for the continued growth of Feraheme in the U.S. IV iron market. The U.S. IV iron market is made up of five branded products today, three of which have been off patent for several years. Despite attempts by a number of manufacturers to develop generic versions, there is only one generic IV iron available, which was approved seven years ago. The Company believes this may be due to the challenges associated with the manufacture and demonstration of bioequivalence for such highly complex molecules.
According to the terms of the settlement, ifSandozreceives FDA approval by a certain date, Sandoz may launch its generic version of Ferahemeon July 15, 2021, or earlier under certain circumstances customary for settlement agreements of this nature. Sandoz will pay a royalty on the sales of its generic version of Feraheme to AMAG until the expiration of the last Feraheme patent listed in the Orange Book.IfSandozis unable to secure approval by such date,Sandozwill launch an authorized generic version of Feraheme on July 15, 2022 for up to twelve months.Sandoz’s right to distribute, and AMAG’s obligation to supply, the authorized generic product shall be in accordance with standard commercial terms and profit splits.
Forward-Looking Statements
This press release contains forward-looking information aboutAMAG Pharmaceuticals, Inc.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, among others, AMAG’s beliefs about the settlement agreement, including beliefs that, along with the recent label expansion approval, it provides a clear path forward for the continued growth of Feraheme in the U.S. IV iron market; AMAG’s beliefs about the complex nature of IV iron products and the inability of third parties to develop generic versions of IV iron products due to the challenges associated with the manufacture and demonstration of bioequivalence; and expectations regarding Sandoz’s and AMAG’s future efforts under the settlement agreement 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, among others, those other risks identified in the Company’s filings with theU.S. Securities and Exchange Commission(the “SEC”), including its Annual Report on Form 10-K for the year endedDecember 31, 2017 and subsequent filings with the SEC. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG disclaims 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.
AMAG Pharmaceuticals® and Feraheme® are registered trademarks ofAMAG.
About AMAG PHARMACEUTICALS,INC. (NASDAQ:AMAG)
AMAG Pharmaceuticals, Inc. is a pharmaceutical company. The Company’s segment is the manufacture, development and commercialization of products and services for use in treating various conditions, with a focus on maternal health, anemia management and cancer supportive care. Its offerings focus on maternal health, anemia management and cancer supportive care, including its product, Makena (hydroxyprogesterone caproate injection); services related to the collection, processing and storage of umbilical cord blood stem cell and cord tissue units operated through Cord Blood Registry (CBR); its product, Feraheme (ferumoxytol), for intravenous (IV) use, and MuGard Mucoadhesive Oral Wound Rinse. It is engaged in the development of Digoxin immune fab, a polyclonal antibody for the treatment of severe preeclampsia in pregnant women. Makena is a drug indicated to reduce the risk of preterm birth in women pregnant with a single baby having a history of singleton spontaneous preterm birth.
