Company Affirms 2015 Financial Outlook
WALTHAM, Mass., May 28, 2015 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals,
Inc. (Nasdaq:AMAG), today announced that it has received a complete
response letter from the U.S. Food and Drug Administration (FDA)
regarding its manufacturing supplement seeking approval for a
single-dose vial of Makena. A complete response letter is a
communication from the FDA that informs companies that an application
cannot be approved in its present form. In the letter, the FDA
requested additional information related to manufacturing procedures
for the single-dose vial at a new third-party manufacturer. The Company
remains committed to commercializing a single-dose vial of Makena and
plans to work with the FDA on a timely response.
Makena, the only FDA-approved treatment indicated to reduce the risk of
preterm birth in women who are pregnant with one baby and who have
spontaneously delivered one preterm baby in the past, is currently
marketed in a multi-dose vial, containing five weekly injections. The
FDA's letter has no impact on the currently marketed version of the
product.
"We believe that the approval of a single-dose vial of Makena could
provide important added flexibility and efficiency for our customers,
with the assurance of a product that meets the FDA's strict quality
requirements for sterile injectables," said William Heiden, chief
executive officer of AMAG. "We continue to plan for a commercial launch
of the single-dose vial now in the fourth quarter of 2015. Importantly,
we do not anticipate today's news changing our financial outlook for
2015."
About Makena(R) (hydroxyprogesterone caproate injection)
Makena(R) is a progestin indicated to reduce the risk of preterm birth
in women with a singleton pregnancy who have a history of singleton
spontaneous preterm birth. The effectiveness of Makena is based on
improvement in the proportion of women who delivered <37 weeks of
gestation. There are no controlled trials demonstrating a direct
clinical benefit, such as improvement in neonatal mortality and
morbidity.
Limitation of use: While there are many risk factors for preterm birth,
safety and efficacy of Makena has been demonstrated only in women with
a prior spontaneous singleton preterm birth. It is not intended for use
in women with multiple gestations or other risk factors for preterm
birth.
Makena should not be used in women with any of the following
conditions: blood clots or other blood clotting problems, breast cancer
or other hormone-sensitive cancers, or history of these conditions;
unusual vaginal bleeding not related to the current pregnancy,
yellowing of the skin due to liver problems during pregnancy, liver
problems, including liver tumors, or uncontrolled high blood pressure.
Before patients receive Makena, they should tell their healthcare
provider if they have an allergy to hydroxyprogesterone caproate,
castor oil, or any of the other ingredients in Makena; diabetes or
prediabetes, epilepsy, migraine headaches, asthma, heart problems,
kidney problems, depression, or high blood pressure.
In one clinical study, certain complications or events associated with
pregnancy occurred more often in women who received Makena. These
included miscarriage (pregnancy loss before 20 weeks of pregnancy),
stillbirth (fetal death occurring during or after the 20th week of
pregnancy), hospital admission for preterm labor, preeclampsia (high
blood pressure and too much protein in the urine), gestational
hypertension (high blood pressure caused by pregnancy), gestational
diabetes, and oligohydramnios (low amniotic fluid levels).
Makena may cause serious side effects including blood clots, allergic
reactions, depression, and yellowing of the skin and the whites of the
eyes. The most common side effects of Makena include injection site
reactions (pain, swelling, itching, bruising, or a hard bump), hives,
itching, nausea, and diarrhea.
For additional U.S. product information, including full prescribing
information, please visit www.makena.com.
About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company with a
focus on maternal health, the treatment of iron deficiency anemia in
patients with chronic kidney disease and cancer supportive care. The
primary goal of AMAG is to bring to market therapies that provide clear
benefits and improve patients' lives. In addition to continuing to
pursue opportunities to make new advancements in patients' health and
to enhance treatment accessibility, AMAG intends to continue to expand
and diversify its portfolio through the in-license or purchase of
additional pharmaceutical products or companies, including
revenue-generating commercial products and late-stage development
assets that leverage the company's corporate infrastructure, sales
force call points and commercial expertise. For additional company
information, please visit www.amagpharma.com.
Safe Harbor Statement
This press release contains forward-looking information about AMAG
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 plans to respond to the FDA, including
the expected timeline and review cycle; beliefs about the flexibility
and efficiency of the single-dose, preservative-free vial of Makena;
expectations for the commercial launch of the single-dose vial; AMAG's
financial outlook and plans to continue to expand and diversify its
portfolio; as well as AMAG's efforts to provide products with clear
benefits that improve patients' lives 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, AMAG's ability to
successfully implement Makena's lifecycle management program, including
to effectively respond to the FDA's complete response letter by, among
other things, providing the additional information requested by the FDA
regarding manufacturing procedures and methods used to control the
microbiological environment in which the product is produced and the
sterilization of equipment used in production; the impact of AMAG's
response to the FDA's request that AMAG consider changing the color
combination on the container label and carton labelling to provide more
optimal readability; AMAG's ability to implement the commercial launch
of the new single-dose vials of Makena, including on the anticipated
timeline; the impact of perceptions related to pricing and access on
Makena's commercial success and growth prospects; AMAG's ability to
have Makena manufactured in sufficient quantities and at acceptable
costs to meet commercial demand and clinical development needs and such
other risks identified in AMAG's filings with the U.S. Securities and
Exchange Commission (SEC), including its Annual Report on Form 10-K for
the fiscal year ended December 31, 2014 and subsequent filings with the
SEC. Any of these 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(R) is a registered trademark of AMAG
Pharmaceuticals, Inc. Lumara Health(TM) and Makena(R) are trademarks of
Lumara Health IP Ltd.
CONTACT: Linda Lennox
Vice President, Investor Relations & Corporate Communications
617-498-2846