AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the
issuance of U.S. Patent Number 9,844,558 entitled
“Methods of Reducing Risk of Preterm Birth.” This newly issued
patent is directed to subcutaneous administration and dosing of
Makena® (hydroxyprogesterone caproate injection) and is expected to
expire on May 2, 2036. Makena is a treatment to reduce the risk of
preterm birth in women who are pregnant with one baby and who
spontaneously delivered one preterm baby in the past.
The U.S. Food and Drug Administration (FDA) established a
Prescription Drug User Fee Act (PDUFA) target action date of
February 14, 2018 for the Makena subcutaneous auto-injector, a
drug-device combination product. If approved, the auto-injector
will join the Makena portfolio, which also includes the
FDA-approved intramuscular injection.
“Securing this patent is another important step in our
preparation to bring the Makena subcutaneous auto-injector to
market,” said William Heiden, AMAG’s president and chief executive
officer. “If approved, this drug-device combination will offer
health care providers with a ready-to-administer product and
provide women with an alternative option to an intramuscular
injection. We believe that this auto-injector will help more women
who may be at risk for recurrent preterm birth.”
AMAG developed the Makena auto-injector with its device partner
Antares Pharma, Inc. (NASDAQ:ATRS), which holds issued patents on
the auto-injector device and drug device combination. If approved,
AMAG will request FDA Orange Book listing of this new patent, as
well as the eligible Antares patents.
About AMAGAMAG is a biopharmaceutical company
focused on developing and delivering important therapeutics,
conducting clinical research in areas of unmet need and creating
education and support programs for the patients and families we
serve. Our currently marketed products support the health of
patients in the areas of maternal and women’s health, anemia
management and cancer supportive care. Through CBR®, we also help
families to preserve newborn stem cells, which are used today in
transplant medicine for certain cancers and blood, immune and
metabolic disorders, and have the potential to play a valuable role
in the ongoing development of regenerative medicine. For additional
company information, please
visit www.amagpharma.com.
About Makena® (hydroxyprogesterone caproate
injection) Makena is a progestin indicated to reduce the
risk of preterm birth in women pregnant with a single baby 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 product information, including full prescribing
information, please visit www.makena.com.
Forward-Looking Statements 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 ability to bring the Makena
subcutaneous auto-injector to market; AMAG’s belief that the
auto-injector will, if approved, help more women who may be at risk
for preterm birth; the ability to list eligible patents in the
Orange Book and beliefs that newborn stem cells have the potential
to play a valuable role in the development of regenerative medicine
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 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
year ended December 31, 2016, its Quarterly Reports on Form 10-Q
for the quarters ending March 31, 2017, June 30, 2017 and September
30, 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® is a registered trademark of AMAG
Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG
Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR® are
registered trademarks of Cbr Systems, Inc.
AMAG Pharmaceuticals, Inc. Contacts:
Investors:Linda Lennox Vice President, Investor Relations
617-498-2846
Media: Sarah ConnorsSenior Director, Product Communications
781-296-0722
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