Antares Pharma, Inc. (NASDAQ:ATRS) today announced the successful
regulatory outcome of the Makena® subcutaneous auto injector
collaboration with AMAG Pharmaceuticals (AMAG) (NASDAQ:AMAG). AMAG
announced U.S. Food and Drug Administration (FDA) approval for
their supplemental New Drug Application for Makena®
(hydroxyprogesterone caproate injection) subcutaneous auto injector
drug-device combination product, which was designed as a
ready-to-administer 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. This drug-device
combination product utilizes the Antares Pharma QuickShot® device
which was specifically developed to deliver a rapid injection of
highly viscous drug products such as progesterone in oil, through a
fine gauge nonvisible needle.
“Today’s announcement represents the first FDA
approval of a drug-device combination product utilizing our
QuickShot auto injector. This first pass approval was made possible
through an excellent working collaboration with our device team and
the development group at AMAG,” said Robert F. Apple, President and
Chief Executive Officer of Antares Pharma. “The Makena
QuickShot device was designed to enhance performance on the
attributes we believe are most critical to healthcare providers and
patient acceptance, including decreased time to administer and use
of a shorter, thinner nonvisible needle for subcutaneous injection,
while potentially providing an alternative to the existing
intramuscular methods of administration. We look forward to our
continuing partnership with AMAG as it transitions from development
to a commercial supply relationship.”
In September 2014, Antares Pharma entered into a
license, development and supply agreement to develop a variation of
our VIBEX® QuickShot® subcutaneous auto injector for use with
Makena®. Under this arrangement, AMAG will manufacture and
supply the drug product to Antares. Antares will manufacture
the device and be responsible for the assembly and packaging of the
final product which will be sold to AMAG at cost plus margin.
AMAG is also responsible for commercialization and distribution of
the final product. Antares will receive high single digit to
low double digit royalties on net sales as well as sales
milestones.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.
The most common side effects reported with the Makena auto-injector
use (and higher than with the Makena intramuscular injection) was
injection site pain.
For additional product information, including full prescribing
information, please
visit www.makena.com.
About QuickShot® Auto
Injector
The proprietary QuickShot® auto injector is
designed to allow rapid subcutaneous self-administration of highly
viscous drugs in oil such as testosterone or progesterone and
biologics using high spring pressure through a fine gauge
needle. Conventional auto injectors, or even a vial, needle
and syringe are not able to inject highly viscous drugs efficiently
or as fast and easy as the QuickShot® device. The QuickShot®
auto injector can also provide the patient with the ease and speed
of self-administration, comfort and discretion.
About Antares Pharma
Antares Pharma focuses on self-administered
parenteral pharmaceutical products. The Company’s product, OTREXUP®
(methotrexate) injection for subcutaneous use, is approved in the
U.S. for the treatment of adults with severe active rheumatoid
arthritis, children with active polyarticular juvenile idiopathic
arthritis and adults with severe recalcitrant psoriasis. The
Company’s product Sumatriptan Injection USP, is approved in the
U.S. for the acute treatment of migraine and cluster headache and
is distributed by Teva Pharmaceutical Industries, Ltd. (Teva).
Antares Pharma is also developing an investigational new drug,
XYOSTED™, for the treatment of testosterone deficiency
(hypogonadism). The Company filed a New Drug Application for
XYOSTED™ and received a Complete Response Letter. The
Company's technology platforms include VIBEX® disposable auto
injectors and disposable multi-use pen injectors. Antares Pharma
has license, development and supply agreements with Teva that
include VIBEX® epinephrine, exenatide multi-dose pen, and
teriparatide multi-dose pen. The Company also provides AMAG
Pharmaceuticals with a subcutaneous QuickShot® auto injector for
administering Makena® (hydroxyprogesterone
caproate injection). For more information, visit
www.antarespharma.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995. Forward-looking statements are subject to certain risks
and uncertainties that can cause actual results to differ
materially from those described. Factors that may cause such
differences include, but are not limited to: the timing of the
commercial launch of the Makena subcutaneous auto injector product
in the U.S. and future market acceptance and revenue from the
Makena subcutaneous auto injector product; the outcome of the Type
A meeting with the U.S. Food and Drug Administration (FDA), the
Company’s ability to resolve the deficiencies identified by the FDA
in the Complete Response Letter, the timeframe associated with such
resolution and whether any such response will be accepted by the
FDA, FDA approval of the Company’s NDA for XYOSTED
and future market acceptance and revenue for XYOSTED;
successful completion of the transaction with Ferring
International Center, S.A. and satisfaction of the various
conditions in the Ferring asset purchase agreement and payment of
the full purchase price; Teva’s expectations about timing and
approval of the VIBEX® epinephrine pen ANDA by the FDA and
potential product launch of the same, the therapeutic equivalence
rating thereof, and any future revenue from the same; FDA action
with respect to Teva’s Abbreviated New Drug Application (“ANDA”)
for the Teriparatide multi-dose pen and the timing and approval, if
any, by the FDA of the same; FDA action with respect to Teva’s ANDA
for the Exenatide pen and the timing and approval, if any, by the
FDA of the same; Teva’s ability to successfully commercialize
VIBEX® Sumatriptan Injection USP and the amount of revenue from the
same;; continued growth of prescriptions and sales of
OTREXUP®; the timing and results of research projects,
clinical trials, and product candidates in development;
actions by the FDA or other regulatory agencies with the respect to
the Company’s products or product candidates of its partners;
continued growth in product, development, licensing and royalty
revenue; the Company’s ability to obtain financial and other
resources for its research, development, clinical, and commercial
activities and other statements regarding matters that are not
historical facts, and involve predictions. These statements involve
known and unknown risks, uncertainties and other factors that may
cause actual results, performance, achievements or prospects to be
materially different from any future results, performance,
achievements or prospects expressed in or implied by such
forward-looking statements. In some cases you can identify
forward-looking statements by terminology such as ''may'',
''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'',
''anticipate'', ''believe'', ''estimate'', ''predict'',
''potential'', ''seem'', ''seek'', ''future'', ''continue'', or
''appear'' or the negative of these terms or similar expressions,
although not all forward-looking statements contain these
identifying words. Additional information concerning these and
other factors that may cause actual results to differ materially
from those anticipated in the forward-looking statements is
contained in the "Risk Factors" section of the Company's Annual
Report on Form 10-K for the year ended December 31, 2016, and in
the Company's other periodic reports and filings with the
Securities and Exchange Commission. The Company cautions
investors not to place undue reliance on the forward-looking
statements contained in this press release. All forward-looking
statements are based on information currently available to the
Company on the date hereof, and the Company undertakes no
obligation to revise or update these forward-looking statements to
reflect events or circumstances after the date of this press
release, except as required by law.
Contact:Jack HowarthVice President, Corporate
Affairs of Antares609-359-3016jhowarth@antarespharma.com
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