BOSTON, Jan. 5, 2017 /PRNewswire/ -- Juniper
Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a
women's health therapeutics company, today announced that an
abstract describing data exploring current practices among U.S.
obstetricians to screen, define, and treat a short cervix to
prevent preterm birth has been selected for poster presentation at
Society for Maternal-Fetal Medicine ("SMFM")'s 37th Annual
Pregnancy Meeting as follows:
Title: "Assessing Screening and
Treatment Patterns for Short Cervical
Length (SCL)
in Pregnancy" (Program ID No. 403)
Date: Thursday, January 26, 2017
Time: 4:00 p.m. - 5:30 p.m.
Location: Octavius Ballroom, Caesar's Palace, Las Vegas, Nevada
The abstract is included in the SMFM Supplement entitled
Society for Maternal-Fetal Medicine: 2017 37th
Annual Meeting: The Pregnancy Meeting, accessible through the
American Journal of Obstetrics and Gynecology website at
http://www.ajog.org/article/S0002-9378(16)31640-4/fulltext.
Data from this study, funded by Juniper Pharmaceuticals, was
presented as part of the confidential pre-IND briefing package that
the Company discussed with the U.S. Food and Drug Administration
("FDA") in November in relation to its progesterone intravaginal
ring ("IVR"), JNP-0301.
The Company is developing JNP-0301 to deliver natural
progesterone to treat women with short cervical length who are at
risk of delivering before 37 weeks gestation. The constructive
pre-IND meeting was the first step towards determining a potential
clinical development pathway that could lead to an eventual product
approval.
Prototype formulation development is underway, with IND-enabling
studies planned for 2017. The Company expects to initiate
definitive sheep studies by year-end 2017 which, among other
planned activities, could potentially enable an IND submission in
the first half of 2018 for JNP-0301.
About Short Cervical Length in Pregnancy
The cervix is a cylinder-shaped neck of tissue that connects the
vagina and uterus. Located at the lowermost portion of the uterus,
the cervix is composed primarily of fibromuscular tissue. As
a pregnancy advances, the cervix progressively shortens and thins
to permit the infant's birth.
In a typical pregnancy, the average cervical length at 24 weeks
gestation is 3.5 cm. A short cervical length at mid-pregnancy is
the strongest indicator of a pregnant woman's risk of preterm
birth. When cervical length is less than 2.2 cm, women face a
20 percent probability of preterm delivery1.
SMFM recommends screening women with no history of prior
spontaneous preterm birth for short cervical length at 18 to 24
weeks gestation. In women with singleton gestations, no prior
history of PTB, and cervical length measuring less than or equal to
20mm at ≤24 weeks, SMFM advocates daily administration of vaginal
progesterone from time of diagnosis to 36 weeks
gestation2.
There are currently no FDA-approved drugs, vaginal progesterone
or otherwise, to treat women at risk of preterm birth due to
short cervical length.
About Preterm Birth
Preterm birth is the delivery before 37 weeks gestation.
Globally, 15 million babies are born prematurely each year, and one
million will die. The average medical cost for a premature
baby is over $50,000, more than ten
times that of a healthy infant.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. is focused on developing therapeutics
that address unmet medical needs in women's health. The
Company is advancing a pipeline of proprietary product
candidates that leverage its differentiated intravaginal
ring technology and when appropriate the 505(b)(2) regulatory
pathway. Targeted product development investments are enabled
by Juniper's core operating business: the
Crinone® (progesterone gel) franchise
and Juniper Pharma Services, which provides high-end
fee-for-service pharmaceutical development and clinical trials
manufacturing to clients. Please
visit www.juniperpharma.com for more information.
Juniper Pharmaceuticals™ is a trademark of Juniper
Pharmaceuticals, Inc., in the U.S. and EU.
Crinone® is a registered trademark of Merck KGaA,
Darmstadt, Germany, outside the
U.S. and of Allergan, Inc. in the U.S.
1. Iams JD, Goldenberg RL, et al. The length
of the cervix and the risk of spontaneous premature delivery. N
Engl J Med, 1996; 334: 567–572.
2. Society for Maternal-Fetal
Medicine. Progesterone and preterm birth prevention:
translating clinical trials data into clinical
practice. American Journal of Obstetrics &
Gynecology, May 2012, Volume 206,
Issue 5, 376 – 386.
Forward Looking Statements
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to the
anticipated clinical program for JNP-0301, the expected timing of
prototype completion and planned IND-enabling and sheep studies,
the potential timing of an IND submission for JNP-0301, Juniper's
ability to leverage the 505(b)(2) pathway
for product candidates and the expectation that the core
operating business will enable targeted product development
investments. Management believes that these
forward-looking statements are reasonable as and when made.
However, such forward-looking statements involve known and unknown
risks, uncertainties, and other factors that may cause actual
results to differ materially from those projected in the
forward-looking statements. These risks and uncertainties
include, but are not limited to: risks associated with
the drug development process generally, including the timely
completion of prototype development and planned IND-enabling and
sheep studies; risks associated with the outcomes of the prototype
formulation development efforts and planned IND-enabling and sheep
studies and whether they support further development of JNP-0301 or
our other product candidates; risks associated with the regulatory
review process, including the risk that the FDA does not ultimately
accept our proposed clinical program for JNP-0301; the risk that
the results of previously conducted studies involving our product
candidates will not be repeated or observed in ongoing or future
studies or following commercial launch, if such product candidates
are approved; risks associated with obtaining, maintaining and
protecting intellectual property; risks associated with Juniper
Pharmaceuticals' ability to enforce its patents against infringers
and defend its patent portfolio against challenges from third
parties; the risk of competition from currently approved therapies
and from other companies developing products for similar uses; risk
associated with Juniper Pharmaceuticals' ability to manage
operating expenses and/or obtain additional funding to support its
business activities; and risks associated with Juniper
Pharmaceuticals' dependence on third parties. For a
discussion of certain risks and uncertainties associated
with Juniper Pharmaceuticals' forward-looking
statements, please review the Company's reports filed
with the SEC, including, but not limited to, its Annual Report on
Form 10-K/A for the period ended December 31, 2015 and
Quarterly Report on Form 10-Q for the period ended September 30, 2016 as filed with the SEC on
November 14, 2016. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date on which they are made.
These statements are based on management's current expectations
and Juniper Pharmaceuticals does not
undertake any responsibility to revise or update any
forward-looking statements contained herein, except as expressly
required by law.
Investor Contact:
Amy Raskopf
Director, Corporate Communications, Juniper Pharmaceuticals,
Inc.
(917) 673-5775 / araskopf@juniperpharma.com
Media Contact:
Amy Covino
Tell Med Strategies
(201) 774-3111 / amy.covino@tmstrat.com
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SOURCE Juniper Pharmaceuticals, Inc.