BOSTON, Jan. 6, 2017
/PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq:
JNP) ("Juniper" or the "Company") today announced plans for 2017
that are expected to enable the Company to submit Investigational
New Drug (IND) applications for its hormone-delivery intravaginal
ring (IVR) candidates in the first half of 2018. These plans
build on recent developments including:
- Significant technical progress on IVR platform technology,
including initial data from cGMP-quality prototypes demonstrating
that Juniper's IVR achieves sustained release of progesterone and
estrogen;
- Novel sheep model established for IVR evaluations, beginning
with JNP-0101 in which in vitro-in vivo pharmacokinetic
correlations were observed, which can facilitate IVR design
advancements with rapid testing of various formulations; and,
- Pre-IND meeting with the U.S. Food and Drug Administration
("FDA") regarding the development pathway for the JNP-0301
progesterone IVR for the prevention of preterm birth.
"We enter 2017 in a position of strength, bolstered by our
recent cash infusion from Allergan and the valuable financial
leadership that our new CFO Jeff
Young brings to our growing team," said Alicia Secor, Juniper's President and Chief
Executive Officer. "We are well-positioned to self-fund our
operations, including targeted investments in our internal pipeline
candidates and our CDMO, Juniper Pharma Services, in 2017 while
maintaining a healthy balance sheet throughout the year."
"Our strategy is to build value by developing and bringing to
market innovative therapies to meet the healthcare needs of women.
Women represent over 50% of the US population, yet treatment
options for common conditions beyond contraception are limited,"
Ms. Secor continued. "We aim to address conditions such as
menopausal symptoms, overactive bladder, and preterm birth, but
also to remove the stigma and inspire the conversations that will
foster a vibrant community of healthy, empowered women."
JNP-0301 for Preterm Birth Prevention
In the
fourth quarter of 2016, the Company held a constructive pre-IND
meeting with the FDA for JNP-0301, its natural progesterone IVR in
development for the prevention of preterm birth (PTB) in women with
a short cervical length at mid-pregnancy (SCL). In the U.S.
alone, the prevalence of women at risk for PTB due to SCL (defined
as <25 mm) is estimated to be around 400,000. The incidence of
this condition is expected to rise as more physicians adopt the
current medical guidelines to screen for SCL in all pregnant
women. There is currently no FDA-approved drug to prolong
gestation in this patient population.
"We look forward to further dialogue with the Agency as we
advance our IND-enabling work and seek to finalize the clinical
program design for JNP-0301," noted Dr. Bridget Martell,
Juniper's Chief Medical Officer.
Prototype testing is underway, and benefits from the concurrent
work being done on JNP-0201. Juniper expects to conduct
IND-enabling studies with JNP-0301 in 2017 and to initiate
definitive sheep studies by year-end 2017 which, among other
planned activities, are expected to enable an IND submission in the
first half of 2018 for JNP-0301.
With 15 million babies born before 37 weeks gestation around the
world each year, and 1.1 million deaths annually due to
complications of preterm birth, Juniper will also seek scientific
and regulatory input in other geographies to support development to
meet the global unmet need.
JNP-0201: Hormone Replacement Therapy (HRT) for
Menopause
Prototype testing is also underway for
JNP-0201, which employs the multi-segmented capability of the
Juniper IVR for HRT to deliver natural estrogen and progesterone to
alleviate symptoms of menopause in women.
An estimated 45 million women are either menopausal or
approaching menopause in U.S. alone. The domestic market was valued
at over $4 billion in 2015,
comprising both pharmacy-compounded and FDA-approved therapies for
HRT.
The Company will focus on IND-enabling activities for JNP-0201,
including a definitive sheep study to be initiated by year-end
2017. An IND for JNP-0201 is also planned for the first half
of 2018.
JNP-0101 for Overactive Bladder (OAB)
Building
on preclinical data from a recently-completed pilot study in a
sheep model, Juniper is refining the cGMP formulation of JNP-0101,
its oxybutynin IVR for the treatment of OAB in women, to address
the unique properties of this molecule.
OAB is characterized by involuntary contraction of the detrusor
muscles before the bladder is full. This chronic urological
condition affects an estimated 20 million women in the U.S., with
approximately nine million receiving pharmacologic therapy. The
domestic market for OAB therapeutics was approximately
$2.3 billion in 2015.
Pursuing Multiple
Strategic Opportunities
In
addition to making investments in Juniper Pharma Services and
measured development of the aforementioned IVR candidates, Juniper
is actively exploring new strategic opportunities, including:
- Collaborations to apply the IVR technology platform and
technical expertise in polymer science with other companies'
therapeutic agents;
- Partnerships for internally-developed candidates;
- Pipeline expansion through in-licensing or acquisition of
externally-developed women's health therapeutics.
"Business development is a key strategic focus for 2017. While
advancing our pipeline internally, we intend to leverage our many
assets and maintain optionality for our programs to maximize value
for shareholders," Ms. Secor concluded.
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.
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
clinical and market potential of Juniper's product candidates, the
anticipated clinical programs for Juniper's product candidates, the
expected timing of prototype completion and planned IND-enabling
and sheep studies for these product candidates, the potential
timing of IND submissions for JNP-0301 and JNP-0201, Juniper's
ability to leverage the 505(b)(2) pathway for
its product candidates, Juniper's cash position and
ability to fund these development programs and operations
internally, and Juniper's ability to complete one or more strategic
transactions such as a collaboration agreement or new product
acquisition. 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
development efforts and planned IND-enabling and sheep studies and
whether they support further development of Juniper's product
candidates; risks associated with the regulatory review
process, including the risk that the FDA does not ultimately accept
Juniper's proposed clinical program for JNP-0301; the outcomes of
planned clinical trials and the regulatory review process; the risk
that the results of previously conducted studies involving
Juniper's 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 / ir@juniperpharma.com
Media Contact
Amy Covino
Tell Med Strategies
(201) 774-3111 / amy.covino@tmstrat.com
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SOURCE Juniper Pharmaceuticals, Inc.