BOSTON, Jan. 2, 2018 /PRNewswire/ -- Juniper
Pharmaceuticals (Nasdaq: JNP), a diversified healthcare
company focused on women's health, today provided financial
guidance for 2018, reflecting continued strength in the Company's
core businesses, Juniper Pharma Services (JPS) and
CRINONE® (progesterone gel), and provided an overview of
strategic priorities for 2018. The Company also announced positive
top-line pharmacokinetic data from in vivo animal studies
evaluating each of the Company's three IVR formulations.
"Our plans for 2018 are designed to build upon our strong
performance across our core businesses, JPS and CRINONE, in 2017,"
said Alicia Secor, Chief Executive
Officer. "We are determined to continue the growth trajectory in
both of our core businesses, while remaining financially strong and
fiscally responsible to maximize shareholder value."
Financial Guidance
- Continued strong double-digit revenue growth for
CRINONE® and JPS is expected in 2018.
- Based on growth trends seen in CRINONE® and JPS, and
a continued commitment to prudent use of cash, the Company
anticipates being cash flow positive in 2018.
"Another highlight for 2017 was the successful completion of
in vivo animal studies that we believe supports advancement
of our IVR technology platform. Based on these data, we will
continue to make targeted investments to support certain
IND-enabling activities in our priority program, JNP-0201, while
maintaining optionality to partner this program. We will also
continue to advance discussions with potential partners around
JNP-0101 and JNP-0301," continued Ms. Secor.
Preclinical IVR data
- Rapid absorption of estradiol and progesterone from JNP-0201
IVR was demonstrated, with peak concentrations within the first 4-8
hours.
- Each IVR candidate achieved its targeted release (JNP-0101
delivery of oxybutynin over 28 days, JNP-0201 delivery of natural
progesterone and estradiol over 28 days, and JNP-0301 delivery of
natural progesterone over 14 days) and demonstrated an improved
pharmacokinetic profile with little to no daily fluctuations over
the course of treatment compared to marketed products in direct
in vivo animal studies.
"This IVR technology was designed to deliver molecules of any
size, both low and high molecular weight, as well as multiple drugs
simultaneously at any desired release rate and at a range of doses,
while allowing for controlled delivery over time with extended
duration in a single administration," said Robert Langer, ScD, Institute Professor at
Massachusetts Institute of Technology,
co-developer of the novel IVR technology, and a member of the
Juniper Scientific Advisory Board. "These results suggest that this
technology platform may eventually allow for improved patient
compliance and convenience over other routes of administration with
the potential to address various women's health needs."
Strategic Priorities
- JPS will continue to focus on the expansion of its
pharmaceutical development and manufacturing services to new and
existing customers seeking solutions for difficult to formulate
products. Capital expenditures planned for 2018 will provide
capacity expansion capabilities intended to drive future
growth.
- Active discussions with partner Merck KGaA to extend the
CRINONE® Progesterone Gel agreement are progressing, and
the expansion of this relationship remains a strategic priority for
the Company.
- Partnering opportunities are being explored for JNP-0101, the
oxybutynin IVR for the treatment of overactive bladder (OAB), and
JNP-0301, a natural progesterone IVR for the prevention of pre-term
birth (PTB) in women with a short cervical length at
mid-pregnancy.
- Support of IND-enabling activities for JNP-0201 remains
ongoing, while the Company maintains optionality to partner this
program.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. core businesses include its
CRINONE® (progesterone gel) franchise and Juniper Pharma
Services, which provides high-end fee-for-service pharmaceutical
development and clinical trials manufacturing to clients. The
Company is also leveraging its differentiated intravaginal ring
technology, which offers the potential to address unmet needs in
women's health. 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 plc 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 management's expectations
concerning future financial results and financial condition,
including double-digit revenue growth and becoming cash flow
positive in 2018, statements relating to the preclinical in vivo
animal data for Juniper's product candidates and IVR technology
platform, statements relating to the advancement of Juniper's
product candidates, including a potential IND and IND-enabling
activities for JNP-0201 and potential partnering agreements for
these product candidates, statements concerning the successful
negotiation and completion of an extension of the
CRINONE® supply agreement with Merck KGaA
and statements relating to the ability to continue to grow
the JPS business, the strength of Juniper's core business, product
candidates and future results. 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 potential employee
retention challenges following our restructuring; risks associated
with the drug development process generally, including the outcomes
of planned clinical trials and the regulatory review process; 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, particularly with respect to JPS and CRINONE®.
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 for the period ended
December 31, 2016 and subsequent
filings with the SEC. 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:
Argot Partners
Laura Perry or Heather Savelle
212-600-1902
laura@argotpartners.com
heather@argotpartners.com
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SOURCE Juniper Pharmaceuticals, Inc.