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.
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SOURCE Juniper Pharmaceuticals, Inc.