BOSTON and NEW YORK, Nov. 13, 2015 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), announced details of its portfolio pipeline, focused on three new product candidates to treat women's health conditions, at its Investor Day Wednesday.
The three new product candidates utilize the Company's proprietary multi-segment intra-vaginal ring (IVR):
- JNP-0101, an oxybutynin IVR for the treatment of overactive bladder;
- JNP-0201, a combination IVR delivering estrogen and progesterone hormone replacement therapy (HRT); and,
- JNP-0301, a progesterone IVR for the prevention of preterm birth.
The new IVR product candidates complement COL-1077, the Company's sustained-release 10% lidocaine bioadhesive gel intended for the treatment of gynecologic procedure-related pain. A Phase 2b trial is currently enrolling female patients and results from this clinical trial are expected in mid-2016.
Frank Condella, the Company's Chief Executive Officer, stated, "We are very pleased to announce the advancement of these new product candidates. They represent significant potential commercial opportunities for Juniper in the United States and globally."
Summaries of the IVR product candidates and their target indications follow. For more detailed information, please access the replay of the Investor Day webcast at www.juniperpharma.com or click here. The archived webcast will be available for 90 days.
About JNP-0101 Oxybutynin IVR
Overactive bladder (OAB) is a widespread, chronic condition caused by involuntary contraction of the detrusor muscles before the bladder is full. OAB affects approximately 20 million women in the United States, with an estimated nine million receiving pharmacotherapy to treat the condition.1,2,3 In 2014, the U.S. OAB market was estimated to be $1.3 billion, comprised of branded and generic products. 4 More than 70% of women discontinue first line treatments within the first year due to adverse events or inadequate efficacy.5,6,7,8
Juniper's oxybutynin IVR has the potential to address the most pressing unmet needs in the market by offering more localized absorption, reduced side effects and sustainable delivery. Juniper plans to submit an Investigational New Drug ("IND") application to the FDA and initiate clinical studies with JNP-0101 in the second half of 2016.
About JNP-0201 Estrogen + Progesterone IVR
Approximately 45 million American women are menopausal or approaching menopause.9 In 2014, the U.S. Hormone Replacement Therapy (HRT) market was estimated at $2.2 billion.10 Juniper's combination estrogen and progesterone IVR candidate has the potential to offer patients multiple benefits as compared with currently available therapies, including: integrated administration of natural progesterone and estrogen; improved patient compliance; improved side effect profile; and vaginal delivery of natural hormones, while eliminating the need for daily administration.
About JNP-0301 Progesterone IVR
Preterm birth is a significant public health issue, with an estimated 1.3 million women in the United States at risk for preterm birth due to short cervical length ("SCL").11 Clinical data supports the use of vaginal progesterone to prevent preterm birth.12,13,14 Despite the medical need and cost savings associated with prevention of preterm birth, no products are FDA approved to prevent preterm birth in women at risk due to a short cervix.
Juniper's progesterone IVR may offer meaningful benefits to women with SCL. By providing continuous, consistent, local delivery of natural progesterone, this product candidate may increase patient compliance as compared to current off-label progestogens, which require daily administration, thereby potentially improving overall outcomes. Juniper expects JNP-0301 development will be facilitated by development of JNP-0201 for HRT.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. is focused on developing therapeutics that address unmet medical needs in women's health. Juniper has a commercial product, CRINONE® 8% (progesterone gel), which is marketed by Allergan, Inc. in the U.S. and by Merck KGaA, Darmstadt, Germany, in over 90 countries worldwide. The Company is advancing a pipeline of proprietary drug candidates leveraging novel delivery technologies. 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 Allergan, Inc. in the U.S. and of Merck KGaA, Darmstadt, Germany, outside the U.S.
Forward Looking Statements
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are usually indicated by the words "may," "will," "plans," "believes," "expects," "anticipates," "potential," "should," or similar expressions, and which are generally not historical in nature. These include all statements relating to expected product development and the timing thereof; potential benefits of Juniper's product candidates; and. 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. 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. 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, 2014 and 10-Q for the period ended September 30, 2015.
Amy Raskopf Director, Corporate Communications Juniper Pharmaceuticals (917) 673-5775 email@example.com
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1 Milsom I, et al., How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001; 87(9): 760-6. 2 Stewart WF, et al., Prevalence and burden of overactive bladder in the United States. World J Urol. 2003; 20(6): 327-36. 3 Griebling, TL, et al., Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJUI. 2011; 108(7): 1132-8. 4 Technavio Insights, 2014. Global Overactive Bladder Therapeutics Market Report. Available from http://www.technavio.com/report/global-overactive-bladder-therapeutics-market-2014-2018 5 Yu YF, et al., Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid program. Value Health. 2005; 8: 495–505. 6 Shaya FT, et al., Persistence with overactive bladder pharmacotherapy in a Medicaid population. Am J Manag Care. 2005; 11(4 Suppl): S121–9. 7 Gopal M, et al., Discontinuation rates of anticholinergic medications used for the treatment of lower urinary tract symptoms. Obstet Gynecol. 2008; 112: 1311–8. 8 Krhut J, et al., Persistence with first line anticholinergic medication in treatment-naïve overactive bladder patients. Scand J Urol. 2014; 48: 79–83. 9 U.S. Census Bureau, Population Division. Table 2. Projections of the Population by Selected Age Groups and Sex for the United States: 2015 to 2060 (NP2012-T2). Release date: December 2012. 10 Symphony Health Solutions Report. 11 Estimated based on Iams JD et al. N Engl J Med. 1996;334(9): 567-572 12 Fonseca EB et al., Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. 13 Hassan SS et al., Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15. 14 Maher MA et al., Prevention of preterm birth: a randomized trial of vaginal compared with intramuscular progesterone. Acta Obstet Gynecol Scand 2012; 91:DOI: 10.1111/aogs.12017.
SOURCE Juniper Pharmaceuticals, Inc.