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.
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
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
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
About JNP-0301 Progesterone IVR
Preterm birth is a significant public health issue, with an estimated 1.3 million women in
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
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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
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2 Stewart WF, et al., Prevalence and burden of overactive bladder in
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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
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.
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