BOSTON, Jan. 26, 2017 /PRNewswire/ -- Juniper Pharmaceuticals (Nasdaq: JNP) ("Juniper" or the "Company") a women's health therapeutics company, today presented data from a study exploring current practices among U.S. obstetricians to screen, define, and treat a short cervix to prevent preterm birth (PTB) at the Society of Maternal-Fetal Medicine (SMFM)'s 37th Annual Pregnancy Meeting.
Data presented in the poster, titled"Assessing screening and treatment patterns for short cervical length (SCL) in pregnancy" (Program ID No. 403), describe the practice among a balanced sample of physicians across nine geographic regions in the U.S. Of the 500 participating physicians, 91 percent were OB/GYNs, gynecologists, or obstetricians; 6 percent were maternal-fetal medicine specialists; 3 percent were other specialty physicians. All participants were 25 years of age or older with primary practices in the U.S. who actively see adult pregnant patients with a mid-trimester diagnosis of SCL.
For pregnant women with sonographic short cervix and no history of spontaneous PTB, U.S. clinical guidelines recommend use of vaginal progesteronei,ii. However, there are no vaginal progesterone products approved by the U.S. Food and Drug Administration (FDA) that are indicated to treat women with SCL. As a result, the guidelines do not specify a specific progesterone product or dose level to be used.
SCL is a strong predictor of PTB, and PTB is a major contributor to infant mortality in the U.S. The estimated prevalence of pregnant women with SCL less than or equal to 25mm is approximately 400,000.iii
"This study offers us valuable insight on how physicians are combatting preterm birth in their practices, and demonstrates that greater access to an optimized vaginal progesterone therapy to treat women with short cervical length to prevent preterm birth is needed," said Sonia S. Hassan, MD, associate dean of Maternal, Perinatal and Child Health at Wayne State University School of Medicine and co-author of this study.
Juniper is developing an investigational progesterone intravaginal ring, JNP-0301, for sustained delivery of natural progesterone to treat women with SCL who are at risk of delivering before 37 weeks gestation. Prototype formulation development is underway, with definitive sheep studies to be initiated by the end of 2017. An Investigational New Drug (IND) submission is planned for the first half of 2018.
The poster is now available online. The related abstract is included in Society for Maternal-Fetal Medicine: 2017 37th Annual Meeting: The Pregnancy Meeting.
Researchers from Wayne State University and Thomas Jefferson University were involved in the study, which was funded by Juniper Pharmaceuticals.
About Short Cervical Length in Pregnancy
The cervix is a cylinder-shaped neck of tissue that connects the vagina and uterus. Located at the lowermost portion of the uterus, the cervix is composed primarily of fibromuscular tissue. As pregnancy advances, the cervix progressively shortens and thins to permit birth.
In a typical pregnancy, the average cervical length at 24 weeks gestation is 3.5 cm. A short cervical length at mid-pregnancy is the strongest indicator of a pregnant woman's risk of preterm birth. When cervical length is less than 22mm, women face a 20 percent probability of preterm deliveryiii.
SMFM recommends screening women with no history of prior spontaneous preterm birth for short cervical length at 18 to 24 weeks gestation. In women with singleton gestations, no prior history of PTB, and cervical length measuring less than or equal to 20mm at or before 24 weeks gestation, SMFM advocates daily administration of vaginal progesterone from time of diagnosis to 36 weeks gestationi.
There are no FDA-approved drugs, vaginal progesterone or otherwise, to treat women at risk of preterm birth due to short cervical length.
About Preterm Birth
Preterm birth is defined as delivery before 37 weeks gestation. Globally, 15 million babies are born prematurely each year, and approximately one million die as a result of preterm birth complications. The average medical cost for a premature baby is over $50,000, more than ten times that of a healthy infant.
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 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 the anticipated clinical program for JNP-0301, the expected timing of planned IND-enabling sheep studies, the potential timing of an IND submission for JNP-0301, Juniper's ability to leverage the 505(b)(2) pathway for product candidates and the expectation that the core operating business will enable targeted product development investments. 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 formulation development efforts and planned IND-enabling and sheep studies and whether they support further development of JNP-0301 or our other product candidates; risks associated with the regulatory review process, including the risk that the FDA does not ultimately accept our proposed clinical program for JNP-0301; 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. 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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Tell Med Strategies
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Wayne State University School of Medicine
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i Society for Maternal-Fetal Medicine. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol, Volume 206, Issue 5, 376 – 386.
ii American Congress of Obstetrics and Gynecology. Practice Bulletin No. 130: Prediction and Prevention of Preterm Birth Obstet Gynecol 2012;120: 964–73. Affirmed 2016.
iii Iams JD, Goldenberg RL, et al. The length of the cervix and the risk of spontaneous premature delivery. N Engl J Med, 1996; 334: 567–572.
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SOURCE Juniper Pharmaceuticals, Inc.