Title: "Assessing Screening and Treatment Patterns for Short Cervical
Length (SCL) in Pregnancy" (Program ID No. 403)
The abstract is included in the SMFM Supplement entitled
Data from this study, funded by
The Company is developing JNP-0301 to deliver natural progesterone to treat women with short cervical length who are at risk of delivering before 37 weeks gestation. The constructive pre-IND meeting was the first step towards determining a potential clinical development pathway that could lead to an eventual product approval.
Prototype formulation development is underway, with IND-enabling studies planned for 2017. The Company expects to initiate definitive sheep studies by year-end 2017 which, among other planned activities, could potentially enable an IND submission in the first half of 2018 for JNP-0301.
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 a pregnancy advances, the cervix progressively shortens and thins to permit the infant's 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 2.2 cm, women face a 20 percent probability of preterm delivery1.
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 ≤24 weeks, SMFM advocates daily administration of vaginal progesterone from time of diagnosis to 36 weeks gestation2.
There are currently no
About Preterm Birth
Preterm birth is the delivery before 37 weeks gestation. Globally, 15 million babies are born prematurely each year, and one million will die. The average medical cost for a premature baby is over
About Juniper Pharmaceuticals
Juniper Pharmaceuticals™ is a trademark of
Crinone® is a registered trademark of
1. 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.
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 prototype completion and planned IND-enabling and 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
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