Juniper Pharma Adds Three New Products to Its Proprietary Pipeline

Juniper Pharmaceuticals, Inc. recently 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 IIb trial is currently enrolling female patients, and results from this clinical trial are expected in mid-2016.

“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,” said Frank Condella, the company’s Chief Executive Officer.

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.

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. In 2014, the US OAB market was estimated to be $1.3 billion, composed of branded and generic products. More than 70% of women discontinue first line treatments within the first year due to adverse events or inadequate efficacy.

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 application to the FDA and initiate clinical studies with JNP-0101 in the second half of 2016.

Approximately 45 million American women are menopausal or approaching menopause. In 2014, the US Hormone Replacement Therapy (HRT) market was estimated at $2.2 billion. 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.

Preterm birth is a significant public health issue, with an estimated 1.3 million women in the US at risk for preterm birth due to short cervical length (SCL). Clinical data supports the use of vaginal progesterone to prevent preterm birth. 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.

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 US 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. For more information, visit www.juniperpharma.com.