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Juniper Pharmaceuticals Announces Publication of Phase 1 Study Demonstrating Ability of Its Proprietary Intravaginal Ring to Deliver Large Molecules
- Successfully demonstrates ability of an intravaginal ring to deliver leuprolide -
- Juniper IVR technology unique among intravaginal rings -

BOSTON, May 5, 2016 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a women's health therapeutics company, today announced that the Journal of Controlled Release has published the results of the first proof of concept study to explore the ability of Juniper's intravaginal ring ("IVR") to successfully deliver larger molecules, including peptides and proteins. The article reports that the unique technology of Juniper's IVR differs from all of the five commercially available transvaginal rings. The abstract is available online at http://www.ncbi.nlm.nih.gov/pubmed/27130696.  The Journal of Controlled Release has a current impact factor of 7.633, making it one of the most influential journals in the pharmaceutics, biomaterials, and drug delivery fields.

Juniper Pharmaceuticals, Inc. (PRNewsFoto/Juniper Pharmaceuticals, Inc.)

"Therapies based on peptides are notoriously difficult to deliver and typically cannot be taken orally," said principal investigator Alexa B. Kimball, MD, MPH, Massachusetts General Hospital and Harvard Medical School.  "This study demonstrates the potential of a new delivery route for peptide therapeutics for women. To further explore transvaginal absorption capabilities, future studies will need to examine larger molecules and the administration of these molecules for longer periods of time and in larger numbers of women."

The publication, "A novel approach to administration of peptides in women: Systemic absorption of a GnRH agonist via transvaginal ring delivery system," explored the ability of Juniper's IVR to deliver the nine amino acid peptide leuprolide, a Gonadotropin Releasing Hormone agonist (GnRHa) which is sold commercially as an injectable under the brand names Eligard and Lupron for the treatment of precocious puberty, prostate cancer, infertility, fibroids, and endometriosis.

In this clinical trial, six normal healthy female volunteers underwent administration of 18 or 36mg of leuprolide via Juniper's novel ethylene vinyl acetate intravaginal ring drug delivery system. Consistent with the biologic activity representative of the leuprolide entering the circulation, serum levels rose within eight hours following insertion and was dose dependent.  GnRHa biological activity was validated by secretion of gonadotropins and sex steroids.

These results demonstrate that the non-keratinized vaginal epithelium permits a rapid absorption of a biologically active peptide, and that there is significant potential for a novel transvaginal drug delivery system to deliver peptides and possibly other macromolecules, such as proteins, CRISPR therapeutics, siRNA, mRNA, monoclonal antibodies, therapeutically.

"A self-administered vaginal ring provides patients with a simplified drug delivery system and should improve compliance and therefore treatment effectiveness," said Bridget A. Martell, MA, MD, Chief Medical Officer of Juniper Pharmaceuticals.

Co-authors of the paper include renowned scientists Robert Langer, ScD, from the Massachusetts Institute of Technology, William F. Crowley, MD, from Massachusetts General Hospital and Harvard Medical School, and Eyal S. Ron, PhD, who is now chief technology officer of Gelesis; each contributed to the development of the technology. 

Peptides cannot typically be given orally because they are broken down in the stomach before they are readily absorbed. While the skin is an attractive way to deliver medications, its superb intrinsic barrier function often makes this route untenable, especially for larger peptides and proteins, and can be a barrier to compliance for some patients since transdermal patches need to be changed more than once weekly. The vaginal epithelium, in contrast, is not keratinized and can allow absorption of other molecules. Juniper's IVR technology also allows sustained delivery over time—from weeks to months.  In addition, this vaginal ring can hold one to two orders of magnitude more drug than transdermal patches, greatly expanding the number and types of drugs that can be delivered and extending the duration of use from a single dose.

About Juniper's Intravaginal Ring

Juniper Pharmaceuticals' novel intravaginal ring ("IVR") technology leverages a pathway unique to women, the highly-vascular and non-keratinized tissue of the vaginal wall.  Due to its unique polymer composition and segmentation capability, Juniper's IVR is the only single ring that has the ability to allow dosing of small and large molecular weights of multiple drugs at multiple release rates, and multiple dosages. The IVR technology allows delivery of a range molecules of various molecular weights including lipophilic and lipophobic molecules, which may offer the opportunity for this delivery system to be used for a range of therapeutics. The Company expects to file an Investigational New Drug ("IND") application for JNP-0101, its oxybutynin IVR candidate to treat overactive bladder in women, in the second half of 2016.

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 novel intravaginal drug delivery technologies.  Juniper's commercial product, CRINONE® 8% (progesterone gel), is marketed by Merck KGaA, Darmstadt, Germany, in over 90 countries worldwide and by Allergan, Inc. in the U.S. 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, Inc. 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 potential utility of the IVR to deliver peptides beyond leuprolide and other larger molecular weight molecules. 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 outcomes of planned clinical trials and the regulatory review process; 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 for the period ended December 31, 2015. 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. 

Contact
Amy Raskopf
Director, Corporate Communications, Juniper Pharmaceuticals, Inc.
(917) 673-5775 / ir@juniperpharma.com

Media:
Amy Covino
Tell Med Strategies
(201) 774-3111 / amy.covino@tmstrat.com

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Citation for this article: Kimball ABet al. A novel approach to administration of peptides in women: Systemic absorption of a GnRH agonist via transvaginal ring delivery system. J Control Release. 2016 Apr 26. pii: S0168-3659(16)30249-8. doi: 10.1016/j.jconrel.2016.04.035. [Epub ahead of print]

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