Juniper Pharma Expands Lead Phase 2b Trial, Submits Pre-IND Meeting Request For Its First Intra-Vaginal Ring Product, And Adds Four Key Executives
BOSTON, Jan. 11, 2016 /PRNewswire/ -- Building on its recently disclosed refocus on internal product development, Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or "the Company"), today announced the expansion of its lead clinical trial, and the submission of a pre-IND meeting request with the FDA for its oxybutynin intra-vaginal ring (IVR) for treatment of overactive bladder. The Company also announced the hiring of four new executives to support its future growth.
"Juniper's key product candidates have progressed considerably over the past few months," said Frank Condella, CEO of Juniper Pharmaceuticals. "We continue to expect top-line data from our Phase 2b lidocaine gel trial in mid-2016, and have advanced all three of our recently disclosed intravaginal ring development programs."
"We are well positioned to use our growing cash flow from our base business and strong year end cash position to fully fund our 2016 operations and planned R&D activities internally." Condella continued, "With successful execution of our current operating plans, we expect to launch three new products within the next five years with a combined potential market opportunity well over $1 billion."
Pipeline Update: Bioadhesive Vaginal Gels
COL-1077
The Company's lead candidate, COL-1077, is a 10% lidocaine vaginal gel being developed as an analgesic for gynecologic procedure-related pain. Enrollment is underway in a Phase 2b clinical trial to evaluate the efficacy and safety of a single dose of COL-1077 in women undergoing transvaginal pipelle-directed endometrial biopsy with tenaculum placement.
Driven in part by strong inbound physician interest, Juniper recently expanded this clinical trial to 25 study centers with a planned cohort of up to 185 patients, increasing the power to demonstrate a statistically significant result on both primary and secondary endpoints.
The Company continues to expect study data in mid-2016, with an end of phase 2 regulatory meeting shortly thereafter. Assuming positive outcomes of the Phase 2b clinical trial, Juniper expects to initiate a Phase 3 trial in early 2017. Subject to FDA approval, Juniper expects it would independently commercialize COL-1077 in the United States. The Company is also actively pursuing partnerships for development and commercialization outside of the U.S.
CRINONE
Based on discussions with partner Merck KGaA, Darmstadt, Germany, regulatory approval is anticipated for CRINONE® (progesterone gel) in Japan in 2016.
Intra-Vaginal Rings (IVR)
JNP-0101 Oxybutynin IVR
Juniper has requested a pre-IND meeting with the FDA for JNP-0101, its oxybutynin IVR for the treatment of overactive bladder (OAB) in women. The company currently plans to conduct a Phase 2a bioavailability and dose finding study in the second half of 2016. Assuming positive Phase 2 results, a Phase 3 clinical trial is expected to begin in the first half of 2017. This development program is intended to satisfy the regulatory requirements for approval and will follow the 505(b)(2) regulatory pathway.
JNP-0201 Progesterone/Estrogen IVR
Prototype development is in progress for JNP-0201, a natural estrogen and progesterone product candidate utilizing the multi-segmented capability of Juniper's IVR for hormone replacement therapy (HRT) in women. An IND submission is planned in 2017.
JNP-0301 Progesterone IVR
Juniper intends to meet with the FDA in the first half of 2016 to discuss the regulatory pathway for the development of a vaginal progesterone product candidate for the prevention of preterm birth. Development of the JNP-0301 formulation will benefit from the work being done on JNP-0201.
Industry Leaders Join Management Team
The women's health therapeutics developer recently added four vice presidents to its management team to support the execution of its development programs and continued growth in 2016 and beyond.
Two vice presidents join Chief Medical Officer Bridget A. Martell, MA, M.D. in newly created positions to support the development of proprietary IVR and vaginal gel products: Elaine Richardson and Joyce Pinkham.
Elaine Richardson has joined Juniper as Vice President, Clinical Operations and Data Management, to drive the planning and execution of clinical trials while monitoring all regulatory and quality compliance metrics and requirements. With over twenty-five years of experience in the biopharmaceutical industry, including tenure at Amgen, Forest Research Institute, Pfizer and Searle, Ms. Richardson brings deep experience in management of the clinical operations of global clinical trial activities.
Joyce Pinkham joins Juniper as Vice President, Head of Program and Alliance Management. Ms. Pinkham will be focused on planning and executing Juniper's product development activities from feasibility work through commercialization while exploring innovative approaches to accelerate speed to market, minimize risk, and increase the value of programs. She was most recently Senior Director, Program and Portfolio Management at Cubist Pharmaceuticals, and was previously at Genzyme.
The Juniper business team has also been strengthened with two important new-hires: John Tagliamonte and Joel Dube.
John Tagliamonte has joined as Vice President, Business Development. Most recently Chief Business Officer at Oxyrane, the 20-year biopharmaceuticals industry veteran's prior executive roles include VP Business Development at ImmunoGen and Director, Worldwide Business Development and Licensing, at Johnson & Johnson. Mr. Tagliamonte will oversee Juniper's partnering initiatives for the Company's proprietary segmented IVR and bioadhesive delivery system technologies and product collaborations.
Joel Dube joins as Juniper's Vice President, Finance and Corporate Controller. Most recently Vice President and Corporate Controller at CRA International, where he held increasingly senior positions throughout his eight-year tenure, Mr. Dube is a technical expert in GAAP, SOX, COSO, SEC reporting, management reporting, and financial planning and analysis.
"The appointment of these proven industry leaders reflects our continued drive to build a superior organization in support of our proprietary drug development strategy. We look forward to their contributions as we work to bring new therapeutics to market to better meet women's healthcare needs," Condella concluded.
All four new vice presidents are based at Juniper's Boston, Massachusetts, headquarters; the Company relocated from Liberty Square to 33 Arch Street in December 2015 to accommodate its growth.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. is 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 U.S. 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. 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 Allergan, Inc. in the U.S. and of Merck KGaA, Darmstadt, Germany, outside 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 our anticipated cash flow from operations and our ability to fund 2016 operations and planned R&D activities internally; the timing, statistical power and outcome of clinical trials for Juniper's product candidates; the timing and outcome of regulatory filings and other interactions with the FDA for Juniper's product candidates; and expected contribution of employees. 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, 2014 and 10-Q for the period ended September 30, 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
(917) 673-5775
ir@juniperpharma.com
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SOURCE Juniper Pharmaceuticals, Inc.
