BOSTON /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("the Company"), a specialty pharmaceutical company focused on developing therapeutics that address unmet medical needs in women's health, today announced the creation of a Scientific Advisory Board ("SAB") comprised of internationally renowned physicians and scientists, whose mission will be to provide scientific and clinical advice on the identification and advancement of product candidates for Juniper's women's health portfolio.
The SAB consists of the following distinguished members: Ginger D. Constantine, MD; William F. Crowley Jr., MD; Martyn Davies, BSc, Ph.D., FRPharmS, CChem, FRSC; Robert S. Langer, Sc.D.; and, Daniel A. Shames, MD, FACS.
"We are thrilled to have attracted to our newly-formed SAB such prominent physicians and scientists who share our interest in women's health," said Frank Condella, Chief Executive Officer of Juniper Pharmaceuticals. "This distinguished group will work closely with our management team to identify opportunities of medical need in women's health, prioritize our product development portfolio, and provide strategic advice on clinical program development and appropriate regulatory pathways."
Composition of Juniper Pharmaceuticals' Scientific Advisory Board
Ginger Constantine, MD
During her ten year tenure within the Wyeth Pharmaceuticals and Wyeth Research organizations, Dr. Constantine held various management positions of increasing responsibility in the therapeutic areas of rheumatology, metabolism and bone repair. She ultimately served as Vice President of Women's Health & Bone Repair Medical Research at Wyeth Research until its acquisition by Pfizer in 2010, guiding her staff to the completion of numerous Investigational New Drug Applications and more than ten New Drug Applications and European dossiers in the areas of contraception, osteoporosis, menopausal symptoms, endometriosis, and osteoarthritis. Prior to joining Wyeth, Dr. Constantine was a practicing physician specializing in Rheumatology and Internal Medicine.
William F. Crowley, Jr., MD
Dr. Crowley is the Daniel K. Podolsky Professor of Medicine at Harvard Medical School, where he also serves as the Chief of the Reproductive Endocrine Unit of the Department of Medicine at Massachusetts General Hospital (MGH). In addition, he is the Director of the Harvard-wide Reproductive Endocrine Sciences Center. He served as the Director of Clinical Research for the MGH for 17 years. During this time, Dr. Crowley founded and served as the first Chair of The Clinical Research Forum, a national consortium of the top 60 academic medical centers engaging in clinical and translation research.
Martyn Davies, BSc, Ph.D., FRPharmS, CChem, FRSC
Dr. Davies is Professor of Biomedical Surface Chemistry at the University of Nottingham School of Pharmacy, and has over 30 years' experience in the pharmaceutical, biopharmaceutical and drug delivery fields. Dr. Davies co-founded Juniper Pharma Services in 1997 as a spin-out company from his academic laboratory, and served as its Founder-Chairman until its acquisition by Juniper Pharmaceuticals in September 2013, at which time he was appointed Advisor to the Company's Board of Directors.
Robert S. Langer, Sc.D.
Dr. Langer is the Massachusetts Institute of Technology Department of Chemical Engineering David H. Koch Institute Professor; being an Institute Professor is the highest honor that can be awarded to a faculty member. He is the most cited engineer in history. Dr. Langer served as a member of the United States Food and Drug Administration (FDA) SCIENCE Board, the FDA's highest advisory board, from 1995 until 2002 and as its Chairman from 1999 to 2002. He is one of four living individuals to have received both the United States National Medal of Science (2006) and the United States National Medal of Technology and Innovation (2011). He also received the 2002 Charles Stark Draper Prize, considered the equivalent of the Nobel Prize for engineers.
Daniel A. Shames, MD, FACS
Dr. Shames has extensive experience in pharmaceutical development and regulatory affairs. During his 12-year tenure at the FDA, he served as Deputy Director, Office of Drug Evaluation III/Center for Drug Evaluation and Research (CDER) from 2006 to 2008, and was a member of the senior management team of the Office of New Drugs and the Drug Safety Oversight Board. From 2001 to 2006, he served as Director of the FDA's Division of Reproductive and Urologic Products and reviewed therapeutic products for clinical areas including contraception, infertility, obstetrics, menopause, and urinary incontinence.
The aggregate expertise of the SAB spans multiple areas of direct relevance to the Company's proprietary product development strategy, including drug delivery and biomaterials, innovative engineering, women's health, including reproductive endocrinology, and regulatory affairs.
The SAB will hold its inaugural meeting this week in Boston, and will meet on a regular basis as the Company advances its proprietary product portfolio. Dr. Martyn Davies will serve as Chairman.
"The support of these esteemed scientists underscores the scientific and clinical enthusiasm for our drug development strategy. We expect successful execution of this strategy will materially change the Company's future growth prospects and build long-term shareholder value," Mr. Condella concluded.
Juniper's drug development strategy is to advance novel formulations of previously approved products through proof-of-concept, and then look to partner for late-stage clinical trials and commercialization efforts. The Company focuses on products for women where its novel technologies and in-house capabilities can improve performance and add value, that hold strong intellectual property and other potential barriers to entry, and which utilize the FDA's 505(b)(2) regulatory pathway when possible.
The Company is poised to initiate a Phase II clinical trial of COL-1077 in women undergoing transvaginal pipelle-directed endometrial biopsy this quarter. Formulated with Juniper's proprietary bioadhesive delivery system technology to achieve sustained-release of 10% lidocaine bioadhesive gel, COL-1077 is intended as an acute use anesthetic for minimally invasive gynecologic procedures.
Juniper's patent-protected drug delivery technologies include a segmented intra-vaginal ring ("IVR") that was developed by SAB members Dr. Robert Langer and Dr. William Crowley. Drs. Langer and Crowley also serve as Strategic Advisors to the Company to support the deployment of the IVR technology and guide development of future product candidates.
The IVR technology enables the delivery of one or more pharmaceuticals at different dosages and release rates in a single segmented ring. This patient administered-device will be utilized as a key drug delivery platform for Juniper's emerging proprietary product pipeline.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) (formerly Columbia Laboratories) is a specialty pharmaceutical company focused on developing therapeutics that address unmet medical needs in women's health. Juniper has a successful heritage in developing pharmaceutical products, including CRINONE® 8% (progesterone gel), which is marketed by Actavis, Inc. in the U.S. and by Merck Serono S.A. in over 60 countries worldwide. The Company is uniquely positioned to leverage in-house pharmaceutical development, clinical trial manufacturing, and analytical capabilities to advance an internal development pipeline, while also providing valuable consultative services to its pharmaceutical industry customers. Please visit www.juniperpharma.com for more information.
Juniper Pharmaceuticals™ and Juniper Pharma Services™ are trademarks of Juniper Pharmaceuticals, Inc., in the U.S. and EU.
CRINONE® is a registered trademark of Actavis, Inc. in the U.S.
Forward Looking Statements
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are usually indicated by the words "may," "will," "plans," "believes," "expects," "anticipates," "potential," "should," or similar expressions, and which are generally not historical in nature. These include all statements relating to expected financial performance and future business or product developments. 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. 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. 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.
MBS Value Partners
SOURCE Juniper Pharmaceuticals, Inc.
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