BOSTON, Feb. 26, 2015 /PRNewswire/ -- Columbia Laboratories, Inc. (Nasdaq: CBRX) (“Columbia” or “the Company”), a specialty pharmaceutical company focused on the development of pharmaceuticals for women’s health, plans to initiate a Phase II clinical trial for COL-1077, a lidocaine bioadhesive 10% gel, in women undergoing transvaginal pipelle-directed endometrial biopsy in the second quarter of 2015. This is following pre-Investigational New Drug (“IND”) submission feedback from the United States Food and Drug Administration (“FDA”).
COL-1077 is being developed as a sustained-release lidocaine gel for vaginal administration, intended as an acute-use anesthetic during minimally invasive gynecologic procedures. Approximately five million gynecological procedures are performed in the U.S. annually, representing a significant need for a safe and effective localized pain treatment for women undergoing these procedures.
The FDA feedback provided guidance on the proposed clinical plan, manufacturing approach, and clinical study design and Columbia is on track to submit its IND application this March.
The Company expects to commence a Phase II clinical trial in the second quarter of 2015. This trial will be a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of a single dose of COL-1077 in women undergoing transvaginal pipelle-directed endometrial biopsy. Clinical trial supplies for the Phase II trial will be produced at the Company’s Nottingham facility.
“The FDA’s feedback on COL-1077 is a critical next step in the advancement of this program to address an unmet medical need in women’s health. Based on data from previous clinical studies, along with this FDA guidance, we believe that COL-1077 is well-positioned to immediately and successfully transition into the clinic,” said Frank Condella, President and Chief Executive Officer of Columbia Laboratories.
Columbia is focused on the development of specialty pharmaceuticals for women’s health, building on the global CRINONE® franchise. The Company’s product pipeline will leverage the 505(b)2 regulatory pathway, when possible, with new formulations of existing pharmaceuticals. With funding from operating cash flows, and internal expertise in formulation and pharmaceutical development, Columbia’s strategy is to advance product candidates through Phase II proof-of-concept and selectively partner for later stage clinical trials and commercialization.
Columbia is actively evaluating new product opportunities for advancement into development. Additional programs will be announced as they clear internal development hurdles, including intellectual property filings, commercial assessments, and clinical development plans.
About Columbia Laboratories
Columbia Laboratories, Inc. has a successful heritage in developing women’s health focused pharmaceutical products, including CRINONE® 8% (progesterone gel), that is marketed by Actavis, Inc. in the U.S. and by Merck Serono S.A. in over 60 additional countries worldwide. Columbia is leveraging its pharmaceutical development, clinical trial manufacturing, and advanced analytical and consulting services to advance an internal pipeline while generating revenue from pharmaceutical industry customers. For more information, please visit www.columbialabs.com.
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 Columbia 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 Columbia’s forward-looking statements, please review Columbia’s reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2013.
Contact:
Katja Buhrer
MBS Value Partners
(212) 661-7004
katja.buhrer@mbsvalue.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/columbia-laboratories-to-initiate-a-phase-ii-clinical-trial-for-col-1077-lidocaine-bioadhesive-10-gel-in-the-second-quarter-of-2015-300041867.html
SOURCE Columbia Laboratories, Inc.
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