This technology was developed by renowned scientists Dr.
"This technology affords the opportunity to expand intra-vaginal delivery of drugs to include larger molecules, such as peptides, alone and in combination," said Dr.
"A self-administered vaginal ring provides patients with a simplified drug delivery system and should improve compliance and therefore treatment effectiveness," said Dr.
Currently available IVRs have simplified the delivery of medicine and are convenient and discrete however, few diseases or conditions have been addressed due to technological limitations. Challenges include drug solubility, molecular characteristics and desired controlled release profiles.
Due to its unique polymer composition and segmentation capability, the segmented IVR developed by Drs. Crowley and Langer has the ability to deliver drugs at different dosages and release rates within a single ring system. Drugs such as progesterone and leuprolide have already been tested using the technology and demonstrated sustained release for up to three weeks. The Company has identified a number of product concepts that could address large market segments and will be prioritizing development of the first candidates in the coming months.
"This novel drug delivery technology aligns perfectly with our strategy to develop proprietary products targeting areas of unmet medical need in women, and we see numerous new product and life cycle management opportunities for it," said
Columbia has agreed to minimum annual expenditures to develop products using the vaginal ring technology, and will make milestone-based payments to MGH/
Columbia is funding its proprietary product development program with operating cash flows driven by the global CRINONE® (progesterone gel) franchise and its pharmaceutical services business. The Company intends to advance product candidates through to Phase II proof-of-concept and will look to partner for later stage clinical trials and commercialization.
Recently, the Company announced plans to initiate a Phase II clinical trial for COL-1077 in women undergoing transvaginal pipelle-directed endometrial biopsy in the second quarter of 2015. COL-1077 is being developed as a sustained-release 10% lidocaine gel for vaginal administration, intended as an acute-use anesthetic for minimally invasive gynecologic procedures. Columbia is actively evaluating new product opportunities for advancement into development using this delivery platform as well. Additional programs will be announced as they clear internal development hurdles, including intellectual property filings, commercial assessments, and clinical development plans.
CRINONE® is a registered trademark of
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