Columbia Laboratories has a rich heritage in pharmaceutical research and development that has helped place the company on the forefront of women's healthcare and drug delivery. Our products use the principles of bioadhesion to achieve controlled, sustained delivery of hormones and other compounds that are difficult to administer. Commercially available products using our drug delivery technologies include:
Columbia's products have been commercialized through partnerships, and by our own sales force from 2002 until July 2010 when we sold our progesterone assets to Watson Pharmaceuticals. We are now a focused drug development company that enjoys ongoing royalties from our marketing partners. In December 2010, we reported positive top-line results from the PREGNANT study, a large, global Phase III clinical trial evaluating PROCHIEVE® 8% (progesterone gel) for the reduction in the risk of preterm birth in women with premature cervical shortening. The study was published in April 2011 in the Journal of Ultrasound in Obstetrics and Gynecology. Access publication. In April 2011, we submitted an NDA to the FDA for PROCHIEVE for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy; the FDA accepted this NDA for filing. The Advisory Committee for Reproductive Health Drugs of the FDA reviewed this NDA on January 20, 2012. While panel members generally agreed that progesterone vaginal gel 8% is safe, the Committee stated that more information is needed to support approval. Though the FDA will consider recommendations of the Committee, the final decision regarding the approval of the product rests solely with the FDA. Under the Prescription Drug User Fee Act IV (PDUFA), the FDA's goal is to review and act on the NDA by February 26, 2012.
We continue to explore new applications for our drug delivery systems. STRIANT® is a registered trademark of Actient Pharmaceuticals LLC. CRINONE® is a registered trademark of Watson Pharmaceuticals, Inc. Replens® and RepHresh® are registered trademarks of Lil' Drug Store Products, Inc.
