Columbia Laboratories, Inc. is a specialty pharmaceutical company developing products that utilize our bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner.
Columbia has developed and sold six products for the U.S. market, including the following:
CRINONE® (progesterone gel) is a sustained-release bioadhesive progesterone gel. It is applied into the vagina using a pre-filled, tampon-like applicator. The gel adheres to the vaginal walls, enabling the natural progesterone to be absorbed directly where it is needed.
Columbia sold U.S. rights to CRINONE to Watson Pharmaceuticals in July 2010. Columbia supplies progesterone products to Watson at our direct manufacturing cost plus 10%, and receives a royalty on Watson's annual net sales of the product.
Merck Serono holds foreign rights to CRINONE, and markets CRINONE in over 60 countries. Columbia receives (country by country) the greater of 30% of the net selling price or our direct manufacturing cost plus 20%; gross margin on product sales to Merck Serono is about 40%.
Columbia submitted a new drug application (NDA 22-139) to the FDA in April 2011 for progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. 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. Columbia transferred NDA 22-139 to Watson Pharmaceuticals on February 10, 2012; Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to this application.
On February 24, 2012, Watson received a complete response letter from the FDA. The complete response letter stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at ≤ 32 6/7 weeks gestation (p=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial. Although not part of the requirements communicated to the sponsor during pre-Phase III meetings, the FDA also raised the issue of robustness in efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial. In the complete response letter, FDA stated that additional clinical work would be required to support the approval. Watson is in discussions with FDA regarding a potential pathway to approval for this application.
The investigational preterm birth indication holds significant upside potential for Columbia. If approved, the Company would receive a $30 million milestone payment from Watson on the US commercial launch and receive royalties on annual net sales for the new indication in addition to those for infertility and secondary amenorrhea.
STRIANT® (testosterone buccal system) is approved to treat hypogonadism in men. Columbia sold U.S. rights to STRIANT to Actient Pharmaceuticals in April 2011. The Urology Company markets STRIANT in the UK and certain other European countries; Invaron Pharmaceuticals holds trademark and marketing rights to STRIANT in Canada. Other regions are available for license.
