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.

Investment Highlights

  • Strong cash balance; debt free
  • Low operating expenses
  • Revenues include product sales to Watson and Merck Serono, royalties from Watson and STRIANT sales
  • Eligible for up to $45.5 million in milestone payments from Watson for the potential preterm birth/short cervix indication
  • The Company’s New Drug Application (NDA) for PROCHIEVE® (progesterone gel) for preterm birth/short cervix indication was accepted for filing by the Food and Drug Administration (FDA) with a PDUFA date of February 26, 2012.

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.

  • CRINONE 8% is indicated for progesterone supplementation or replacement as part of an assisted reproductive technology treatment for infertile women with progesterone deficiency.
  • CRINONE 4% is indicated for the treatment of secondary amenorrhea.

Columbia sold U.S. rights to CRINONE to Watson Pharmaceuticals in July 2010, 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 submitted an NDA to the FDA in April 2011 for PROCHIEVE® (progesterone gel) 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. Though the FDA will consider recommendations of the Committee, the final decision regarding the approval of the product rests solely with the FDA. The FDA's goal is to review and act on the NDA by February 26, 2012 under the Prescription Drug User Fee Act IV (PDUFA). Columbia sold rights to PROCHIEVE to Watson Pharmaceuticals in July 2010. 

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.

 

Company Headquarters

Columbia Laboratories, Inc.

354 Eisenhower Parkway- Plaza I, 2nd Floor
Livingston, NJ 07039
Phone: (973) 994-3999 - Fax: (973) 994-3001

Investor Contact

Seth Lewis
The Trout Group
Phone: (646) 378-2952


These data are provided as a convenience for stockholders and are for informational purposes only. These data are not intended, and should not be relied upon, for trading purposes. Neither the Company nor its data providers guarantee the accuracy or completeness of any stock price or other data displayed, nor shall any such party be liable in any way to the user of the data or to any other person for any delays, inaccuracies, errors in or omission of any such data or the transmission thereof, or for any actions taken in reliance thereon or for any damages arising there from or occasioned thereby. Investors are reminded that historical and current stock price performance data are not necessarily indicative of future performance.


CRINONE and PROCHIEVE are registered trademarks of Watson Pharmaceuticals, Inc.
STRIANT is a registered trademark of Actient Pharmaceuticals, LLC.