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COLUMBIA LABORATORIES, INC.  is a specialty pharmaceutical company focused on women’s reproductive health. Our bioadhesive products and candidates deliver each active drug compound in a controlled, sustained manner.

We promote CRINONE® 8% progesterone vaginal gel for infertility and pregnancy support and STRIANT® for hypogonadism in men.

We commercialize our products outside the U.S. and in domestic markets that fall outside our focus through marketing partners which include Mipharm S.p.A., and Merck Serono.

 

 

INVESTMENT HIGHLIGHTS

  • Solid growth opportunity for CRINONE® 8% in the $300 million U.S. infertility market
  • Increase infertility market penetration by converting users of IM progesterone and compounded vaginal suppositories to CRINONE® 8%.
  • Expand use of CRINONE® 8% to optimize clomiphene citrate cycles.
  • Increase CRINONE® 8% for first trimester pregnancy support.
  • Potential $1.7 billion market opportunity for PROCHIEVE® 8% in preterm birth/short cervix indication
  • Phase III PREGNANT Study underway with NIH Participation: PROCHIEVE® 8% to reduce the risk of preterm birth in women with a short cervix as measured by transvaginal ultrasound at mid-pregnancy.
  • Results expected in the second half of 2010; potential launch in 2011.

MARKETED PRODUCTS

CRINONE® 8% (progesterone gel) is a sustained-release bioadhesive progesterone gel indicated for progesterone supplementation or replacement as part of an assisted reproductive technology treatment for infertile women with progesterone deficiency. CRINONE® 8% 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.

We promote CRINONE® 8% in the U.S.; Merck Serono holds foreign rights to CRINONE® 8% and markets CRINONE® 8% in 56 countries. The product is also available in the U.S. under a second brand name, PROCHIEVE® 8% (progesterone gel).

Four presentations of ground-breaking new data from three clinical trials evaluating CRINONE® 8% were given at the 2009 annual meeting of the American Society of Reproductive Medicine. Notably, the largest prospective, randomized clinical study to compare vaginal progesterone to IM progesterone for luteal support in infertility treatment found CRINONE 8% was equally effective and significantly better tolerated than IM progesterone. Find additional information on crinoneusa.com.

We promote STRIANT® (testosterone buccal system) to treat hypogonadism in men in the U.S. Mipharm S.p.A. manufactures and sells STRIANT® in Italy, and the Urology Company will market Striant in the UK. The rest of the world is available for sub-license. Find additional information on striant.com.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.