Under normal conditions, a pregnant women goes into labor when her pregnancy reaches the full term, say 40 weeks. But sometimes a woman goes into labor before 37 weeks of pregnancy - a complicated problem what is called preterm labor resulting in preterm birth. Preterm labor is reported to occur in about 12 percent of all pregnancies in the United States.
Though the exact cause of preterm labor or premature birth still remains a mystery, there are certain factors that increase a woman's risk of having premature labor - with one of them being the length of cervix. For women who have a short cervix, as measured by transvaginal ultrasound at mid-pregnancy, the risk of spontaneous preterm delivery is found to be higher, according to studies.
The first drug to be approved by the FDA to reduce risk of preterm birth is KV Pharmaceutical Co.'s (KV-A) Makena, and it was given the green light for that indication in February of this year.
Awaiting the FDA decision for its investigational product, which is meant to reduce the risk of preterm birth in women with a short cervical length, is Columbia Laboratories Inc. (CBRX). The product under regulatory review is PROCHIEVE 8% vaginal progesterone gel, whose U.S. rights to the product is owned by Watson Pharmaceuticals Inc. (WPI).
In clinical studies, administration of PROCHIEVE 8% vaginal progesterone gel from mid-pregnancy until term in women with a premature cervical shortening was associated with a statistically significant reduction in the rate of preterm birth and improvement in infant outcome compared to placebo gel.
The new drug application for PROCHIEVE 8% vaginal progesterone gel for the reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy was submitted to the FDA on April 26, 2011. The NDA for PROCHIEVE 8% vaginal progesterone gel, which was accepted for review by the regulatory agency in June of this year, has a decision date set for February 26, 2012.
But before the FDA issues its final word on PROCHIEVE 8% vaginal progesterone gel for the proposed indication , the Advisory Committee for Reproductive Health Drugs of the FDA is scheduled to review the NDA on January 20, 2012.
In March of 2010, Columbia Labs signed an agreement with Watson Pharma, a deal valued at $92.5 million, under which Watson Pharma acquired the U.S. rights to PROCHIEVE 8% and another brand of progesterone gel product CRINONE. Columbia received an upfront payment of $47.5 million from Watson Pharma, and in July of this year, received a milestone payment of $5 million, following the FDA's acceptance of the PROCHIEVE NDA filing.
If PROCHIEVE 8% vaginal progesterone gel gets FDA approval for the preterm birth indication, Columbia Labs will receive a $30 million milestone payment from Watson Pharma upon commercial launch of the product in the U.S.
CRINONE, which is also known under the trade name PROCHIEVE, is a sustained release gel that delivers natural progesterone vaginally, that utilizes Columbia Lab's patented Bioadhesive Delivery System, or BDS, and is designed to deliver progesterone directly to the uterus. The product is available in both 4% and 8% concentrations.
CRINONE 8% was approved in the U.S. in 1997 for treatment for infertile women with progesterone deficiency. CRINONE in both the 8% and 4% concentrations is approved in the U.S. for the treatment of secondary amenorrhea (loss of menstrual period). After Watson Pharma assumed responsibility for CRINONE and PROCHIEVE, the distribution of PROCHIEVE for infertility and amenorrhea was discontinued by Watson Pharma in the third quarter of 2010. Outside the U.S., CRINONE is sold by Merck Serono, the biopharmaceutical division of German drugmaker Merck KGaA.
Yet another FDA-approved product of Columbia Labs is Striant, which is prescribed for the treatment of men with a deficiency or absence of testosterone. In the U.S, the product is marketed and sold by Columbia Labs whereas it is sold to The Urology Co. Ltd. for resale in the U.K.
A quick look at Columbia Labs' balance sheet...
The company derives revenue from CRINONE/PROCHIEVE - the BDS "Progesterone Products" that are sold to Watson and Merck Serono for resale, royalties from Watson Pharma and Merck Serono and from sales of Striant and OTC vaginal gel products like Replens and RepHresh.
In the nine months ended September 30, 2011, the company earned $21.5 million or $0.20 per share, compared to a loss of $17 million or $0.24 per share in the year-ago period. The total revenue in the first nine months of 2011 was $36.6 million, up from $30.7 million in the comparable period last year.
At September 30, 2011, Columbia Labs had $26.3 million in cash and zero debt.
Incorporated in 1986, Columbia Labs began trading on the NASDAQ Global Market on February 13, 2004, prior to which it traded on the American Stock Exchange. The company joined the Russell 3000 Index in June of this year.
So far CBRX has hit a 52-week low of $1.55 and 52-week high of $4.31. The stock, which has lost more than 30% in the past six months, closed Tuesday's trading at $2.26.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.