Summary
- Company - Columbia Laboratories (CBRX)
- Drug candidate - PROCHIEVE® (progesterone gel)
- FDA Panel - 2012/01/20
- PDUFA - 2012/02/26
Columbia's lead clinical development program is PROCHIEVE® (progesterone gel) to reduce the risk of preterm birth in women with premature cervical shortening. Preterm birth is a serious public health problem, affecting 10 to 12% of all pregnancies in the United States. The ecomomic impact of preterm birth is significant, costing more than $26 billion annually, with the average preterm infant costing approximately $52,000. A short cervical length at mid-pregnancy is the single most powerful predictor of preterm birth.
Technology
Key Ingredient
Each of Columbia’s marketed products and product candidates utilizes its bioadhesive drug delivery system (BDS) technology that differentiates Columbia from its competitors and provides a platform for numerous future applications. The key ingredient in the BDS is polycarbophil, a non-immunogenic, hypo-allergenic, bioadhesive polymer. Polycarbophil bonds to the cells of the body’s mucosal surfaces upon administration. In Columbia's vaginally-administered products, it bonds to the vaginal epithelial cells. Once in place, the BDS releases the active drug in a controlled and sustained manner until it is discharged
upon normal cell turnover. This occurs every three to five days for the vaginal epithelium.
upon normal cell turnover. This occurs every three to five days for the vaginal epithelium.
Formulation
Gels —The Company’s bioadhesive vaginal gels are self-administered using a patient-
friendly, pre-filled applicator.
friendly, pre-filled applicator.
Chemistry
Polycarbophil is lightly cross-linked with divinyl glycol. It is a weak polyacrylic acid (pKa = 4.2) containing multiple carboxyl radicals (COO-), which are the source of its negative charges. These acid radicals permit hydrogen bonding with the cell surface. Hydrogen bonds are weak, but in the case of polycarbophil they are numerous and therefore tenacious.
Polycarbophil mimics negatively charged mucin, the glycoprotein component of mucus responsible for its attachment to underlying epithelial surfaces.
Benefits
Bioadhesive vaginal delivery of progesterone exhibits the following benefits:
Bioadhesive vaginal delivery of progesterone exhibits the following benefits:
- Facilitates targeted delivery of active compounds to the uterus, right where they are needed
- Avoids the local site pain, irritation and potential infection of daily compounded progesterone intramuscular injections
- Maintains low systemic levels
Pre-filled applicators make these FDA-approved products easy to use and patient-friendly, without the mess of pharmacy-compounded suppositories.
Columbia’s technology is currently being used to develop bioadhesive, vaginally-administered anesthetic, testosterone, and carbamide peroxide products to treat a variety of women’s healthcare indications.
Summary of Clinical Data
In April 2007, Columbia reported that data from a Phase III clinical trial that evaluated PROCHIEVE for the prevention of preterm birth in women with a prior preterm birth earlier than 35 weeks show a delay in cervical shortening in patients treated with PROCHIEVE versus placebo. The data further suggest a correlation between cervical length, progesterone administration, and both a reduction in the likelihood of preterm birth and an improvement in infant outcomes. The data were published in the peer-reviewed journal Ultrasound in Obstetrics & Gynecology in October 2007.
In 2008, Columbia initiated the PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) study, a randomized, double-blind, placebo-controlled Phase III clinical trial evaluating PROCHIEVE to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound at mid-pregnancy. In October 2008, Columbia announced a collaboration with the Perinatology Research Branch (PRB) of the Division of Intramural Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), under which we amended the study protocol to reflect the addition of nine NIH sponsored sites and an increase in the number of patients from 300 to 450.
In December 2010, Columbia and Watson jointly reported positive top-line PREGNANT study results; the study was published in Ultrasound in Obstetrics & Gynecology in July 2011. The published results indicate that administration of PROCHIEVE from mid-pregnancy until term in women with a premature cervical shortening as confirmed by transvaginal ultrasound was associated with a statistically significant reduction in the rate of preterm birth at ≤32 6/7 weeks (p=0.020), the primary endpoint of the study, vs. placebo gel. Use of PROCHIEVE was associated with a 45% reduction in the incidence of preterm birth at this endpoint. Improvement in infant outcome was noted with PROCHIEVE. The incidence and profile of adverse events in patients receiving PROCHIEVE was comparable to placebo, which was as expected given the product's documented safety history.
In 2008, Columbia initiated the PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) study, a randomized, double-blind, placebo-controlled Phase III clinical trial evaluating PROCHIEVE to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound at mid-pregnancy. In October 2008, Columbia announced a collaboration with the Perinatology Research Branch (PRB) of the Division of Intramural Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), under which we amended the study protocol to reflect the addition of nine NIH sponsored sites and an increase in the number of patients from 300 to 450.
In December 2010, Columbia and Watson jointly reported positive top-line PREGNANT study results; the study was published in Ultrasound in Obstetrics & Gynecology in July 2011. The published results indicate that administration of PROCHIEVE from mid-pregnancy until term in women with a premature cervical shortening as confirmed by transvaginal ultrasound was associated with a statistically significant reduction in the rate of preterm birth at ≤32 6/7 weeks (p=0.020), the primary endpoint of the study, vs. placebo gel. Use of PROCHIEVE was associated with a 45% reduction in the incidence of preterm birth at this endpoint. Improvement in infant outcome was noted with PROCHIEVE. The incidence and profile of adverse events in patients receiving PROCHIEVE was comparable to placebo, which was as expected given the product's documented safety history.
Source: Columbia Laboratories
Trading map
For those unfamiliar with the hike-n-slide trading strategy, my primary strategy to trade biotech stocks, it takes advantage of the increased volatility and hyped up anticipation of a pre-scheduled event (i.e., FDA panel, clinical results release, PDUFA). Trades are made before and after the announcement of the event outcome without having to hold unjustifiable risks through the event. As such, the actual outcome of the event (i.e., positive or negative recommendation, approval or rejection) will not significantly affect the profitability of the trades - the beauty of the hike-n-slide trading strategy.
CBRX has climbed more than 15% in the past month ahead of the 1/20 FDA panel as traders broadly anticipate positive recommendations from the panelists. At $2.50, CBRX is still 72.4% lower than its 52-wk high of $4.31, which was seen after a hike in share price that initiated after the company announced positive phase III clinical trial data in Dec of 2010. As the FDA panel date approaches, CBRX is expected to hike back towards this level as trading activity picks up. A great way to trade CBRX is through call options. As of the last trading session of 2011, CBRX Jan 2.5 call was trading at $.30, meaning that the options would be in the money when CBRX trades at $2.8 ($2.5 + $.30). If the global economy remains steady, it is very likely that CBRX will be trading above $2.8 before 1/20. However, the only concern is that Jan call options expire on 1/21, a day after the panel meeting takes place on the Friday before the option expiration (OpEx) weekend. In other words, traders may not have a chance to know the results of panel votes before the options stop trading at the end of Friday's trading. This may encourage more buying of the Feb call options which of course carry a higher time premium. It is ultimately up to the individuals to decide which of the Jan or the Feb call options to go with for trading CBRX. So far, higher volume has been observed with the Jan call options compared to the Feb call options. I will make my call (no pun intended) fairly soon. Follow me on Twitter (@Michaeljuan01) for trading updates. Good luck!
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