|Columbia Laboratories' upcoming decision has speculators buying despite bearish sentiment|
|By Brian Wilson|
|Thursday, 16 February 2012 23:09|
After reviewing the data, the panel ended up discouraging approval in late January. It was determined to be safe to the patients who were administered the treatment, but there was no conclusive evidence that worked in favor of Prochieve in the clinical trials. While the final decision by the FDA isn’t entirely dictated by the advisory panel’s evaluation, the bet is extremely lopsided in favor of those betting against an acceptance of Procheive’s NDA. This accounts for the stock’s ~70% decline in reaction to the news, and strong bearish warnings from many analysts covering the company.
As if the high probability of an NDA rejection on February 26th wasn’t bad enough, investor lawsuits have been piling up due to the company’s misleading statements about Prochieve’s efficacy in preventing preterm birth in women. Since litigation fees can be unpredictable, it can be inferred that only the most speculative of biotech investors will want to touch the stock for quite some time. Naturally, an unexpected FDA approval on February 26th would send shares significantly higher.
Snapshot: CBRX is focused on developing product candidates that utilizes its novel bioadhesive drug delivery system (BDS) technologies to optimize drug delivery in a controlled, sustained manner until it is discharged upon normal cell turnover. This occurs every three to five days for the vaginal epithelium and up to every 24 hours for the oral mucosa. The key ingredient in the BDS is polycarbophil, a non-immunogenic, hypo-allergenic, bioadhesive polymer. The company's technology is being used to develop bioadhesive, vaginally-administered anesthetic, testosterone, and carbamide peroxide products to treat a variety of women's healthcare indications. The company's bioadhesive vaginal gels are self-administered using a patient-friendly, pre-filled applicator. Its buccal delivery system technology is utilized to deliver testosterone to men with hypogonadism.
Columbia Laboratories is advancing a diversified portfolio of products for women's healthcare and endocrinological conditions. The company's pipeline products include: Crinone® 8%/Prochieve® 8% (progesterone gel), which is used to reduce risk of preterm birth in women with a short cervix in mid-pregnancy; Crinone® 4% (progesterone gel) - a sustained-release bioadhesive progesterone gel for the treatment of secondary amenorrhea; etc. The company has bioadhesive vaginal products for the over-the-counter market, including: Replens® long-lasting feminine moisturizer and RepHresh® vaginal gel personal lubricant for feminine odor. Its men's health product, STRIANT® (testosterone buccal system) is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (primary or secondary hypogandism).