Columbia Laboratories' upcoming decision has speculators buying despite bearish sentiment Print E-mail
By Brian Wilson   
Thursday, 16 February 2012 23:09
FDA CalendarShare prices have risen slightly during the past three sessions for Columbia Laboratories (CBRX)--  a small pharmaceutical company with a market cap of about 70 million that is focused on developing products that utilize its bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner.


The company which currently sells five products, which include Crione which had its US marketing rights sold to Watson Pharmaceuticals and international rights sold to Merck Serono in 2010. Despite light volume, royalties are enough to keep Columbia EPS positive. {bmrutilty}Investors were blindsided last month (specifically on January 17th) by news from the FDA’s advisory panel which performed a review of the efficacy of Prochieve® progesterone gel. The treatment was supposedly meant to reduce the risk of preterm birth in women that have a short cervix through hormonal controls. The drug has successfully passed through clinical trials, and has a pending NDA which is set to be decided upon on February 26th 2012 under the PDUFA.

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).




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