Share Structure: Shares Float 65,050,000 Total Shares Outstanding 65,605,886 % Owned by Insiders 29.07% % Owned by Institutions 9.40% Market Cap. $ 70,395,113 Trading Volume - Today 1,200 Trading Volume - Average 109,800 Trading Volume - Today vs. Average 31.25 % Earnings Per Share -0.46
Pregnant study on PROCHIEVE (progesterone gel) Phase 3 top line results by year end 2010
“Our focus now is completing the PREGNANT Study. We eagerly anticipate reporting top-line results of this pivotal Phase 3 clinical trial, and expect to do so before the end of December. Positive data would trigger a 6 or 8 million dollar milestone payment from Watson and pave the way for an NDA filing in the first half of 2011” Frank Condella, Jr.
"All patients were enrolled at mid-pregnancy, so the last infant could be born as late as mid-November" Top line results will be released 4-6 weeks later.
A few key points:
CRINONE® 8% (progesterone gel) is marketed by Watson Pharmaceuticals in the United States and by Merck Serono in foreign countries.
Columbia is conducting a randomized, double-blind, placebo controlled Phase III clinical program, called the PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study, to evaluate the safety and efficacy of PROCHIEVE 8% (progesterone gel) to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint of this study is a reduction in the incidence of preterm birth at less than or equal to 32 weeks gestation vs. placebo. The Company expects study results before the end of December 2010
In June Columbia Labs announced they signed a $15M term loan with Watson. The proceeds from the loan were intended to be used to finance activities related to PROCHIEVE. If the previously announced definitive agreement for Watson to acquire all of Columbia’s progesterone related assets and 11.2 million shares of common stock closes before the maturity date of the loan, all principal and accrued interest on the loan will be forgiven.
Watson Pharmaceuticals acquired Prochieve from Columbia Labs July 2010
Under the terms of the agreement, Watson paid Columbia an initial $47 million payment for exclusive progesterone gel product rights in the US and received 11,200,000 newly issued shares of Columbia common stock. Another $45.5M can be earned by Columbia for the successful completion of clinical development milestones in the ongoing pregnancy study. Watson also has the right to designate a member to Columbia's board of directors. This forgave all principal and accrued interest from the earlier $15M term loan and reduced Columbia’s debt to ZERO.
Prior to entering into the subordinated term loan with Watson, Columbia received a proposal from another global pharmaceutical company to acquire the assets and shares of Columbia common stock that were the subject of the Watson agreement. Columbia stuck with Watson most likely to negate the first $15M term loan.
Watson will also pay Columbia a royalty on Watson's sales of the progesterone gel product and any next generation products. Columbia is responsible for the anticipated clinical and regulatory costs related to obtaining approval for progesterone gel.
The fact that two companies, Watson, and the other unknown company tried to purchase the rights to PROCHIEVE led me to believe that they might have had some information as to how the trial outcome would play out. So I did some digging on progesterone and found an article in the New England Journal of Medicine titled “ Progesterone and the Risk of Preterm Birth Among Women with a Short Cervix”.
This article is about a trial that took place from September 2003 through May 2006 in 5 maternity hospitals in and around London. Women with a cervical length of 15mm (1.5cm) or less were invited to take part in a randomized, double-blind, placebo controlled trial of progesterone.
The results of this randomized trial demonstrate that in women with a short cervix, the daily vaginal administration of 200 mg of progesterone from 24 to 34 weeks of gestation significantly reduces the rate of spontaneous preterm delivery.
It’s almost identical to Columbia’s Phase 3 trial of Prochieve, AKA Progesterone. So it seems to me that both Watson and Columbia have a very good idea, based on the results from the study in London, that the Phase 3 results will be positive.
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