On the heels of promising Phase III results released earlier this year, CollaGenex Pharmaceuticals Inc. decided to move forward in dermatology with its marketed dental product, starting two pivotal trials in rosacea.

The Phase III trials will look at a modified-release formulation of doxycycline, which the company calls Col-101 or Periostat MR. Instead of dosing 20 mg twice a day, the Col-101 product is a 40-mg once-a-day version already in Phase III testing for the adjunctive treatment of adult periodontitis. Periostat dosed at 20 mg twice a day received approval in 1998 for adult periodontitis. CollaGenex is looking for a separate brand name for the product in rosacea.

"There are over 14 million patients that suffer from rosacea and there currently is no approved oral systemic treatment that has been approved by the FDA," said Dave Pfeiffer, the company's senior vice president of sales and marketing.

Pfeiffer declined to say how much the rosacea indication could expand the market for doxycycline, but the company believes the rosacea indication, one of the fastest-growing segments of the U.S. dermatology market, is worth more than $500 million in product sales annually.

CollaGenex does not break down the sales of its products, but it reported about $50 million in 2003 for total sales. Its products include Periostat and other in-licensed products marketed by its dental and dermatology sales forces. The company markets Bad Homburg, Germany-based Altana Inc.'s atopic dermatitis and psoriasis product, Pandel, as well as three dental products belonging to Fort Collins, Colo.-based Atrix Laboratories Inc. - Atridox, Atrisorb FreeFlow and Atrisorb-D.

If all goes well with the Col-101 pivotal trials, CollaGenex expects to file a new drug application within two years.

"We've been saying," Pfeiffer told BioWorld Today, "that we hope the product will be available sometime in the second half of 2006."

The pivotal Phase III studies will each enroll up to 264 patients at a total of 22 centers. Patients will be randomized between the drug and a placebo in the double-blind studies, which will evaluate the clinical indices of rosacea. The primary endpoints are the reductions in inflammatory lesions and erythema. Patients will receive drug or placebo during a 16-week period of administration.

Col-101 was developed using patented, extended-release drug delivery technology from Shire Laboratories Inc., a subsidiary of Shire Pharmaceuticals Group plc, of Andover, UK.

Data from the rosacea Phase III trial released in February showed patients experienced clinically and statistically significant improvements in their conditions, compared with patients on placebo. That trial included 134 patients who received a twice-daily, 20-mg dose of doxycycline. Patients showed significantly greater reductions in the number of inflammatory lesions (p=0.009). Also, a greater number of patients on Periostat showed a complete clearing of the disease at 16 weeks, compared to patients on placebo (p=0.014). Erythema scores in patients on Periostat also showed greater improvement than patients on placebo. (See BioWorld Today, Feb. 18, 2004.)

"That [trial] was done with the [twice-daily] formulation of Periostat in a smaller number of patients and was not designed to be a pivotal trial," Pfeiffer said. The company decided to develop the once-a-day formulation for rosacea instead.

Rosacea consists of inflammatory lesions and the appearance of erythema, a persistent redness of the skin that affects the nose, cheeks and forehead. As it becomes more severe, pain and itching can occur.

CollaGenex began its Phase III trial of Col-101 in adult periodontitis in April. A U.S. regulatory filing in that indication should occur in 2005. Approval and launch is expected during 2006.

The company's stock (NASDAQ:CGPI) rose 60 cents on Tuesday, to close at $9.30.

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