Washington Editor

The FDA approved Oracea, a rosacea treatment from CollaGenex Pharmaceuticals Inc.

"Oracea brings everything into sync at the same time," explained President and CEO Colin Stewart. "Dermatologists and patients have never had that before."

Oracea, a 40-mg formulation of the antibiotic doxycycline delivered once a day, is indicated for the dermatologic condition's inflammatory papules and pustules in adult patients. The capsules contain a combination of immediate- and delayed-release beads, and represent the first systemically delivered drug for rosacea approved by the FDA. Oracea inhibits multiple proteases and cytokines that are the condition's basis of inflammation.

"It will give patients, for the first time, an effective anti-inflammatory for the lesions of rosacea for long-term use," Stewart told BioWorld Today, noting that while the condition is episodic, "it's with you for the rest of your life."

Rosacea affects an estimated 14 million adults in the U.S., representing a $500 million market opportunity. Mild patients are treated with fairly safe topicals, but moderate to severe patients also receive acute doses of tetracycline-class antibiotics, a limited therapy because of restrictions to short-term use. The active pharmaceutical ingredient of Oracea belongs to the same class, but because the product is formulated at a sub-antimicrobial level, it retains its anti-inflammatory properties without antibiotic-related issues.

CollaGenex, of Newtown, Pa., plans to launch it in July with an internal sales force trained and ready. While product pricing remains undisclosed, Stewart projected that Oracea's peak annual sales in the U.S. could range between $120 million and $140 million within four years.

Such commercialization efforts should fall into place easily for the specialty pharmaceutical company, given that its sales specialists already market three other dermatology products: Pandel (hydrocortisone probutate), a topical corticosteroid for dermatosis; Alcortin (1 percent iodoquinol and 2 percent hydrocortisone), a topical antifungal steroid combination; and Novacort (2 percent hydrocortisone acetate and 1 percent pramoxine HCl), a topical steroid and anesthetic.

Importantly, patent questions surrounding Oracea could be resolved in about six months. That would give time for reviewers at the U.S. Patent and Trademark Office to contemplate additional information recently submitted by the company regarding an application for the use of sub-antimicrobial and non-antimicrobial tetracyclines for treating acne and acne rosacea, including Oracea. A notice of allowance was issued for the original application in August, and a patent was scheduled to issue this month, but Stewart said the "additive" material was filed because it could be "relevant to their review."

Such a method-of-use patent would supplement existing intellectual property on Oracea's mechanism of action and formulation and serve as part of a broader "patent fence," Stewart said.

Its approval, which came within 10 months of filing its new drug application, was based principally on pivotal data from two Phase III trials. In them, Oracea-treated patients experienced a 61 percent and 46 percent mean reduction in inflammatory lesions, compared to 29 percent and 20 percent, respectively, in patients receiving placebo (p<0.001). The double-blinded studies enrolled a total of 537 patients. (See BioWorld Today, Aug. 2, 2005.)

Oracea is under review in the UK, and Stewart said the company would make use of Europe's mutual recognition procedure to seek clearance throughout that territory. An approval could come in 18 months to 24 months, he said, adding that CollaGenex would seek a partner for overseas marketing.

Other dermatological products in development at the company include incyclinide, an acne treatment in a Phase II dose-finding study enrolling 300 patients. Data are due early next year. Previously, the chemically modified tetracycline was called COL-3. CollaGenex also is developing COL-118, a compound in preclinical development as a topical treatment for redness associated with rosacea and other skin disorders.

Together with Oracea, incyclinide and COL-118 are part of "a powerful suite of products" on which the company has focused almost exclusively, Stewart said, since essentially dissolving its dental franchise by the end of last year. All the new dermatology products stem from the same underlying tetracycline-based platform as the dental products.

On Tuesday, shares in CollaGenex (NASDAQ:CGPI) gained 87 cents, to close at $12.50.

Novelos Forms SPA For Lung Cancer Drug

Novelos Therapeutics Inc. plans to soon begin a Phase III study of its lead product, NOV-002, following FDA clearance on the lung cancer trial's design.

The Newton, Mass.-based company finalized a special protocol assessment with the agency for a single study to serve as a pivotal trial and test the compound's efficacy in advanced non-small-cell lung cancer. The open-label study will enroll 840 patients.

The small molecule will be combined with first-line chemotherapy of paclitaxel and carboplatin in one arm of the randomized, international trial, and the other arm will test paclitaxel and carboplatin alone. Novelos plans to begin recruitment next quarter. Overall survival is its primary efficacy endpoint.

NOV-002, designed to act as a chemoprotectant and an immunomodulator, also is being developed to treat chemotherapy-resistant ovarian cancer and acute radiation injury.

On Tuesday, Novelos' stock (OTCBB:NVLT) fell 9 cents, to close at $1.11.

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