DUSA Pharmaceuticals Receives FDA Warning letter

DUSA received a warning letter from the FDA concerning NDA #20-965 (Levulan Kerastick---aminolevulinic acid HCl ) topical solution.

It reads as follows:
"The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed an advertisement (MKT-1330 Rev C) for Levulan
Kerastick (aminolevulinic acid HCl) for Topical Solution, 20% (Levulan Kerastick) submitted by
DUSA Pharmaceuticals, Inc. (DUSA) under cover of Form FDA 2253. The advertisement is false or misleading because it presents efficacy claims for Levulan Kerastick, but omits and minimizes the risks associated with the use of the drug, broadens the indication, and overstates the efficacy of the drug. Therefore, the advertisement misbrands Levulan Kerastick in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. §§ 352(n) and 321(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(5); (e)(6)(i). This advertisement raises significant public health and safety concerns because it suggests that Levulan Kerastick is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience."

Bascially they are saying the company is misrepresenting the product by making claims of treating keratoses without data to support these claims.

SO WHAT IS THIS Levulan Kerastick?

Levulan Kerastick is a topical treatment for actinic keratoses (AK). Actinic keratoses are a direct result of prolonged exposure to sunlight. It is a small crusty, scaly or crumbly bump or horn that arises on the skin surface. They most likely appear on the face, lips, ears, scalp, neck, backs of the hands and forearms, shoulders and back — the parts of the body most often exposed to sunshine. AK's are considered the earliest stage in the development of skin cancer and they have the ability to progress into malignant skin cancer (squamous cell carcinoma).

The mechanism of action of levulan is not completely known and what is know in complicated. In brief, the drug consists of aminolevulinic acid (ALA) which is involved in heme synthesis (circular molecular structures much like the heme group in hemoglobin that carries molecular oxygen in red blood cells). The aminolevulinic acid is activated by sunlight and another product the patient applies that centers a very specific wavelength of light onto the affected area. When activated by light, the ALA is converted to another compound which then releases molecular oxygen (free radicals) and hydroxide ions. These molecular entities act as cytotoxic agents to kill kertosis developing cells.
That's a very basic mechanism of action of how this drug works, and has very complicated chemistry involved that I'm not exactly clear on either. Hope this helps.

DUSA closed friday's trading up 23 cents per share at $3.43. Investors do not seem to be worried.