PIPELINE PREVIEWS

Fibrocell Science, Inc. has announced that clinical trial data demonstrating the effectiveness of LAVIV^™ (azficel-T) for the improvement of the appearance of moderate-to-severe nasolabial fold wrinkles has been published online by Dermatologic Surgery and will also be published in an upcoming print issue. LAVIV is an aesthetic treatment made from the patient's own living, cultured, collagen-producing fibroblast cells and then injected into smile-line wrinkles.

The publication in Dermatologic Surgery includes the combined results of two identically-designed, Phase III, multi-center, randomized, double-blind, placebo-controlled, studies of 421 patients that showed statistically significant efficacy results for LAVIV. The criteria for a positive response were a 2-point improvement on the Subject Wrinkle Assessment Scale and a 2-point improvement on the Evaluator Wrinkle Assessment Scale for both nasolabial fold wrinkles. 30% of subjects who received at least one LAVIV injection had a 2-point improvement in the appearance of smile lines 6 months after completing treatment, as rated by investigators, versus 8% for placebo. In self-assessments, 59% of patients reported a 2-point improvement six months after completing treatment, versus 26% for placebo.

The patented technology behind LAVIV is an advanced process that extracts a person's fibroblast cells from a small skin sample and multiplies them in the Fibrocell Science lab. In normal skin, fibroblasts are responsible for producing collagen. LAVIV is the resulting formulation of a person's own living, cultured, fibroblast cells, which is then injected into smile-line wrinkles. Each person's formulation of LAVIV is unique because it is made from his or her own fibroblast cells.

LAVIV was approved by the FDA on June 21, 2011 for the improvement of the appearance of moderate-to-severe nasolabial fold wrinkles in adults and is the only personalized cell therapy approved by the FDA for aesthetic use.

PreCision Dermatology recently announced that it has acquired the assets of Triax Pharmaceuticals, LLC. Triax carries dermatology products such as Locoid^®, Minocin^®, and Tretin-X^™. Onset Dermatologics, a subsidiary of PreCision Dermatology, will now market these products.

Cardium Therapeutics has recently exhibited its FDA-cleared Excellagen^®. This is a wound care product that is carried in a syringe and is used in the treatment of diabetic foot ulcers, pressure ulcers, and other dermal wounds.

Excellagen^® is a fibrillar collagen-based topical gel (2.6%) that has a high molecular weight bovine Type I collagen. This gel is supplied in pre-filled syringes, which are then applied topically to the treatment area by a physician. It promotes a favorable wound-healing environment and requires re-application every 1 to 2 weeks. One syringe with 0.5 cc of Excellagen^® covers wounds up to 5cm2 in size.

Nuvo Research, Inc. recently announced that the topical local anesthetic cream Pliaglis was denied approval by the FDA. Pliaglis was originally developed by Zars Pharma, Inc. and was approved by the FDA in 2006 for topical local analgesia for superficial dermatologic procedures including laser treatments and dermal filler injections. In 2007, Galderma Pharma, S.A. was given promotion and distribution rights for Pliaglis and Galderma voluntarily removed it from the US market in 2008 due to manufacturing issues.

Once these manufacturing issues were resolved, Galderma filed a supplemental New Drug Application for Pliaglis; however, this approval was unsuccessful.

Lutronic, Inc. recently announced that the FDA has granted clearance for marketing of the ADVANTAGE^® diode hair removal laser. Millions of laser hair removal procedures are performed annually. Lutronic states that the ADVANTAGE Laser is faster and more efficacious than other lasers. It does this by using a larger spot size that reduces treatment time. ADVANTAGE allows operators to adjust both the fluence and pulse widths to customize treatments for each patient.

The FDA recently notified health care professionals and warned consumers regarding mercury that may be contained in certain skin creams, soaps or lotions. These products are sold illegally in the United States after being manufactured abroad. They are marketed as skin lighteners and anti-aging treatments. Investigations by the FDA have revealed at least 35 products with levels of mercury that are too high.

The FDA warns that consumers should check labels of skin lightening or anti-aging products for “mercurous chloride, calomel, mercuric, mercurio, or mercury.” If any of these ingredients are present, consumers should discontinue use of the product immediately.