NEWS — DECEMBER 2006

ACNE NEWS

The 2005 global prescription acne market generated an estimated $2.8 billion. [1]

Products & Treatments

Fougera's Generic Product Receives FDA Approval

In mid-November, the Fougera division of ALTANA (Melville NY) received approval from the U.S. Food And Drug Administration (FDA; Rockville MD) to market the first generic alternative to KLARON® from Dermik (Berwyn PA). Fougera's Sulfacetamide Sodium Topical Suspension USP 10% is a prescription product that will compete in a market segment that had been dominated by KLARON®, which generated an estimated $25.0 million in 2005 before patent expiration. Fougera specializes in the manufacturing and distribution of multiple source antibiotic, antifungal, ophthalmic, and topical steroid pharmaceuticals. The generic acne medication, Sulfacetamide Sodium Topical Suspension USP 10%, became commercially available on November 18th, 2006.

Zeno Treatment Device Available For At-Home Use

Tyrell Inc. (Houston TX) has expanded its Zeno line of acne treatment devices to meet consumer needs. Initially, Zeno was sold only to medical spas and physicians. The device incorporates the Company's proprietary Clearpoint technology, applying heat to affected areas to kill acne bacteria. An FDA-reviewed clinical trial demonstrated that 90% of pimples treated with Zeno improved or resolved within 24 hours.

In November 2006, Walgreens became the exclusive national drugstore retailer for the at-home model of Zeno and Zeno replacement treatment tips. Zeno Pro and Zeno MD are newly introduced product variations available through doctors and spas.

In other news, Tyrell Inc. was ranked by the Houston Business Journal as one of the area's 50 best companies. The Company's Zeno technology created a brand new product category in the acne treatment market.

Research & Development

University Of Cincinnati Tests New Topical Gel

A multi-center, Phase III trial is in progress at the University Of Cincinnati to investigate the effectiveness of a dual-acting topical gel for acne prevention. Ideally, the new drug will reduce abnormal pore-clogging and inhibit bacterial infections associated with severe acne. Although the exact cause is not known, acne results from various factors. Clogged pores enable excessive bacterial growth, which leads to inflammation.

The new gel was developed by Galderma (Forth Worth TX) by combining two FDA-approved compounds that are currently used as single agents: Retinoid adapalene and benzoyl peroxide. Ideally, the gel will be more effective and convenient to use. The study will involve approximately 40 subjects age 12 or older who have severe acne. Four treatment groups will be formed for testing each compound individually, the new gel (combined compounds), and a placebo. [The clinical trial is sponsored by Galderma USA.]

Technologies

Quest PharmaTech's SonoLight System

With newly granted patents (November 2006), Quest PharmaTech (Edmonton, Alberta, Canada) has strengthened its position in sonodynamic therapy applications. The SonoLight technology involves the use of non-toxic Hypocrellin derivatives which are activated by light or ultrasound to treat diseases and dermatological conditions. Drugs are currently in development by Quest PharmaTech to treat actinic keratosis, acne, hair removal, and prostate cancer.

Sciton ProFractional Laser Treatment Module

A new module is under development by Sciton Inc. (Palo Alto CA) using ProFractional technology that can be added to the Company's PROFILE™ laser platform. Some of the current procedures performed by the system include the MicroLaserPeel™, laser resurfacing, non-ablative skin treatments, and scar reduction.

The ProFractional module is being investigated by leaders within the aesthetic medicine community. Several have expressed enthusiasm for the device's potential for difficult-to-treat conditions. One example is full face acne scars, which may require treatment deep into the dermis. With the capacity to heat tissue to a depth of 1000 microns , the ProFractional offers a significant advantage for tightening skin and treating wrinkles more effectively in "virtually painless" procedures (when used in conjunction with topical anesthetic cream).

[1] "SkinMedica Targets Acne With Timed Release Approach", In-Pharmatechnologist, News Headlines, February 15th, 2006 (www.in-pharmatechnologist.com)