Dermal augmentation is a rapidly growing market
Injectable Dermal Fillers, such as FibroGen's investigational product FG-5030, are part of a growing market segment known as "Nonsurgical Cosmetic Procedures". According to the American Society for Aesthetic Plastic Surgery (ASAPS), there were over 6 million nonsurgical cosmetic procedures performed in 2003, up from 1.1 million (445% increase) in 1997. Collagen injections (bovine type I collagen) were among the top five non-surgical procedures performed in 2003.

The chart below highlights the five most popular nonsurgical procedures performed in 2003 as reported by the ASAPS.

The ASAPS also reported that collagen procedures increased from 347,168 procedures in 1997 to 620,476 procedures (79% increase) in 2003.

Bovine collagen has historically been the mainstay of the dermal filler market. However, several new dermal filler products have recently been introduced, including products based on cell cultured collagen (from fibroblast cells) and hyaluronic acid, a material derived from bacterial fermentation or extracted from rooster combs. All of these products suffer from limitations including: an incidence of allergic reactions, low persistence, and high production costs (particularly cell cultured derived collagen). For example, one of the major drawbacks of bovine collagen is that a skin test is required prior to use to screen out the approximately 3-5% of persons who are sensitive, or allergic, to this material. FibroGen believes there is a significant need and opportunity for a safe and more effective product in the dermal filler market.

Recombinant human collagen: new approach to cosmetic dermal fillers
FibroGen is developing FG-5030 and FG-5017, unique cosmetic dermal fillers, comprised of fully synthetic human collagen (type III). FibroGen is the only company with proprietary technologies that enable the production of properly formed collagens based on human DNA sequences.

Using in vitro models of dermal augmentation, FibroGen scientists have discovered that formulations based on type III collagen persist longer than those based on type I, which is the main type of collagen in bovine-derived products currently on the market. Thus, FibroGen's investigational product represents a filler with attributes of classical collagen fillers (e.g., ease of administration) with the added benefits of a fully synthetic human collagen (no skin test expected) with longer persistence.

Development of recombinant human collagen dermal fillers
FibroGen expects to enter clinical studies with its cosmetic dermal filler products in 2007. In addition, based on its proprietary technology, FibroGen has begun development of second-generation products to enhance its product offerings for the cosmetic dermatology segment. FibroGen believes that its first generation product will fulfill unmet consumer needs for safety and performance. The chart below compares FibroGen's cosmetic dermal filler product in development to fillers currently approved and marketed in the United States.