FDA Grants Marketing Clearance for New Formulation of Fluorouracil

March 1, 2001

The US Food and Drug Administration (FDA) recently granted marketing clearance for a new formulation of fluorouracil (5-FU) as treatment of actinic keratoses. This "Microsponge" formulation of the antimetabolite, manufactured by Advanced

The US Food and Drug Administration (FDA) recently grantedmarketing clearance for a new formulation of fluorouracil (5-FU) as treatment ofactinic keratoses. This "Microsponge" formulation of theantimetabolite, manufactured by Advanced Polymer Systems, Inc, has demonstratedefficacy in achieving clearance of actinic keratoses in phase III clinicalstudies involving 384 patients. The product will initially be marketed in theUnited States by Dermik Laboratories, an Aventis company. A New Drug Application(NDA) was filed by Dermik in the fourth quarter of 1999.

Effective Treatment of Serious Skin Conditions

"Through initial use in Retin-A Micro for the treatment ofacne, and now in 5-FU, we have demonstrated the use of the Microsponge system indelivering highly effective therapeutic treatments for serious skinconditions," said Michael P. J. O’Connell, president and chief executiveofficer of Advanced Polymer Systems, Inc.

The patented Microsponge system consists of porous polymericmicrospheres that are loaded with an active ingredient such as 5-FU. Theparticles are dispersed in a cream and hold the active ingredient until appliedto the skin. This permits the design of unique therapeutic formulations. Thesafety of the Microsponge systems has been well established, and they are usedin several over-the-counter drug and skin care products besides the twoprescription products, Retin-A Micro and the new 5-FU product.

"Our research and development efforts are moving towardestablishing new pharmaceutical collaborations and developing additional productapplications with partners for our new oral and bioerodible polymer deliverysystems for use in broader pharmaceutical markets," said Mr. O’Connell.