Topical Formulations in the News
Two developers of drug-delivery technology, Advanced Polymer Systems, Inc. (APS; Redwood City, Calif.) and Connetics Corp. (Palo Alto, Calif.) have updated their progress in new product development. APS has an R&D project with Pharmacia and Upjohn Consumer Healthcare (Kalamazoo, Mich.); Connetics has filed an NDA for a mousse formulation and entered an agreement to produce a second mousse product.
APS Moving with Microsponge
Late last year Pharmaceutical Online reported on APS's Microsponge technology. The company has now entered an agreement with Pharmacia and Upjohn to apply Microsponge to undisclosed topical therapeutic agents "which require human clinical testing." Pharmacia and Upjohn will fund product development, conduct clinical studies needed for FDA marketing clearance, and take charge of worldwide commercialization. APS will receive research and development funding, license fees, milestone payments, and royalties on worldwide product sales.
APS's polymer-based drug delivery systems, Microsponge and Polytrap, deliver ingredients to the skin gradually by passive diffusion. Microsponge is an inert, porous, nonbiodegradable acrylate or styrene divinyl benzene copolymer particle 15-20 micrometers in size. Polytrap is a hydrophobic product that controls oils and lipids on the skin without over-drying. More than 100 personal care products on the market today use either Microsponge or Polytrap.
Connetics Moves on Two Mousse Formulations
Within one week Connetics Corp. has filed its first NDA, for Betmethasone Mousse, and entered an agreement with the Australian firm Soltec Research Pty. Ltd. to develop and market clobetasol mousse.
Betamethasone Mousse is a stabilized foam formulation of betamethasone 17-alpha-valerate, a mid-potency anti-inflammatory topical corticosteroid. Worldwide markets for such drugs are about $200 million per year. When applied to the skin the mousse liquefies and remains localized at the disease site. The mousse is easier to apply, less messy, and cosmetically more acceptable than currently marketed dermatological lotions, creams, and ointments. Connetics hopes to market its mousse formulation for all steroid-responsive dermatoses, including psoriasis.
In the clinical trial which ended in August, 1997, betamethasone mousse proved superior to both placebo and betamethasone lotion. Data showed statistically significant improvement over placebo for erythema, plaque thickness and scaling. Sixty-seven percent of patients treated with the mousse formulation had complete or almost complete clearance compared with 46 percent for a currently approved betamethasone lotion and 19 percent for placebo.
The clobetasol agreement extends the mousse formulation to another important topical anti-inflammatory steroid and even larger markets. Demand for clobetasol and other high-potency topical corticosteroids has reached $300 million per year. These drugs are used to treat severe dermatites such as psoriasis, atopic dermatitis, and seborrheic dermatitis. Like the betamethasone formulation, clobetasol mousse remains a foam at room temperature but liquefies when it comes into contact with the skin.
By Angelo DePalma
For more information, contact:
Michael O'Connell, CFO, Advanced Polymer Systems, 3696 Haven Ave., Redwood City, CA 94063. Tel: 650-366-2626, ext. 326.
John L. Higgins, CFO, Connetics Corp., 3400 West Bayshore Road, Palo Alto, CA 94303. Tel: 650-843-2800.