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THERAPLEX OTC SKIN/SCALP CARE LINE FROM EUROPE

Executive Summary

THERAPLEX OTC SKIN/SCALP CARE LINE FROM EUROPE will be the first product offering of a Washington, D.C.-based start-up, Medicis Pharmaceutical. In a Jan. 16 red herring prospectus designed to raise between $7 mil. and $8 mil., Medicis says it will initially market the five-product Theraplex line to dermatologists, pharmacies and stores selling H&BAs. The company introduced the line at the American Academy of Dermatology annual meeting in early December in San Francisco; a trade launch is planned for May. The Theraplex line will consist of an extra strength emollient, a clear lotion and a "hydrolotion for dry or certain inflammatory skin conditions, such as psoriasis, eczema and icthyosis," the prospectus states. Theraplex combines the active fraction of petrolatum with volatile silicones but does not contain "the normally greasy, sticky and odoriforous fractions of the hydrocarbons," making the product more cosmetically acceptable, according to the company. The line also will include two therapeutic shampoos: Theraplex Z Shampoo (zinc pyrithione), and Theraplex T Shampoo (coal tar). Medicis acquired the U.S., Mexico and Japan rights to the Theraplex line in April 1989. Products containing Theraplex have been marketed under different tradenames in Europe. The product is being manufactured for Medicis by the Swiss firm ViFor. Medicis will allocate $1.9 mil. of net proceeds from the D. H. Blair offering to create a sales and marketing force for dermatologicals. Another $187,500 of the proceeds will go to human clinicals for "a prescription topical photoprotective agent" containing the active ingredient bergapten. Marketed as Bergasol in Europe, the product claims to stimulate melanin and reduce sunburning. The company has not initiated U.S. clinicals for the bergapten product yet. It predicts a potential NDA application in 1991. The company's proposed second product for commercialization is a prescription anti-bacterial acne product. Medicis forecasts a launch for the product in 1990, based on the use of a grandfathered active ingredient not subject to premarket approval by FDA. The company says it hopes to begin marketing the acne product in the next six to 12 months. The offering is for 1.2 mil. units, consisting of 7.2 mil. shares of Class A common stock and a like number of redeemable Class A warrants; each unit is comprised of six shares of common and six warrants. The proceeds are expected to keep the company operating for approximately nine months in the absence of any product sales. Approximately $765,900 of the net proceeds will be paid to company insiders and executives in the form of salaries, while another $1.42 mil. will go to repayment of debt, also primarily to the founding members of the company and initial investors. The company's strategic objective is to use the dermatological products to build a marketing presence and tide the company through a development period for several critical care pharmaceuticals. One product in that category is a licensed candidate from Chemie and Biologie in France to reduce mucous viscosity. The compound, Mucoral, is an oral agent in early clinicals outside the U.S. for treating chronic obstructive pulmonary disease, asthma, cystic fibrosis and pneumonia. The company is also working with Walter Reed on binary ligands which may be useful against secondary injury from CNS trauma and stroke. Medicis was founded in 1987 by Jonah Shacknai, a D.C. attorney with experience in FDA legislation. Shacknai was a top staff aide to Rep. Scheuer (D-N.Y.), when the congressman was involved in FDA issues at the beginning of the 1980s. The firm has assembled a group of ex-politicos and international consultants to put together the new firm. Among the political names associated with the company are board member Albert Gore, Sr., a former senator from Tennessee and the father of the current Sen. Gore (D-Tenn.) and Peter Knight, the campaign director of the Gore for President effort in 1988.

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