Seborrheic Dermatitis

Medicis Announces FDA Approval of LOPROX Shampoo -ciclopirox- 1%
3/3/03 1:07 PM
Source: Business Wire

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–March 3, 2003–Medicis (NYSE:MRX)
today announced it has received approval of its New Drug Application
from Food and Drug Administration ("FDA") to market its new LOPROX(R)
Shampoo (ciclopirox) 1%. LOPROX(R) Shampoo is the first and only
prescription antifungal shampoo approved in the United States for the
treatment of seborrheic dermatitis of the scalp, a common fungal
infection.

LOPROX(R) Shampoo will have market exclusivity for a three-year
period and is the subject of a pending patent application, which, if
granted, could extend product exclusivity significantly. FDA approval

of LOPROX(R) Shampoo obligates Medicis to pay to Aventis $5 million,
representing the Company’s last financial obligation to Aventis under
terms of the LOPROX(R) transaction announced in fiscal year 1999. The
Company expects to amortize this payment over a period of time
consistent with the LOPROX(R) family of products.

LOPROX(R) Shampoo formulation is the most recent innovation to the
LOPROX(R) family of antifungal products. The brand is the number one
prescribed topical antifungal therapy in the specialties of
dermatology and podiatry.

LOPROX(R) Shampoo is a prescription product and is available in a 120
ml size (NDC #99207-010-10). The Company expects product supply to be
available within the next several months for shipping to wholesalers
and anticipates promotion and sample distribution of LOPROX(R)
Shampoo to physicians soon thereafter.

Seborrheic dermatitis is a common, chronic skin condition affecting
approximately eight million Americans. Skin lesions caused by
seborrheic dermatitis are typically located in areas abundant with
sebum-producing glands including the scalp, face and upper trunk.
Seborrheic dermatitis of the scalp is a common fungal infection
characterized by inflammation, itching, and greasy scaling. This
condition affects about 3% of the general population and can worsen
if left untreated.

New LOPROX(R) Shampoo is an effective delivery system to treat
seborrheic dermatitis of the scalp. A small percentage of people may
experience side effects such as rash or other discomfort around the
scalp.

"We are pleased to announce approval of LOPROX(R) Shampoo, the first
and only prescription antifungal shampoo indicated for the treatment
of seborrheic dermatitis of the scalp," said Jonah Shacknai, chairman
and chief executive officer of Medicis. "Approval of the Company’s
first full New Drug Application is encouraging and reflects the
increasing sophistication of our research and development pipeline.
LOPROX(R) Shampoo is clinically proven to provide safe and effective
treatment of seborrheic dermatitis of the scalp and has the potential
to greatly enhance the success of this important brand."

Medicis is the leading independent specialty pharmaceutical company
in the United States focusing primarily on the treatment of
dermatological, pediatric and podiatric conditions. Medicis has
leading prescription products in a number of therapeutic categories,
including acne, asthma, eczema, fungal infections, hyperpigmentation,
photoaging, psoriasis, rosacea, seborrheic dermatitis and skin and
skin-structure infections. The Company’s products have earned wide
acceptance by both physicians and patients due to their clinical
effectiveness, high quality and cosmetic elegance.

The Company’s products include the prescription brands DYNACIN(R)
(minocycline HCl), LOPROX(R) (ciclopirox), LUSTRA(R) (hydroquinone),
LUSTRA-AF(R) (hydroquinone) with sunscreen, ALUSTRA(R) (hydroquinone)
with retinol, OMNICEF(R) (cefdinir), ORAPRED(R) (prednisolone sodium
phosphate), PLEXION(R) Cleanser (sodium sulfacetamide/sulfur),
PLEXION TS(R) (sodium sulfacetamide/sulfur), PLEXION SCT(R) (sodium
sulfacetamide/sulfur), TRIAZ(R) (benzoyl peroxide), LIDEX(R)
(fluocinonide), and SYNALAR(R) (fluocinolone acetonide); the over-the-
counter brand ESOTERICA(R); and BUPHENYL(R) (sodium phenylbutyrate),
a prescription product indicated in the treatment of Urea Cycle
Disorder. For more information about Medicis, please visit the
Company’s website at www.medicis.com.

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