Medicis Announces FDA Approval of AMMONUL for Urea Cycle Disorder

    Business Editors/Healthcare Editors

    SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Feb. 18, 2005--Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration ("FDA") has approved AMMONUL(R) as an adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. FDA granted AMMONUL(R) orphan drug status with seven years of exclusivity based on long-term compassionate patient use in patients with Urea Cycle Disorder ("UCD"). UCD is an inherited, inborn error of metabolism. Patients with UCD lack one of the key enzymes that comprise the urea cycle, which can result in the life-threatening condition of hyperammonemia, i.e., dangerously heightened levels of ammonia in the bloodstream.
    AMMONUL(R) is a hospital product administered intravenously as a rescue medication when a UCD patient progresses into a hyperammonemic crisis. AMMONUL(R) works by scavenging ammonia directly from the bloodstream, independent of the defective urea cycle. BUPHENYL(R) (sodium phenylbutyrate), another Medicis prescription product indicated for UCD, is the only FDA-approved drug for maintenance treatment of UCD patients in the U.S. BUPHENYL(R) tablets and powder are used for daily, life-long maintenance in UCD patients and work much the same as AMMONUL(R) by scavenging ammonia from the bloodstream.
    The annual incidence rate of UCD in the United States is approximately one in 30,000 live births. Historically, less than 5% of UCD patients survived the disorder, as the infant patient would appear simply septic. With the increasing awareness of UCD and the availability of AMMONUL(R) as a rescue medication, statistics have improved drastically to over a 90% survival rate.(1)
    "We are pleased to announce FDA's approval of AMMONUL(R), the only acute care medication for Urea Cycle Disorder available in the U.S.," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "FDA's acknowledgment of the safety and efficacy of this important rescue drug is great news for patients, and will prove significant for Medicis. AMMONUL(R) joins BUPHENYL(R) as the only other drug approved to treat this rare and life-threatening disorder, making Medicis the only company offering a complete UCD treatment therapy."
    AMMONUL(R) is the only prescription drug available with the proven combination of 10% sodium phenylacetate and 10% sodium benzoate.
    AMMONUL(R) is available by prescription and administered intravenously in the hospital setting (NDC #62592-720-50). Although rare, vomiting, hyperglycemia, hypokalemia, convulsions and mental impairment have been reported with sodium phenylacetate and sodium benzoate therapy. AMMONUL(R) is contraindicated for use by patients with known hypersensitivity to sodium phenylacetate and sodium benzoate. When used as directed, AMMONUL(R) is safe and efficacious as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the area cycle. Full prescribing information for AMMONUL(R) can be obtained by contacting Medicis. Consult your physician to learn more about AMMONUL(R).
    Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and podiatric conditions and aesthetics medicine. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic categories, including acne, eczema, fungal infections, 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 RESTYLANE(R), DYNACIN(R) (minocycline HCl), LOPROX(R) (ciclopirox), OMNICEF(R) (cefdinir), PLEXION(R) (sodium sulfacetamide/sulfur), TRIAZ(R) (benzoyl peroxide), LIDEX(R) (fluocinonide) Cream, 0.05%, VANOS(TM) (fluocinonide) Cream, 0.1%, and SYNALAR(R) (fluocinolone acetonide), the over-the-counter brand ESOTERICA(R), and BUPHENYL(R) (sodium phenylbutyrate) and AMMONUL(R) (sodium phenylacetate/sodium benzoate), prescription products indicated in the treatment of Urea Cycle Disorder. For more information about Medicis, please visit the Company's website at www.medicis.com.

    Except for historical information, this press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements. This includes earnings estimates, future financial performance and other matters. These statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. Any such projections or statements include the current views of Medicis with respect to future events and financial performance. No assurances can be given, however, that these events will occur or that such results will be achieved. Medicis cannot validate its assumptions of the full impact on its business of the approval of competitive generic versions of its core brands, including DYNACIN(R) Tablets and/or LOPROX(R), or any future competitive product approvals that may affect its brands. Also, there are a number of additional important factors that could cause actual results to differ materially from those projected, including the anticipated size of the markets, the availability of product supply, the receipt of required regulatory approvals, the ability to realize anticipated synergies and benefits of the Q-Med transactions, the risks and uncertainties normally incident to the pharmaceutical industry, dependence on sales of key products, the uncertainty of future financial results and fluctuations in operating results, dependence on Medicis' strategy including the uncertainty of license payments and/or other payments due from third parties, the timing and success of new product development by Medicis or third parties, product introductions, the risks of pending or future litigation, and other risks described from time to time in Medicis' SEC filings including its Annual Report on Form 10-K for the year ended June 30, 2004. There can be no assurance as to when or if any of the holders of the Notes will have the right to convert or if the Notes will be converted, and what impact the increase in the number of shares outstanding will have on its results of operations. Forward-looking statements represent the judgment of Medicis' management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements.

    NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company. OMNICEF(R) is a registered trademark of Abbott Laboratories, Inc. under a license from Fujisawa Pharmaceutical Co., Ltd. RESTYLANE(R) is a registered trademark of HA North American Sales AB, a subsidiary of Medicis Pharmaceutical Corporation. All other marks (or brands) and names are the property of Medicis or its Affiliates.

    References

    (1) Comprehensive Clinical Report entitled "Treatment of Episodic Hyperammonemia in Patients with Urea Cycle Disorders and Prospective Treatment in Infants with Suspected Urea Cycle Disorders with Intravenous Sodium Phenylacetate/Sodium Benzoate"

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CONTACT: Medicis, Scottsdale Kara Stancell, 602-808-3854

KEYWORD: ARIZONA INDUSTRY KEYWORD: GOVERNMENT PHARMACEUTICAL MEDICAL DEVICES BIOTECHNOLOGY PRODUCT SOURCE: Medicis

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