Medicis; Time Runs Out for California Physicians: Common Head Lice Treatment Now Forbidden
SCOTTSDALE, Ariz.--Jan. 29, 2002--Time just ran out for health care practitioners battling resistant head lice. Based on a new law that took effect this January, the pesticide lindane can no longer be sold or used for treating lice in California. A highly effective alternative for physicians is OVIDE(R) (malathion) Lotion, 0.5%.
Governor Gray Davis (D) introduced the law because of concerns about lindane's toxicity and its contamination of the Los Angeles County water supply (1). In California, lindane was commonly prescribed for the treatment of lice and scabies. Each year, an estimated 40,000 prescriptions for head lice are issued in California.
"Lindane is less effective and has more potential toxicity than the easily available alternatives; therefore, there is no reason to continue prescribing lindane for the control of head lice in California,"(1) according to the California State Department of Health Services.
For California physicians, the only prescription alternative indicated for head lice is OVIDE(R) Lotion. OVIDE Lotion is a prescription head lice treatment product that contains the pharmaceutical grade of malathion, which has been approved by the FDA and is highly effective and safe when used as directed. This product is Medicaid and Medi-Cal approved.
"OVIDE Lotion is one of the best topical treatments for resistant head lice," said Ronald C. Hansen, M.D., professor of pediatrics and dermatology at the University of Arizona in Tucson. "It has been proven to successfully kill head lice and their nits. And to our knowledge, there is no resistance to it in the U.S."
More than six million American children are infested with head lice each year. Recent studies show that head lice have become resistant to many over-the-counter treatments (2). Before OVIDE Lotion became available, practitioners had few options for treating resistant head lice. Today, the active ingredient in OVIDE Lotion is the recommended prescription alternative when over-the-counter treatments fail, according to a consensus panel of experts (3). For more information about the medical use of OVIDE Lotion including the full prescribing information, visit www.ovide4headlice.com, or call 1-800-550-5115 for a FREE brochure on how OVIDE Lotion is used to treat head lice.
Safety Information: Minor side effects observed in trials of malathion lotion, 0.5%, include a temporary increase in dandruff in those prone to this condition. Irritation to the skin and scalp is the most common adverse reaction. Accidental contact with the eyes can result in mild conjunctivitis. OVIDE Lotion is contraindicated for neonates and infants. Because this product contains alcohol, it is flammable. Keep away from heat sources (i.e., hair dryers, cigarettes) or open flame while the hair is wet.
OVIDE Lotion is marketed by Ascent Pediatrics, Inc., a wholly owned subsidiary of Medicis Pharmaceutical Corporation (NYSE:MRX).
Medicis is a specialty pharmaceutical company and the leading independent pharmaceutical company in the United States focusing primarily on the treatment of dermatological and pediatric conditions. Medicis develops and markets leading products for major segments within dermatology, including acne, fungal infections, rosacea, hyperpigmentation, photoaging, psoriasis, eczema, skin and skin-structure infections, seborrheic dermatitis, head lice and cosmesis (improvement in the texture and appearance of skin).
Ascent Pediatrics, the Company's wholly owned pediatric subsidiary, markets leading pediatric products for the treatment of asthma and other respiratory inflammatory conditions; acute otitis media, or middle ear infections; and an over-the-counter saline nasal mist.
The Company's brands include the prescription brands DYNACIN(R) (minocycline HCl), LOPROX(R) (ciclopirox), LUSTRA(R) (hydroquinone), LUSTRA-AF(R) (hydroquinone) with sunscreen, ALUSTRA(TM) (hydroquinone) with retinol, PLEXION(R) (sodium sulfacetamide/sulfur), PLEXION TS(TM) (sodium sulfacetamide/sulfur), TRIAZ(R) (benzoyl peroxide), OMNICEF(R) (cefdinir), ORAPRED(R) (prednisolone sodium phosphate), OVIDE(R) (malathion), LIDEX(R) (fluocinonide), SYNALAR(R) (fluocinolone acetonide) and TOPICORT(R) (desoximetasone); the over-the-counter brands ESOTERICA(R); and BUPHENYL(R) (sodium phenylbutyrate), a prescription product indicated in the treatment of Urea Cycle Disorder.
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. The Company cannot validate its assumptions of the full impact on its business of the approval of competitive generic versions of the Company's core brands, or any future competitive product approvals that may affect the Company's brands. 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 and there are a number of important factors that could cause actual results to differ materially from those projected, including the ability of Medicis to successfully integrate Ascent's operations, the ability to realize anticipated synergies and benefits of the transaction, 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 introductions 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, 2001. 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 is a registered trademark of Abbott Laboratories, Inc. under a license from Fujisawa Pharmaceutical Co., Ltd. All other marks (or brands) and names are the property of Medicis Pharmaceutical Corporation or its Affiliates.
References:
1. California Code Health and Safety Code, Section 111225-111246 @ www.leginfo.ca.gov. 2. Pollack RJ, Kiszewski A, Armstrong P, et al. Differential permethrin susceptibility of head lice sampled in the United States and Borneo. Arch Pediatr Adolesc Med 1999;153:969-973. 3. Hansen RC, Brogdon WG, Dillenberg J, et al. Guidelines for the treatment of resistant pediculosis. Contemp Ped 2000; (suppl):1-10. Sponsored by an educational grant from MEDICIS, The Dermatology Company(R).
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Contacts: Medicis Libby Ivy (IR), 602/808-3854 URL: www.medicis.com or Health Info, Inc. Marita Gomez, 847/995-0085 mgomez@healthinfodirect.com