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Medicis to License Abbott Laboratories' Omnicef - cefdinir - in the U.S. in Dermatology and Podiatry.


Business Editors & Health/Medical Writers

ABBOTT PARK, Ill. and SCOTTSDALE, Ariz.--(BW HealthWire)--May 10, 2001

Partnership With Leading Dermatology Company

Expands Market for Omnicef

Abbott Laboratories and Medicis Pharmaceutical Corporation (NYSE:MRX) today announced an exclusive agreement for Medicis to promote Omnicef(R) (cefdinir cefdinir /cef·din·ir/ (sef´di-nir) a third-generation cephalosporin cephalosporin /ceph·a·lo·spo·rin/ (sef?ah-lo-spor´in) any of a group of broad-spectrum, penicillinase-resistant antibiotics from Acremonium, related to the penicillins in both structure and mode of action. Those used medicinally are semisynthetic derivatives of the natural antibiotic cephalosporin C. effective against a wide range of bacteria.

cef·di·nir (sf
) capsules, Abbott's cephalosporin antibiotic, for treatment of uncomplicated skin and skin structure infections in the dermatology and podiatry arenas. Medicis is the leading independent pharmaceutical company focusing on the dermatology and podiatry markets. Abbott will continue to promote Omnicef to primary care physicians and pediatricians.

Omnicef is an extended-spectrum, semisynthetic cephalosporin. Its molecular structure provides bactericidal activity against Staphylococcus aureus, including beta-lactamase be·ta-lac·ta·mase (bt-lk producing strains, and Streptococcus pyogenes in uncomplicated skin and skin structure infections. Omnicef was launched as a 300 mg capsule formulation in August 1998. Abbott obtained U.S. marketing rights to Omnicef in December 1998 through an agreement with Warner-Lambert Company. In the U.S., the market for treatment of bacterial skin and skin structure infections is estimated to be more than $1.5 billion.

"Due to its efficacy against these common gram-positive organisms, Omnicef is an excellent option for the treatment of uncomplicated skin and skin structure infections," said Jerry Wenker, vice president and general manager, Anti-Infective Franchise at Abbott. "Through this new partnership with Medicis, we gain the experience of one of the leaders in dermatology to reach an untapped market for Omnicef with dermatologists and podiatrists. This will expand the use of Omnicef into dermatology, branching beyond its base market strength in respiratory infections."

"Medicis currently has market-leading brands in several therapeutic categories, and we look forward to introducing Omnicef to dermatologists and podiatrists," said Jonah Shacknai, chairman and chief executive officer of Medicis. "Clearly, there is a need for an extended-spectrum antibiotic in these specialties, and we believe that Medicis is the right company to help our physician audience understand the benefits of Omnicef therapy. We expect this transaction to be accretive to earnings and to help us expand our sales force by 25% without impact on near-term earnings expectations."

Under the terms of the agreement, Omnicef capsules will be promoted to dermatologists and podiatrists in the U.S. exclusively by Medicis; marketing to primary care physicians and pediatricians will remain with Abbott. Financial terms of the agreement include an initial milestone payment to Abbott. Medicis will receive revenue from prescriptions generated in the dermatology and podiatry categories. Medicis will begin to promote and sell Omnicef in the near future.

In adult, adolescent and pediatric patients, Omnicef is indicated for mild to moderate uncomplicated skin and skin structure infections due to Staphylococcus aureus, including beta-lactamase producing strains, and Streptococcus pyogenes.

In adult and adolescent patients, Omnicef is also indicated for community acquired pneumonia and acute exacerbations of chronic bronchitis caused by Haemophilus He·moph·i·lus (h-mf-l influenzae, including beta-lactamase-producing strains, Haemophilus parainfluenzae, including beta-lactamase-producing strains, Morexella catarrhalis, including beta-lactamase-producing strains, and penicillin-susceptible strains of Streptococcus pneumoniae. In these patients, Omnicef is also used for acute maxillary sinusitis caused by Haemophilus influenzae Haemophilus in·flu·en·zae (nfl-n, including beta-lactamase-producing strains, Morexella catarrhalis, including beta-lactamase-producing strains, and penicillin-susceptible strains of Streptococcus pneumoniae.

In pediatric patients, Omnicef is indicated for acute bacterial otitis media caused by Haemophilus influenzae, including beta-lactamase-producing strains, Morexella catarrhalis, including beta-lactamase-producing strains, and penicillin-susceptible strains of Streptococcus pneumoniae.

Omnicef is also indicated in adult, adolescent and pediatric patients for mild-to-moderate pharyngitis/tonsillitis due to Streptococcus pyogenes. Cefdinir is effective in the eradication of Streptococcus pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

In clinical trials Omnicef was well tolerated and the most common adverse events were diarrhea (15 percent), vaginal moniliasis mo·ni·li·a·sis (mn-l (4 percent of women), nausea (3 percent), headache (2 percent), abdominal pain (1 percent) and vaginitis (1 percent of women) in adults and adolescents and diarrhea (8 percent), rash (3 percent) and vomiting (1 percent) in pediatrics.

Omnicef is contraindicated in patients with known allergy to the cephalosporin class of antibiotics. Patients with a previous hypersensitivity reaction to penicillins should be closely monitored when taking Omnicef. If an allergic reaction to Omnicef occurs, the drug should be discontinued. The safety and efficacy of Omnicef in neonates and infants less than six months of age have not been established.

Medicis is the leading independent pharmaceutical company in the United States focusing primarily on the treatment of dermatological conditions. Medicis develops and markets leading products for major segments within dermatology, including acne, fungal infections, psoriasis, eczema, rosacea, seborrheic dermatitis, head lice and cosmesis cosmesis /cos·me·sis/ (koz-me´sis)
1. the preservation, restoration, or bestowing of bodily beauty.
2. the surgical correction of a disfiguring physical defect.
 (improvement in the texture and appearance of skin). Primary products include the prescription brands DYNACIN(R) (minocycline HCl), TRIAZ(R) (benzoyl peroxide), LUSTRA(R) (hydroquinone), LOPROX(R) (ciclopirox), OVIDE(R) (malathion), PLEXION(TM) (sodium sulfacetamide/sulfur), LIDEX(R) (fluocinonide), SYNALAR(R) (fluocinolone acetonide), TOPICORT(R) (desoximetasone desoximetasone /des·ox·i·met·a·sone/ (des-ok?se-met´ah-son) a synthetic corticosteroid used topically for the relief of inflammation and pruritus in corticosteroid-responsive dermatoses.

des·ox·i·met·a·sone (d
) and A/T/S(R) (erythromycin erythromycin /eryth·ro·my·cin/ (-mi´sin) a broad-spectrum antibiotic produced by Streptomyces erythreus; used against gram-positive bacteria and certain gram-negative bacteria, spirochetes, some rickettsiae, Entamoeba, and Mycoplasma pneumoniae; used in the form of the gluceptate, lactobionate, stearate, and other salts.); the over-the-counter brand ESOTERICA(R); and BUPHENYL(TM) (sodium phenylbutyrate), a prescription product indicated in the treatment of Urea Cycle Disorder. Full prescribing information for any Medicis prescription product is available by contacting the Company. The Company's press releases and other information are available on the Company's Web site at www.medicis.com.

Abbott has a long history of leadership in anti-infectives, dating back to the development of its first antibiotic. Abbott was one of the five pioneers in the United States to start commercial production of penicillin. Years later, in conjunction with the research efforts of two other pharmaceutical companies, the company developed erythromycin, which is still widely used today. Abbott continues to be the number one marketer of macrolides. Abbott's commitment continues today with extensive research to discover and develop new compounds in this area.

Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs 70,000 people and markets its products in more than 130 countries. In 2000, the company's sales and net earnings were $13.7 billion and $2.8 billion, respectively, with diluted earnings per share of $1.78.

Abbott's news releases and other information, including Omnicef full prescribing information are available on the company's Web site at www.abbott.com.

Medicis Conference Call

Medicis will host a conference call at 5:15 p.m. Eastern Time (2:15 p.m. Pacific Time) today to review the Omnicef license agreement, as well as provide an update on any other business matters of the Company. A live webcast will also be available at http://www.medicis.com and http://www.streetevents.com. The webcast will be archived on the Company's Web site for two business days following the live call.

The phone number to join the conference call is (719) 457-2653 for both domestic and international callers. No access code is necessary for the live call. For investors unable to participate in the live call, a replay will be available soon after the live call. The phone number to access the replay is (719) 457-0820 and the access code is 493465. The replay will be available for two business days following the live call.

Safe-Harbor Statement

Except for historical information, this news release contains certain forward-looking statements that involve risks and uncertainties which may cause actual results to differ materially from the statements made, including the companies' (Abbott Laboratories and/or Medicis Pharmaceutical) dependence on sales of the licensed product or any other key products; the effectiveness and/or safety profile of the licensed product or any of the companies' other key products; risks associated with the manufacture of the licensed product or any other of the companies' key products; uncertainty of future financial results and/or fluctuations in operating results; any changes in the licensed product's competitive, regulatory or managed-care environment or any other key products' competitive, regulatory or managed-care environments; dependence on the companies' acquisition strategies, new product introductions and other risks described from time to time in the companies' SEC filings. These forward-looking statements represent the judgment of the companies, as of the date of this release, and Abbott and/or Medicis disclaim any intent or obligation to update these forward-looking statements.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:May 10, 2001
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