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 NYSE See: New York Stock Exchange :MRX MRX Mission Rehearsal Exercise (US DoD) MRX Mental Retardation, X-Linked MRX Magneto-Resistive Extended MRX Magnetic Resonance, Soft Spectrum Coupled X-Ray Laser ) today announced an exclusive agreement for Medicis to promote Omnicef(R) (cefdinir) capsules, Abbott's cephalosporin cephalosporin (sĕf'əlōspôr`ĭn), any of a group of more than 20 antibiotics derived from species of fungi of the genus Cephalosporium and closely related chemically to penicillin. Cephalosporins, e.g. antibiotic, for treatment of uncomplicated skin and skin structure infections in the dermatology and podiatry podiatry (pōdī`ətrē, pə–), science concerned with disorders, diseases, and deformities of the feet, also called chiropody. Podiatrists treat such common conditions as bunions, corns and calluses, and ingrown toenails. 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 semisynthetic /semi·syn·thet·ic/ (-sin-thet´ik) produced by chemical manipulation of naturally occurring substances. sem·i·syn·thet·ic adj. 1. cephalosporin. Its molecular structure provides bactericidal bactericidal /bac·te·ri·ci·dal/ (bak-ter?i-si´d'l) destructive to bacteria. Bactericidal An agent that destroys bacteria (e.g. activity against Staphylococcus aureus Staphylococcus au·re·us n. A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning. Staphylococcus aureus Staphylococcus pyogenes , including beta-lactamase producing strains, and Streptococcus pyogenes Streptococcus py·og·e·nes n. A bacterium that causes the formation of pus or of fatal septicemias. Streptococcus pyogenes A common bacterium that causes strep throat and can also cause tonsillitis. 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 chronic bronchitis n. Inflammation of the bronchial mucous membrane, characterized by cough, hypersecretion of mucus, and expectoration of sputum over a long period of time and associated with increased vulnerability to bronchial infection. caused by Haemophilus 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 max·il·lar·y adj. Of or relating to a jaw or jawbone, especially the upper one. n. A maxillar; a jawbone. maxillary (mak´siler´ē), adj sinusitis sinusitis Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise. caused by Haemophilus influenzae, 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 oropharynx /oro·phar·ynx/ (-far´inks) the part of the pharynx between the soft palate and the upper edge of the epiglottis. o·ro·phar·ynx n. . Cefdinir has not, however, been studied for the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis. Only intramuscular intramuscular /in·tra·mus·cu·lar/ (-mus´ku-ler) within the muscular substance. in·tra·mus·cu·lar adj. Abbr. IM Within a muscle. 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 moniliasis, a former name for candidiasis. (4 percent of women), nausea (3 percent), headache (2 percent), abdominal pain (1 percent) and vaginitis vaginitis Inflammation of the vagina. The chief symptom is a whitish or yellowish vaginal discharge. Treatment depends on the cause: appropriate drugs for sexually transmitted diseases (often from Gardnerella bacteria or trichomonads) or yeast infections; estrogen cream for (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 Rosacea Definition Rosacea is a skin disease typically appearing in people during their 30s and 40s. It is marked by redness (erythema) of the face, flushing of the skin, and the presence of hard pimples (papules) or pus-filled pimples (pustules), and , seborrheic dermatitis, head lice and cosmesis (improvement in the texture and appearance of skin). Primary products include the prescription brands DYNACIN(R) (minocycline HCl), TRIAZ(R) (benzoyl peroxide), LUSTRA Lustra® Hydroquinone Dermatology A topical agent used to manage UV-induced skin discoloration and hyperpigmentation due to trauma, pregnancy, OCs, HRT. See Tanning. (R) (hydroquinone hydroquinone /hy·dro·quin·one/ (hi?dro-kwi-non´) the reduced form of quinone, used topically as a skin depigmenting agent. hy·dro·qui·none n. ), LOPROX(R) (ciclopirox), OVIDE(R) (malathion), PLEXION(TM) (sodium sulfacetamide/sulfur), LIDEX(R) (fluocinonide), SYNALAR(R) (fluocinolone acetonide), TOPICORT(R) (desoximetasone) and A/T/S(R) (erythromycin erythromycin (ĭrĭth'rōmī`sĭn), any of several related antibiotic drugs produced by bacteria of the genus Streptomyces (see antibiotic). ); the over-the-counter brand ESOTERICA esoterica Medtalk A synonym for 'oddballs'–unusual causes of common complaints. See Anecdotal, Fascunomia. (R); and BUPHENYL(TM) (sodium phenylbutyrate), a prescription product indicated in the treatment of Urea Cycle Disorder urea cycle disorder Any disorder in which the body is unable to excrete waste nitrogen–ammonia–resulting in mental and behavioral dysfunction, coma, death . 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 diluted earnings per share An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of 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. |
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