Allergan's Tazorac receives U.S. marketing approval for the once daily treatment of stable plaque psoriasis and facial acne.IRVINE, Calif.--(BW HealthWire)--June 16, 1997--Allergan, Inc. (NYSE NYSE See: New York Stock Exchange : AGN AGN Again (Amateur Radio) AGN Active Galactic Nucleus AGN Acute Glomerulonephritis AGN Accountants Global Network AGN Air Gabon (ICAO code) ) today announced that it has received approval from the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to market Tazorac(tm) (tazarotene topical gel) 0.05% and 0.1% in the United States for the treatment of stable plaque psoriasis on up to 20 percent body surface area and the 0.1% gel for mild-to-moderately severe facial acne vulgaris acne vul·gar·is n. An inflammatory eruption affecting the face, upper back, and chest, consisting of blackheads, cysts, papules, and pustules, and occurring primarily during puberty and adolescence. . Tazorac(tm) gel is the first of a new generation of topical, receptor-selective retinoids Retinoids A derivative of synthetic Vitamin A. Mentioned in: Ichthyosis retinoids (reˑ·t to be marketed for both of these indications. Applied topically only once daily, Tazorac(tm) gel has shown treatment success in up to 70 percent of patients with stable plaque psoriasis. In clinical trials, Tazorac(tm) gel achieved rapid clinical improvement in plaque psoriasis with a therapeutic effect sustained for up to 12 weeks after treatment. "Tazorac(tm) gel is a new molecular entity and our first new technology discovered in Allergan's research labs to receive approval for U.S. marketing," said Allergan Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. William C. Shepherd. "When treating a chronic disease like psoriasis, the ultimate treatment goal is to clear the skin of lesions and keep it clear. Tazorac(tm) gel is a novel therapy that is well suited for long-term maintenance therapy and will add real value to the management of psoriasis because it is specific to the cellular switches that affect psoriasis." The key to the efficacy of Tazorac(tm) gel in treating stable plaque psoriasis is thought to be in its pharmacological selectivity and its ability to modulate the three key pathogenic characteristics of psoriasis and acne--abnormal keratinocyte keratinocyte /ke·rat·i·no·cyte/ (ker-at´in-o-sit) the epidermal cell that synthesizes keratin, known in its successive stages in the layers of the skin as basal cell, prickle cell, and granular cell. (skin cell) differentiation, hyperproliferation and inflammation. It is believed that Tazorac(tm) gel achieves a rapid, sustained therapeutic effect by normalizing epidermal Epidermal Referring to the thin outermost layer of the skin, itself made up of several layers, that covers and protects the underlying dermis (skin). Mentioned in: Antiangiogenic Therapy, Histiocytosis X epidermal differentiation, reducing hyperproliferation and reducing the influx of inflammatory cells into the skin. In addition, its topical route of delivery directly targets the skin where these processes occur. Tazorac(tm) gel, marketed outside the United States under the global brand name Zorac(r) (tazarotene topical gel), has been cleared for use in Canada and Argentina for the treatment of plaque psoriasis and acne vulgaris and in Germany for the treatment of plaque psoriasis. Approval to market Zorac(r) gel in the balance of the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community through the mutual recognition filing process began in February 1997. To date, applications for marketing approval also have been submitted in Australia, Brazil, Chile, Mexico, New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. , Peru and South Africa. Tazorac(tm) (tazarotene topical gel) 0.05% and 0.1% for plaque psoriasis and 0.1% for acne vulgaris is available by prescription in 30g and 100g tubes. Product will be available in most pharmacies by late June. Psoriasis Clinical Trial Data Results from large-scale clinical studies involving more than 1,400 patients found that up to 70 percent of patients with trunk/limb plaque psoriasis and 60 percent of patients with knee/elbow plaque psoriasis experienced treatment success (defined as good, excellent or complete clearing) with Tazorac(tm) gel. The onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring. was seen as early as one week, and therapeutic benefit was sustained in many patients up to 12 weeks after treatment. Tazorac(tm) gel has a well-documented safety profile. In clinical trials for treatment of stable plaque psoriasis, it has been used on up to 20 percent of the body surface area for as long as one year. Formulated in an aqueous gel, Tazorac(tm) gel is safe to use on most parts of the body, including the face and scalp. The majority of adverse effects, consisting of signs and symptoms of local irritation (which included itching, burning/stinging, erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns. ), were mild-to-moderate and dose-related. Tazorac(tm) is contraindicated in women who are pregnant or may become pregnant. Women of childbearing potential should use adequate birth control measures during treatment with Tazorac(tm) gel. Acne Clinical Trial Data Tazorac(tm) gel, used once-daily for the treatment of mild-to- moderate facial acne vulgaris (common acne), has demonstrated good to excellent efficacy in up to 70 percent of patients and has a well-documented safety profile. In addition, its aqueous gel is cosmetically appealing and is compatible with moisturizers moisturizers hydroscopic agents, applied to the skin and hair, as creams, rinses or shampoos, to increase hydration of the stratum corneum. Examples are propylene glycol, glycerine and lactate. and make-up. About Psoriasis Psoriasis affects up to 3 percent of the world's population, more than 6 million people in the United States alone. It occurs with equal frequency in men and women, and more often in families with previous history--suggesting hereditary factors. Psoriasis is an incurable, non-contagious skin disorder that can be both physically and psycho-socially disabling. It can have a profound influence on the patient's quality of life by affecting employment, sleep and social life. Even the most common form of the disease, stable plaque psoriasis, is a chronic inflammatory disease that is unpredictable in its spontaneous remissions and recurrences. It is characterized by clearly demarcated red patches covered by thick, dry, silvery, adherent adherent /ad·her·ent/ (-ent) sticking or holding fast, or having such qualities. scales. While psoriasis can affect any part of the body's surface, plaques often affect symmetrical regions of the body's skin surface, commonly forming on the elbows, knees, scalp and lower back. Psoriasis can vary greatly in severity between individuals and can cover large areas of the body. Mild-to-moderate psoriasis is considered to involve up to 20 percent of the body and accounts for approximately 80 percent of the psoriatic patient population. About Retinoids Synthetic retinoids are analogs of Vitamin A vitamin A also called retinol Fat-soluble alcohol, most abundant in fatty fish and especially in fish-liver oils. It is not found in plants, but many vegetables and fruits contain beta-carotene (see , which is thought to play a role in skin cell proliferation and differentiation. While oral retinoids have long been available for the treatment of psoriasis, their side effects Side effects Effects of a proposed project on other parts of the firm. profile has limited their use to patients with severe disease. Earlier topical retinoids, used to treat acne, have shown poor efficacy in psoriasis. Any of the above statements that refer to the Company's estimated or anticipated future results are forward-looking and reflect the Company's current analysis of existing trends and information. Actual results may differ from current expectations based on a number of factors affecting Allergan's businesses, including competitive conditions and changing market conditions, including the performance and acceptance of new products. These forward-looking statements represent the Company's judgment only as of the date of this press release. Actual results could differ materially from those projected in this release. As a result, the reader is cautioned not to rely on these forward-looking statements. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Allergan, Inc., headquartered in Irvine, California, is a technology-driven, global health care company, focused on specialty pharmaceutical products for specific disease areas that deliver value to customers, satisfy unmet medical needs and improve patients' lives. Copies of company press releases and additional information about Allergan are available on our Web Site (http://www.allergan.com), or you can contact our Investor Relations Investor relations The process by which the corporation communicates with its investors. Department by calling 714/246-4636. CONTACT: Allergan, Inc., Irvine Jeff D'Eliscu, 714/246-4636 (office) 714/675-9475 (home) |
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