Chattem, Inc. Announces Results of Review of Active Ingredient in Dexatrim.Business Editors CHATTANOOGA, Tenn.--(BUSINESS WIRE)--Oct. 20, 2000 Chattem, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CHTT), a leading marketer and manufacturer of branded consumer products, announced today that a Nonprescription non·pre·scrip·tion adj. Sold legally without a physician's prescription; over-the-counter. Drugs Advisory Committee commissioned by the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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 review the safety of phenylpropanolamine phenylpropanolamine /phen·yl·pro·pa·nol·amine/ (-pro?pah-nol´ah-men) an adrenergic, used in the form of the hydrochloride salt as a nasal and sinus decongestant, as an appetite suppressant, and in the treatment of stress incontinence. (PPA PPA 1. Palpation, Percussion & Ausculation 2. Pittsburgh pneumonia agent 3. Postpartum amenorrhea 4. Price per accession 5. Pure pulmonary atresia ), the active ingredient in the Company's Dexatrim brand, has determined that PPA is not considered safe for use as an appetite suppressant Appetite suppressant Drug that decreases feelings of hunger. Most work by increasing levels of serotonin or catecholamine, chemicals in the brain that control appetite. . The recommendation of the committee now goes to the FDA for consideration. The committee made the identical recommendation with respect to the use of PPA in decongestants Decongestants Definition Decongestants are medicines used to relieve nasal congestion (stuffy nose). Purpose A congested or stuffy nose is a common symptom of colds and allergies. , which affects certain formulations of such popular over-the-counter brands as Alka Seltzer, Contac, Dimetapp, Robitussin and Triaminic. The committee's findings relied mainly upon an epidemiology study of hemorrhagic stroke and PPA conducted by Yale University, which found an association between PPA use and hemorrhagic stroke, despite being based on only 6 cases of exposure to appetite suppressants out of 706 stroke cases enrolled. An independent panel of leading epidemiology experts, commissioned by the Consumer Healthcare Products Association, reviewed the study's results and determined its results were inconclusive because, among other things, the small number of reported cases and other intervening factors, such as alcohol and tobacco use by and pre-existing hypertension in the six stroke patients who reported a probable use of a PPA-based diet suppressant within three days of stroke onset. The Company intends to work with the FDA on next steps regarding the PPA study, which could include product reformulation or product discontinuation of Dexatrim with PPA. The timing of any further action is unknown at this time. Dexatrim's sales in the fiscal year ending November 30, 2000 will be approximately $30 million, of which approximately $10 million will come from Dexatrim Natural, which was launched December 1, 1999 and does not contain PPA. The Company also plans to launch Dexatrim Natural Ephedrine-Free January 1, 2001 together with a new 90-count bottle of both forms of Dexatrim Natural. The financial impact of yesterday's decision is uncertain until the result of any subsequent FDA action is known. However, Dexatrim with PPA was expected to contribute approximately $8 million in EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) A metric used to show a company's profitability, but not its cash flow. EBITDA became popular in the 1980s to show the potential profitability of leveraged buyouts, but has become and $.40-$.50 per share in earnings in fiscal 2001. The Company previously projected 2001 net sales of $205-220 million, EBITDA of $47-50 million and earnings per share of $1.00-$1.20. Statements concerning the impact of governmental regulations, the Company's business outlook, anticipated profitability, sales or expenses and sales growth, together with other statements made in this press release that are not historical facts are "forward looking statements" as that term is defined under the federal securities laws. All forward looking statements are subject to the risks and uncertainties which could cause actual outcomes and results to differ materially from those expressed or projected, including those described in the Company's filings with the Securities and Exchange Commission. |
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