Duramed Discusses Continued Progress and Growth at Annual Meeting.Business Editors and Health/Medical Writers CINCINNATI--(BUSINESS WIRE)--May 10, 2001 Provides Details On Pipeline Expansion; Announces Shipment of Its Oral Contraceptive Aviane(TM) Into the $130 Million Brand Market Duramed Pharmaceuticals Inc. (Nasdaq:DRMD DRMD Duramed Pharmaceuticals (stock symbol) DRMD Département Romand des Ministères Diaconaux DRMD deployments requirements manning document (US DoD) DRMD Division of Radiation and Medical Devices ) announced today that its chairman and chief executive officer E. Thomas Arington addressed Duramed shareholders at the company's 2001 annual meeting. Arington reviewed the progress the company made in the full year 2000 and in the first quarter of 2001; discussed the approval and shipment of Aviane(TM) (levonorgestrel levonorgestrel /le·vo·nor·ges·trel/ (-nor-jes´trel) the levorotatory form of norgestrel; used as an oral or subdermal contraceptive. le·vo·nor·ges·trel n. and ethinyl estradiol) Tablets, Duramed's new oral contraceptive product; commented on the company's product development efforts; and reviewed its outlook. Also presenting at the meeting were Dr. Raymond Klein, clinical and medical advisor to the chairman, and Kathi Rinesmith, Duramed's vice president of research and development. "We are keeping our corporate promises," Arington said at the beginning of the meeting. "At last year's annual meeting, we stated that our commitments for the year 2000 would be the continued sales growth and market penetration of Cenestin and Apri; key new product approvals by mid year 2001; the continued development of both brand and generic products; improved gross margins; and an improved bottom line. We are pleased to say that our performance is in keeping with those commitments." Improving Financial Condition For the year 2000, Duramed's net sales were $83.5 million, up 66 percent over 1999. Gross profit for 2000 was $35.1 million, up 235 percent from 1999. For the first quarter 2001, the company's net sales totaled $27.3 million, up 64 percent from the first quarter 2000. And gross profit for the quarter was $12.8 million, up 129 percent from the same period last year. The improvements were largely due to the performance of the company's portfolio of hormone products. Hormone products represented 21 percent of revenue in 1999 and 48 percent in 2000. The company believes hormone products will continue to grow strongly and account for 65 percent of net sales in 2001. Arington said, "Our top priority and core business strategy is to provide pharmaceutical products that address female healthcare needs. Duramed's strength and focus continues to be on solid oral dose hormones, where we are developing two separate franchises--hormone replacement therapy and oral contraceptive products. These franchises will continue to be our major revenue drivers." Aviane Shipping Commences Arington also announced that the company began shipping Aviane on May 8, 2001. Aviane is the first and only product deemed bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. to and therapeutically interchangeable with Alesse(TM)(a) for all new and refill prescriptions. According to IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. data for drugstore and non-retail purchases, Alesse sales in 2000 were approximately $130 million, up 35 percent from 1999. "We are excited that Aviane expands our hormone family to six products, and we look forward to the revenues it will produce," Arington continued. "With the success of Apri, our first oral contraceptive, we have proven that we can be very effective in penetrating the oral contraceptive market." Like Apri(R) (desogestrel and ethinyl estradiol) Tablets, Aviane will be marketed as a value brand, meaning that the product can be written as a prescription by physicians and/or substituted for the brand product by pharmacists. Expanding Pipeline Aviane was Duramed's first product approval in 2001. The company has four additional Abbreviated New Drug Applications (ANDAs) on file with the U.S. Food and Drug Administration, including oral contraceptives. In 2001, Duramed expects to submit eight ANDAs to the 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. , five of which are for hormone products. Further, the company has recently signed two agreements with product development companies, and these could produce at least four multi-source, non-hormone products per year beginning in 2002. Duramed also has 11 hormone products in various stages of development. Six of these are for ANDAs, and five are for New Drug Applications (NDAs). The five NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any items, upon successful completion, will expand the Cenestin(R) (synthetic conjugated conjugated adj. Conjugate. estrogens, conjugated Warning - Hazardous drug! C.E.S. estrogens Estrogens Hormones produced by the ovaries, the female sex glands. Mentioned in: Acne, Polycystic Ovary Syndrome estrogens (es´trōjenz), n. , A Tablets) family of products. These items include combining Cenestin with progesterone progesterone (prōjĕs`tərōn'), female sex hormone that induces secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. , with methyltestosterone, and with both progesterone and methyltestosterone. The development work on the Cenestin and progesterone combination product is completed, and that product should be in the clinic within a few weeks. Formal Business In the formal business segment of the meeting, Duramed shareholders ratified the selection of Ernst and Young LLP LLP - Lower Layer Protocol as the company's independent auditors. As members of the 2001 Board of Directors, shareholders reelected members of the 2000 Board and also elected Vernon A. Brunner and Gerald L. Wolken. Brunner is president of Brunner Marketing Solutions and former executive vice president of marketing at Walgreen Co. Wolken is managing partner of MLE MLE Maximum Likelihood Estimation MLE Managed Learning Environment MLE Maximum Likelihood Estimate MLE Medical Laboratory Evaluation (Medical Laboratory Proficiency Testing Program, Washington, DC) Enterprises, Inc., a management consulting firm and former chief executive officer of SupeRx Drug Stores, a spin off of Kroger Co. The web cast will be archived for 90 days at http://www.vcall.com/NASApp/VCall/EventPage?ID=74624. About the Company Duramed Pharmaceuticals, Inc. develops, manufactures and markets prescription drug products. The company's business strategy emphasizes products with attractive market opportunities and potentially limited competition due to technological barriers to entry, focusing on women's health and the hormone replacement therapy Hormone Replacement Therapy Definition Hormone replacement therapy (HRT) is the use of synthetic or natural female hormones to make up for the decline or lack of natural hormones produced in a woman's body. market. The company's mission is to be the premier supplier of solid oral dose hormone products. Duramed's containment manufacturing facility for the production of hormones distinguishes the company from most competitors. The facility incorporates enclosed product flow and state-of-the-art environmental controls to ensure purity, stability, and tablet uniformity for its hormone products. The company's stock is traded on Nasdaq using the symbol DRMD. Additional information about the company can be found on the World Wide Web at www.duramed.com and www.cenestin.com. (a) Alesse is a trademark of Wyeth-Ayerst Laboratories, Inc. Like all estrogen drug products, CENESTIN(R) should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia neoplasia /neo·pla·sia/ (-pla´zhah) the formation of a neoplasm. cervical intraepithelial neoplasia , undiagnosed abnormal genital bleeding, active thrombophlebitis thrombophlebitis: see phlebitis. , or thromboembolic thromboembolic pertaining to or emanating from thromboembolism. thromboembolic meningoencephalitis see hemophilosis. thromboembolic parasitism see thromboembolic colic. disorders. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal post·men·o·paus·al adj. Of or occurring in the time following menopause. postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr women with an intact uterus. The most common adverse events reported in clinical experience with CENESTIN(R) included headache, insomnia, asthenia asthenia /as·the·nia/ (as-the´ne-ah) lack or loss of strength and energy; weakness. neurocirculatory asthenia , nervousness, paresthesia paresthesia /par·es·the·sia/ (par?es-the´zhah) morbid or perverted sensation; an abnormal sensation, as burning, prickling, formication, etc. par·es·the·sia or par·aes·the·sia n. , and depression. For additional information on CENESTIN(R), please see full prescribing information. The Securities and Exchange Commission (SEC) encourages companies to disclose forward-looking information so that investors can better understand a company's future prospects and make informed investment decisions. Due to changing market conditions, product competition, the nature of product development and regulatory approval processes, the achievement of forward-looking statements contained in this press release are subject to risks and uncertainties. For further details and a discussion of these risks and uncertainties, see Duramed's SEC filings, including its annual report on Form 1O-K/A. |
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