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Cenestin Offers Baby Boomer Women A New Plant-Derived Alternative To Horse Urine-Derived Premarin.


CINCINNATI--(BUSINESS WIRE)--Sept. 13, 1999--

Duramed Pharmaceuticals Launches Direct-To-Consumer

Advertising Campaign Promoting Cenestin

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 the debut of its direct-to-consumer national print advertising campaign to promote Cenestin(TM) (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. Cenestin offers women a new plant-derived alternative to horse urine-derived Premarin(R)(1) for the relief of hot flashes and night sweats associated with menopause. Premarin, the most widely prescribed drug in America is a conjugated estrogens product that is made from the urine of pregnant horses. Cenestin, derived 100 percent from soy and yam plants, is the first plant-derived conjugated estrogens product with a slow-release formulation similar to horse urine-derived Premarin. Cenestin will compete with Premarin, offering millions of baby boomer women and their physicians a new, appealing plant-based choice for the treatment of hot flashes and night sweats, the most common symptoms of menopause.

Duramed's print advertising campaign, promoting Cenestin direct-to-consumers and focusing on education and awareness, begins this month with ads appearing in a wide range of national publications including women's service magazines, consumer health publications and prominent news weeklies. Specific titles include Better Homes & Gardens, Family Circle, Good Housekeeping, Ladies Home Journal, McCalls, Woman's Day, More, Prevention, Southern Living, Newsweek, Time and People. The direct-to-consumer national print initiative follows the June launch of Duramed's healthcare professional awareness campaign and July launch of a comprehensive U.S. detailing sales effort.

Educational Program Targets Pro-Active Consumers

"Consumer research indicates that women today take pro-active steps in managing their healthcare. The ad campaign intends to raise awareness of the available choices of estrogen replacement therapy estrogen replacement therapy
n. Abbr. ERT
The administration of estrogen, especially in postmenopausal women, to relieve symptoms and conditions associated with estrogen deficiency, such as hot flashes and osteoporosis.
 focusing on plant-derived Cenestin, which can help relieve symptoms and enable women to better manage their transition through menopause," said Duramed's Senior Vice President of Commercial Operations Jeffrey Arington. "Communicating directly to consumers about Duramed's new conjugated estrogens alternative derived 100 percent from soy and yam plants is an important step in our nationwide outreach effort to educate women about Cenestin and the benefits of estrogen replacement therapy."

In fact, Duramed's direct-to-consumer print ad reflects the attitude and lifestyle of today's menopausal woman. According to Duramed's Director of Brand Marketing, Jeff Kern, the Company's consumer ad targets women seeking relief from menopausal symptoms, offering plant-derived Cenestin as, "a cool choice to relieve the hot flashes of menopause." The ad depicts a confident woman sitting atop an ice cube in a winter setting. The image indicates that today's woman "has an exciting new choice" to help her successfully relieve her menopausal symptoms. Along with a brand icon of a soy leaf frozen inside the ice cube, the advertisement carries the tagline, "Made from plants! Isn't that cool?"

In addition, the Cenestin ad offers consumers the opportunity to learn more about menopause and the benefits of estrogen replacement therapy (ERT ERT
abbr.
estrogen replacement therapy


Estrogen replacement therapy (ERT)
A treatment in which estrogen is used therapeutically during menopause to alleviate certain symptoms such as hot flashes.
). By calling the toll-free telephone number A toll-free, Freecall, Freephone, or 800 number is a special telephone number, in that the called party is charged the cost of the calls by the telephone carrier, instead of the calling party.  (1-877-631-COOL) included in the ad, interested consumers can obtain Duramed's free educational brochure "A Guide to Menopause". Additionally, they can visit Duramed's new Cenestin website at www.cenestin.com to obtain more information.

Cenestin, a prescription only product indicated for the treatment of hot flashes, night sweats and other moderate-to-severe vasomotor vasomotor /vaso·mo·tor/ (-mo´tor)
1. affecting the caliber of blood vessels.

2. a vasomotor agent or nerve.


va·so·mo·tor
adj.
 symptoms associated with menopause was approved for marketing by the U.S. Food and Drug Administration in March 1999. Until Cenestin's approval, horse urine-derived Premarin was the only slow-release conjugated estrogens product on the market. Available nationwide, Cenestin offers women seeking relief from their menopausal symptoms a unique therapeutic alternative derived 100 percent from soy and yam plants.

About the Company, New Applications and Clinical Trials

Duramed Pharmaceuticals 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.

On March 24, 1999, 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.
 approved the Company's first branded product, Cenestin(TM) (synthetic conjugated estrogens, A) Tablets, for the treatment of moderate-to-severe vasomotor symptoms. Shipments of Cenestin began in May and consumers now can have a prescription filled at retail outlets. The Company has initiated a clinical program to evaluate Cenestin for the prevention of osteoporosis. One important element of the program -- the bone marker study that will assess the efficacy of Cenestin in reducing the loss of bone caused by menopause -- has begun, and results are anticipated to be published early next year.

Duramed recently filed an Investigational New Drug (IND) application with the FDA to study the effects of medroxyprogesterone acetate (MPA MPA

medroxyprogesterone acetate.
) administered cyclically in combination with Cenestin. Duramed anticipates the initiation of the related Phase III clinical trials in the coming months and filing the 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  upon their completion.

The Company also successfully completed a clinical study demonstrating the bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability.  of its 1.25 mg strength of Cenestin. The bioequivalence trial compared Duramed's 1.25 mg formulation of Cenestin to two of the approved 0.625 mg strength of Cenestin tablets. The study found these strengths to be dose proportional, essentially identical in rate and extent of absorption of the active ingredients in the bloodstream. On July 29, 1999 the Company filed the supplemental NDA for the 1.25 mg strength of Cenestin and expects to introduce this strength late in 1999, contingent upon approval from the FDA.

With the August 12, 1999 approval of its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar  for Desogestrel and Ethinyl Estradiol 0.15 mg, Duramed entered the oral contraceptive market, expanding its female healthcare product line and its commitment to becoming a leader in women's healthcare. This product is the first and only substitutable equivalent oral contraceptive for Ortho-Cept(R)(2) and Desogen(R)(3) Tablets.

Duramed's containment manufacturing facility for the production of hormones - with enclosed product flow and state-of-the-art environmental controls - ensures purity, stability and tablet uniformity for Cenestin and other hormone products. While Duramed's primary focus will be solid oral dose hormones, the Company's other areas of concentration -- controlled release technology and oncology -- continue to represent attractive market opportunities that will be pursued, as appropriate.

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.

Full prescribing information available upon request. (1) Premarin is a registered trademark of Wyeth-Ayerst Laboratories,

Inc. (2) Ortho-Cept is a registered trademark of R.W. Johnson

Pharmaceutical, Inc. (3) Desogen is a registered trademark of Organon or·ga·non or or·ga·num
n. pl. or·ga·nons or or·ga·nums or or·ga·na
1. An organ.

2. A set of principles for use in scientific investigation.



organon

pl. organa [Gr.] organ.
 Pharmaceutical, Inc.

Like all estrogen drug products, Cenestin 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 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.

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 10-K/A.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 13, 1999
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