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Cenestin, Synthetic Conjugated Estrogens, A, a Plant-Derived Alternative to Premarin, Now Available for Menopausal Women Seeking Symptom Relief.


CINCINNATI--(BUSINESS WIRE)--July 20, 1999--

Duramed Pharmaceuticals Offers Women a New Choice in

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.
 

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 Cenestin(TM), for the treatment of hot flashes hot flashes Hot flush Gynecology A symptom afflicting 80-85% of middle-aged ♀, first occurring during the perimenopause, continuing with ↓ intensity for yrs, manifesting itself as transient waves of erythema and uncomfortable warmth beginning in the , 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, is now available by prescription. Cenestin offers women seeking relief from their menopausal symptoms a unique therapeutic alternative. Today's menopausal women can now choose Cenestin, a slow-release conjugated estrogens product that is synthesized 100% from soy and yam plants, rather than Premarin(R)(a), which is derived from pregnant horses' urine. Until the approval of Cenestin, Premarin was the only slow-release conjugated estrogens product available.

"We are pleased to bring a new plant-derived choice to the millions of women considering 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.
 or HRT HRT
abbr.
hormone replacement therapy


Hormone replacement therapy (HRT)
Also called estrogen replacement therapy, this controversial treatment is used to relieve the discomforts of menopause.
 to help relieve the symptoms associated with menopause," said Duramed Chairman and Chief Executive Officer E. Thomas Arington. "Since obtaining approval for marketing from 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.
, we have received a significant response from consumers as well as favorable reports of prescriptions written prior to any promotional efforts."

To accommodate this growing interest from both the patient and medical communities, Duramed began shipping Cenestin nationwide four weeks ahead of schedule. Underscoring Duramed's commitment to women's healthcare, the company also plans to initiate a national patient education program focusing on the benefits of ERT and the development of a series of educational tools including a patient brochure entitled "A Guide to Menopause" and an educational website providing product information at www.cenestin.com. Duramed will also begin a variety of promotional initiatives to support Cenestin's on-shelf availability, communicating with both healthcare professionals and consumers. Following a nationwide sales effort, providing members of the medical community with product information and various tools for patient education, consumers can expect Duramed to begin a national print advertising campaign to educate them regarding the choices available for the relief of their menopausal symptoms, classifying Cenestin as the newly-approved, unique, plant-derived option.

"Women today want to understand the source of the drugs they are prescribed and want to participate in deciding their choice of therapy. Now, with the availability of Cenestin, healthcare providers will be better able to tailor treatment regimens based on their patients' preferences," said Duramed Pharmaceuticals' Director of Brand Marketing Jeff Kern. "We expect that our direct-to-consumer advertising direct-to-consumer advertising Drug industry The use of mass media–eg, TV, magazines, newspapers, to publicly promote drugs, medical devices or other products which, by law, require a prescription, which targets consumers, with the intent of having a Pt  campaign will help women better understand their options in choosing a conjugated estrogens product based on preference for plant-derived products versus products extracted from animal waste."

Dr. David Williams, a fellow of the American College of Obstetricians and Gynecologists The American College of Obstetricians and Gynecologists (ACOG) is a professional association of medical doctors specializing in obstetrics and gynecology in the United States. It has a membership of over 49,000[1] and represents 90 percent of U.S.  as well as a registered pharmacist based in Oxford, MS, commented, "I discuss all treatment options with my patients who are interested in ERT to relieve such menopausal symptoms as night sweats and hot flashes. I found that many choose Cenestin after learning that its estrogens come from plant sources and are not extracted from animal waste."

Cenestin is indicated for the treatment of vasomotor symptoms (such as hot flashes and night sweats) associated with menopause. As with any prescription drug prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug,  therapy, some women may experience side effects when taking estrogens. In the Cenestin clinical trial, the most frequently reported adverse events were headache and insomnia, which occurred with similar frequency in the placebo group. Pregnant women should not use 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.
 because of possible risk to the fetus. Women should discuss personal or family history of breast cancer, breast lumps, abnormal vaginal bleeding, and abnormal blood clotting with a healthcare provider. If a woman has had a hysterectomy hysterectomy (hĭstərĕk`təmē), surgical removal of the uterus. A hysterectomy may involve removal of the uterus only or additional removal of the cervix (base of the uterus), fallopian tubes (salpingectomy), and ovaries , taking estrogen alone may increase chance for uterine cancer. Adding a progestogen progestogen /pro·ges·to·gen/ (-jes´tah-jen) progestational agent.

pro·ges·to·gen
n.
Any of various substances having progestational effects; a progestin.
 lowers this risk significantly.

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, and focuses on women's health and the hormone replacement therapy market.

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 will also be initiating a clinical program to evaluate Cenestin in additional dosage strengths and for the prevention of osteoporosis. One important element of these clinical trials, the bone marker study that will assess the rate at which the estrogens in Cenestin are absorbed into bone tissue, has begun, and some results may be published next year.

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

Additional information about the company can be found on the World Wide Web at www.duramed.com.

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

Inc.

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.
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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Geographic Code:1USA
Date:Jul 20, 1999
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