To: vestor who wrote (841 ) 11/23/1998 11:03:00 PM From: Doug Bean Read Replies (2) | Respond to
Vestor:
i don't know if you caught thisor not ,, but it looks like it should help the cause.
Doug
Most Recent Press Release
November 19, 1998
Estrogen Replacement Therapy Is Similarly Efficacious Regardless of
Race or Body Weight
* Duramed Pharmaceuticals Synthetic Conjugated Estrogens Clinical Trial
Provides New Evidence
* Unique Clinical Study Design Reflects Duramed¹s Commitment to Market
Leadership
Cincinnati, November 19, 1998 Duramed Pharmaceuticals, Inc.
(Nasdaq:DRMD) announced, in conjunction with Phoenix International Life
Sciences, Inc. and MDS Harris, that the company has identified
additional information regarding the treatment of postmenopausal
vasomotor symptoms in women regardless of race or body weight. The addi
tional information is based on the successful results of Duramed¹s
multi-center, double-blind, placebo-controlled trial to evaluate its
synthetic conjugated estrogens product in the treatment of
postmenopausal vasomotor symptoms.
At the 1998 annual meeting of the American Association of Pharmaceutical
Sciences, Duramed, Phoenix International and MDS Harris presented the
results of the clinical trial as evidence that African-Americans and
Caucasians experienced a similar response to treatment by estrogen
replacement therapy (ERT) for postmenopausal vasomotor symptoms. The
study of 120 postmenopausal women, of which 28 percent were
African-American, 68 percent were Caucasian and 4 percent were other
races, showed that after 12 weeks of treatment with Duramed¹s synthetic
conjugated estrogens product, there were no statistically significant
differences in response between races. The majority of previously
reported studies do not furnish statistically meaningful information on
the vasomotor effects of ERT on African-Americans, since they have been
limited largely to the study of Caucasians.
Additionally, the Duramed study demonstrated that women with normal and
higher than normal body mass experienced similar relief from their
symptoms. Duramed¹s study included women whose weight ranged from 109
271 pounds; the response to ERT or placebo was similar regardless of
weight.
E. Thomas Arington, Duramed Chairman and Chief Executive Officer,
commented, "We are honored that the American Association of
Pharmaceutical Sciences chose this scientific paper as one to be
presented orally at their 1998 annual meeting. The unique clinical
design of our study reflects Duramed¹s commitment to providing
scientific leadership in the development of hormone replacement
therapies. The study not only contains significant new information but,
as importantly, it employs a research design to better focus on segments
of America¹s female population that, too often, are ignored in
scientific studies."
Arington noted that the referenced study provided Duramed with the
clinical data that constituted the basis for the March 1998 filing of a
New Drug Application (NDA) with the Food and Drug Administration (FDA)
for its synthetic conjugated estrogens product, which will be marketed
under the brand name Cenestinä following FDA approval. The company
believes that the results from the clinical trial were statistically
significant in the reduction of hot flashes and other vasomotor symptoms
in postmenopausal women.
About the Study Participants
Phoenix International Life Sciences Inc. is a Cincinnati-based contract
research organization (CRO) which conducts drug development research for
the pharmaceutical and biotechnology industries. MDS Harris is a
division of MDS, a health and life sciences company whose products and
services are used in the prevention, diagnosis and management of illness
and disease. MDS Harris provides clinical trial services and contract
research as a part of MDS Pharmaceutical Services, providing
comprehensive services for the world's pharmaceutical and biotechnology
industries.
About the Company
Duramed Pharmaceuticals, Inc. currently develops, manufactures and
markets prescription drug products. The Company¹s product development
program is focused on hormonal therapies and controlled release
technology. Since the beginning of 1997, Duramed has received approval
from the FDA for eight Abbreviated New Drug Applications (ANDAs) for
products developed by the Company or in conjunction with development
partners with a number of additional ANDAs presently on file. On March
30, 1998, the Company submitted its first New Drug Application (NDA),
for its synthetic conjugated estrogens product; on June 15, 1998,
Duramed announced that the FDA had completed its preliminary review of
the product. When approved by the FDA, the product will be marketed
under the brand name Cenestin. The worldwide estrogen replacement market
is approaching $2 billion and growing at a rate of 15% per year.
