Take alook at this
Cenestin(TM), The New Plant-Derived Synthetic Complex
Mixture Conjugated Estrogens, Approved for Marketing by
FDA
PR Newswire - March 25, 1999 08:44
Gives Freedom of Choice to Menopausal Women and Baby Boomers Now Entering Menopause
Seeking the Benefits of Conjugated Estrogens Replacement Therapy
CINCINNATI, March 25 /PRNewswire/ -- Duramed Pharmaceuticals, Inc. (Nasdaq: DRMD) today
announced that the United States Food and Drug Administration (FDA) has granted the company
approval to market Cenestin(TM) (synthetic conjugated estrogens, A) Tablets, the new plant-derived
synthetic complex mixture conjugated estrogens product for the treatment of hot flashes, night sweats
and other moderate-to-severe vasomotor symptoms associated with menopause. Cenestin, synthesized
100% from soy and yam plants, will be available by prescription within 90 days in two dosage strengths
-- 0.625 mg and 0.9 mg.
According to Duramed Chairman and Chief Executive Officer E. Thomas Arington, "With the approval
of Cenestin, millions of menopausal women, along with the millions more Baby Boomers soon to enter
menopause, will have a new plant-derived choice in conjugated estrogens products for the treatment of
vasomotor symptoms associated with menopause, such as hot flashes and night sweats."
For the past 56 years, the only complex mixture conjugated estrogens product women could choose
has been one derived from pregnant mares' urine.
Dr. Florence Comite, founder, Women's Health at Yale and Associate Clinical Professor, Yale
University School of Medicine said, "Women today are approaching menopause as a natural transition.
They have a great deal of information and seek to make decisions that are affecting their bodies in
partnership with their physicians. They like to better understand why they are taking a prescription and
the source of the medication. Having a new plant-derived estrogen allows the physician the ability to
tailor the specific medication to the individual woman's preference."
Estrogen Replacement Therapy (ERT)/Hormone Replacement Therapy (HRT)
Market Growth Outlook Driven by Baby Boomers
The average age of American women at menopause is 51. According to the
American College of Obstetricians and Gynecologists (ACOG), the first wave of
Baby Boomer women (born 1945-1960) are now entering menopause and another
20 million more will reach menopause in the next decade. Currently, over
40 million women in the U.S. are over 50 and eligible to take either ERT
(estrogen only) or HRT (estrogen with a progestin).
The combined ERT/HRT market is over $2 billion in the U.S. alone with a
projected growth rate of 15% according to NDC Health Information Services, a
Phoenix-based pharmaceutical market data provider.
Cenestin Clinical Trials
Cenestin was shown to be safe and effective in a double-blind, placebo- controlled, randomized
twelve-week clinical trial of 120 women, chosen with minimal restriction to race, maximum weight and
time into menopause. Cenestin was well tolerated. The most frequently reported adverse events were
headache and insomnia, which occurred with similar frequency in the placebo group. There was a
statistically significant reduction in the number of moderate-to- severe hot flashes at four weeks in the
Cenestin group versus the placebo group.
Risks and Precautions
The risks and precautions associated with all ERT products include:
-- ERT should not be administered during known or suspected pregnancy.
There is an increased risk of endometrial cancer connected with ERT.
In women with an intact uterus, ERT should be accompanied by
administration of progestin to decrease this risk.
-- ERT should not be administered to women diagnosed with, or at
significant risk of, certain cardiovascular disorders.
-- ERT should not be administered to women presenting undiagnosed genital
bleeding or estrogen dependent neoplasia.
-- ERT should not be administered to women with known or suspected cancer
of the breast.
Duramed Pursuing Market Leadership in Women's Health Through a Family of
Hormone Products
Cenestin is the first brand product for which Duramed has received FDA
approval and its launch is the first step in Duramed's long-term program to
build a family of hormone products. Arington commented, "Duramed is focused
on a product development plan designed to make the company a leader in women's
healthcare and the hormone replacement therapy market. The approval of
Cenestin for the treatment of vasomotor symptoms is a significant step toward
that objective. Based on our assessment of the $1.4 billion U.S. ERT market,
we believe Cenestin has the potential to become a market leader. With the
first plant-derived synthetic complex mixture conjugated estrogens and a
focused and aggressive marketing plan, our goal is to achieve an annualized
sales rate for Cenestin in excess of $100 million within 15-18 months after
the product is launched."
Duramed recently filed an Investigational New Drug (IND) application with
the FDA to study the effects of medroxyprogesterone acetate (MPA) administered
cyclically in combination with Cenestin.
Duramed anticipates initiating the related Phase III clinical trials in
the coming months and filing the NDA upon completion of those trials. The
company will be initiating a clinical program to evaluate Cenestin in
additional dosage strengths and for the treatment of osteoporosis. Further,
the company has three Abbreviated New Drug Applications (ANDAs) for hormone
products currently pending with the FDA and an active product development
pipeline. |
