MIICRO, Inc. Signs Agreement with Duramed Pharmaceuticals, Inc. to
Evaluate CNS Effects of Cenestin(R) and Prometrium(R) MIICRO's Neuroimaging
Study Will Assess The Potential Cognitive Benefit Of The Combined Therapy pf
Cenestin(R) and Prometrium(R)
CHICAGO, Apr 26, 2001 /PRNewswire via COMTEX/ -- MIICRO, Inc. announced today
that it has signed a contract with Duramed Pharmaceuticals, Inc. to conduct a
neuroimaging study to assess the central nervous system effects of Duramed's
Cenestin(R) (synthetic conjugated estrogens, A) Tablets when combined with
Solvay Pharmaceutical's Prometrium(R). This combination will be compared to the
central nervous system effects of another marketed estrogen replacement
combination drug, with a focus upon the drugs' comparative ability to protect
brain function.
Cenestin(R) is a plant-derived estrogen replacement product and Prometrium(R) is
a micronized formulation of the natural hormone progesterone. These products are
often combined in the treatment of symptoms associated with menopause. It has
been shown that estrogens taken alone can increase a woman's risk of endometrial
cancer, while progestogens can protect the endometrium from the stimulatory
effect of estrogen. For that reason, women with an intact uterus typically use a
combined treatment of estrogens and a progestogen. Research suggests that
estrogens may also play an important role in protecting the brain against the
effects of aging. These studies suggest that the choice of progestogen may be
important; some progestogens have been shown to attenuate these potentially
protective effects of estrogen on the brain. Preclinical data suggests that
Prometrium(R) (natural progesterone), will not have the same negative effect as
other progestogens.
"We're very pleased to be working with Duramed, a leader in women's health and
hormone replacement therapy," said Dawn Matthews, President and CEO of MIICRO,
Inc. "We believe that our technology will provide valuable insights into the CNS
effect and possible new applications of Duramed's estrogen replacement therapy,
with potential benefit to a very broad population."
"This study is the first to evaluate the direct tissue effects in the brain of
conjugated estrogens and micronized progesterone," said Malcolm Cooper, Medical
Director of MIICRO, Inc. "It will provide Duramed with an opportunity to
quantitatively compare Cenestin(R) and Prometrium(R) to an alternative estrogen
replacement therapy. This may be an important step toward understanding the role
of hormone replacement therapy in protection against cognitive dysfunctions such
as Alzheimer's disease."
"An increasing body of scientific literature supports the role of estrogens in
potentially providing cognitive benefit to postmenopausal women," said Raymond
Klein, M.D., Advisor to the Chairman, Clinical and Medical Affairs at Duramed,
Inc. "Although this area remains controversial, a great deal of scientific
interest and research has begun to evaluate the impact of estrogens on the
prevention of dementias, and Alzheimer's disease related to aging. The
clinician's choice of specific estrogen products and progestogen products
becomes even more important, as we evaluate the basic science of these CNS
disorders. We believe, based upon preliminary biological models, that natural
progesterone will support the benefits of Cenestin(R) in this investigational
model."
The worldwide estrogen replacement market is approaching $2.5 billion and
growing at a 15 percent annual rate. MIICRO is the first and only company to
show the direct effects of estrogens on brain glucose metabolism using
neuroimaging. That study, conducted in 1999, compared Wyeth-Ayerst's Premarin(R)
(conjugated estrogens, USP) and Eli Lilly's Evista(R) (a selective estrogen
receptor modulator).
MIICRO, Inc. is a privately held company that has developed a proprietary method
for identifying and measuring the effects of drugs on the central nervous
system. This method enables the quantitative assessment of drug effects on the
brain, and can reduce development costs, speed pharmaceutical compounds to
market, and contribute to improved therapeutics. MIICRO is committed to
improving the quality of life by advancing the understanding of brain-behavior
relationships. To date, MIICRO's technology has been used by Eli Lilly, American
Home Products, Pfizer, and Solvay Pharmaceuticals.
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 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 .
This press release contains forward-looking statements that involve a high
degree of technological, regulatory, and competitive risks and uncertainties
inherent in early stage healthcare companies.
Like all estrogen drug products, CENESTIN(R), and ESTRATEST(R)/ESTRATEST(R) H.S.
Brand Tablets should not be used in women with known or suspected pregnancy,
breast cancer, or estrogen-dependent neoplasia, undiagnosed abnormal genital
bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have
been reported to increase the risk of endometrial carcinoma in postmenopausal
women with an intact uterus. The most common adverse events reported in clinical
experience with CENESTIN included headache, insomnia, asthenia, nervousness,
paresthesia, and depression. The most common adverse events reported with
ESTRATEST/ESTRATEST H.S. Brand Tablets included those typical of estrogen
therapy (such as breast tenderness, headache, nausea, edema and abdominal pain)
and of androgen treatment (including hair loss, acne and hirsutism). Common side
effects of PROMETRIUM(R) Capsules are breast tenderness, dizziness, abdominal
bloating, and vaginal discharge. For additional information on CENESTIN,
ESTRATEST Brand Tablets or PROMETRIUM Capsules, please see full prescribing
information.
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SOURCE MIICRO, Inc.
CONTACT: Kelly Hodges of MIICRO, 312-602-5511
(DRMD) |
