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)



Apr 26, 2001, 01:00 ET from MIICRO, Inc.

    CHICAGO, April 26 /PRNewswire/ -- 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.
 
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X86533658
 
 

SOURCE MIICRO, Inc.
    CHICAGO, April 26 /PRNewswire/ -- 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.
 
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X86533658
 
 SOURCE  MIICRO, Inc.