Inspire Pharmaceuticals, Inc. Provides Update on Phase II Trial of INS365 Respiratory for Chronic Bronchitis

Apr 24, 2001, 01:00 ET from Inspire Pharmaceuticals, Inc.

    DURHAM, N.C., April 24 /PRNewswire Interactive News Release/ --
 Inspire Pharmaceuticals, Inc. (Nasdaq:   ISPH) announced today a decision to
 temporarily suspend enrollment of new patients in the double-blind,
 placebo-controlled, multicenter Phase II trial of INS365 Respiratory for
 chronic bronchitis, in order to further evaluate the protocol design.  All
 patients currently enrolled in the trial will continue to receive INS365
 Respiratory or placebo through completion of the study.
     "We are working closely with Genentech to analyze and review the protocol
 design and data from patients currently enrolled in the trial.  This analysis
 is intended to provide information that will ensure optimal design and conduct
 of the remainder of the Phase II program.  We are keeping the FDA
 well-informed," said Don Kellerman, Pharm.D., Senior Vice President of
 Development at Inspire.
     Inspire and Genentech have an ongoing collaboration to develop treatments
 for respiratory disorders with significant unmet medical need, including
 chronic bronchitis, cystic fibrosis and sinusitis.  In addition to the chronic
 bronchitis clinical program, an initial Phase I study of INS37217 Respiratory
 for the treatment of cystic fibrosis has been completed.
     Chronic bronchitis is a serious and potentially life-threatening lung
 disease caused primarily by environmental factors such as smoking and
 pollution.  It involves excessive retention of mucus as well as inflamed
 airways leading to impaired mucociliary clearance causing patients to
 experience frequent respiratory infections.  In the United States there are
 approximately 13 million patients diagnosed with chronic bronchitis.  If left
 untreated, these patients experience progressive deterioration in lung
 function that can eventually result in respiratory failure and death.  It is
 the fourth leading cause of death in the United States with increasing rates
 of morbidity and mortality.
     Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat
 diseases characterized by deficiencies in the body's innate defense mechanisms
 of mucosal hydration and mucociliary clearance, as well as other non-mucosal
 disorders.  Mucosal defense mechanisms are the natural way that the body
 defends its mucosal surfaces against dust, pollutants, bacteria and viruses.
 Inspire's lead product candidates target respiratory and ophthalmic diseases
 with inadequate current treatments and which represent large therapeutic
 market opportunities.  Inspire has four product candidates in clinical
 development, and has entered into development and commercialization alliances
 with Genentech, Inc., Kissei Pharmaceutical Co., Ltd., Santen Pharmaceutical
 Co., Ltd. and Kirin Brewery Co., Ltd. Inspire's products are based on
 proprietary technology relating to P2Y receptors.  Inspire is exploring other
 target diseases where it believes P2Y receptors play important biological
 roles.
 
     The forward-looking statements in this news release relating to
 management's expectations and beliefs are based on preliminary information and
 management assumptions.  Such forward-looking statements are subject to a wide
 range of risks and uncertainties that could cause results to differ in
 material respects, including those relating to product development, revenue
 and earnings expectations, intellectual property rights and litigation,
 competitive products, results of clinical trials, the need for additional
 research and testing, delays in manufacturing, funding, and the timing and
 content of decisions made by regulatory authorities, including the U.S. Food
 and Drug Administration.  Further information regarding factors that could
 affect the Company's results is included in the Company's filings with the
 Securities and Exchange Commission.  The Company undertakes no obligation to
 publicly release the results of any revisions to these forward-looking
 statements that may be made to reflect events or circumstances after the date
 hereof to reflect the occurrence of unanticipated events.
 
      Inspire Pharmaceuticals, Inc.
      Mary Bennett
      Vice President, Operations & Communications
      (919) 941-9777, Extension 245
 
      Noonan/Russo Media Contact:
      Emily Poe (212) 696-4455
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X31029625
 
 

SOURCE Inspire Pharmaceuticals, Inc.
    DURHAM, N.C., April 24 /PRNewswire Interactive News Release/ --
 Inspire Pharmaceuticals, Inc. (Nasdaq:   ISPH) announced today a decision to
 temporarily suspend enrollment of new patients in the double-blind,
 placebo-controlled, multicenter Phase II trial of INS365 Respiratory for
 chronic bronchitis, in order to further evaluate the protocol design.  All
 patients currently enrolled in the trial will continue to receive INS365
 Respiratory or placebo through completion of the study.
     "We are working closely with Genentech to analyze and review the protocol
 design and data from patients currently enrolled in the trial.  This analysis
 is intended to provide information that will ensure optimal design and conduct
 of the remainder of the Phase II program.  We are keeping the FDA
 well-informed," said Don Kellerman, Pharm.D., Senior Vice President of
 Development at Inspire.
     Inspire and Genentech have an ongoing collaboration to develop treatments
 for respiratory disorders with significant unmet medical need, including
 chronic bronchitis, cystic fibrosis and sinusitis.  In addition to the chronic
 bronchitis clinical program, an initial Phase I study of INS37217 Respiratory
 for the treatment of cystic fibrosis has been completed.
     Chronic bronchitis is a serious and potentially life-threatening lung
 disease caused primarily by environmental factors such as smoking and
 pollution.  It involves excessive retention of mucus as well as inflamed
 airways leading to impaired mucociliary clearance causing patients to
 experience frequent respiratory infections.  In the United States there are
 approximately 13 million patients diagnosed with chronic bronchitis.  If left
 untreated, these patients experience progressive deterioration in lung
 function that can eventually result in respiratory failure and death.  It is
 the fourth leading cause of death in the United States with increasing rates
 of morbidity and mortality.
     Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat
 diseases characterized by deficiencies in the body's innate defense mechanisms
 of mucosal hydration and mucociliary clearance, as well as other non-mucosal
 disorders.  Mucosal defense mechanisms are the natural way that the body
 defends its mucosal surfaces against dust, pollutants, bacteria and viruses.
 Inspire's lead product candidates target respiratory and ophthalmic diseases
 with inadequate current treatments and which represent large therapeutic
 market opportunities.  Inspire has four product candidates in clinical
 development, and has entered into development and commercialization alliances
 with Genentech, Inc., Kissei Pharmaceutical Co., Ltd., Santen Pharmaceutical
 Co., Ltd. and Kirin Brewery Co., Ltd. Inspire's products are based on
 proprietary technology relating to P2Y receptors.  Inspire is exploring other
 target diseases where it believes P2Y receptors play important biological
 roles.
 
     The forward-looking statements in this news release relating to
 management's expectations and beliefs are based on preliminary information and
 management assumptions.  Such forward-looking statements are subject to a wide
 range of risks and uncertainties that could cause results to differ in
 material respects, including those relating to product development, revenue
 and earnings expectations, intellectual property rights and litigation,
 competitive products, results of clinical trials, the need for additional
 research and testing, delays in manufacturing, funding, and the timing and
 content of decisions made by regulatory authorities, including the U.S. Food
 and Drug Administration.  Further information regarding factors that could
 affect the Company's results is included in the Company's filings with the
 Securities and Exchange Commission.  The Company undertakes no obligation to
 publicly release the results of any revisions to these forward-looking
 statements that may be made to reflect events or circumstances after the date
 hereof to reflect the occurrence of unanticipated events.
 
      Inspire Pharmaceuticals, Inc.
      Mary Bennett
      Vice President, Operations & Communications
      (919) 941-9777, Extension 245
 
      Noonan/Russo Media Contact:
      Emily Poe (212) 696-4455
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X31029625
 
 SOURCE  Inspire Pharmaceuticals, Inc.