Sheffield Pharmaceuticals Submits an Investigational New Drug Application For Budesonide Inhalation Suspension

Apr 04, 2001, 01:00 ET from Sheffield Pharmaceuticals, Inc.

    ST. LOUIS, April 4 /PRNewswire/ -- Sheffield Pharmaceuticals, Inc.
 (Amex:   SHM) today announced that an Investigational New Drug Application (IND)
 has been submitted to the U.S. Food and Drug Administration for budesonide
 inhalation suspension for delivery via a standard commercial nebulizer.  This
 IND will allow Sheffield to initiate clinical studies of this unit-dose
 packaged form of budesonide in the United States.
     The budesonide inhalation product to be studied under this IND results
 from formulation work conducted by Sheffield's subsidiary, Respiratory Steroid
 Delivery, Ltd. (RSD).  The formulation technology utilized was licensed by RSD
 from Elan Corporation and employs Elan's novel NanoCrystal(TM) dispersion
 technology.  It is anticipated that budesonide formulated utilizing this
 technology will result in a product that will have a superior pharmaceutical
 and clinical profile when administered via inhalation.
     Budesonide is an anti-inflammatory corticosteroid indicated for the
 maintenance treatment of asthma as well as prophylactic therapy for this
 condition.  In all delivery forms, budesonide sales were approximately
 $700 million on a worldwide basis in 1999.  Asthma affects approximately 17
 million Americans, 5 million of whom are children.  Currently, there is only
 one budesonide product available in nebulized form in the United States.
     "We are excited to initiate a clinical development program on unit-dose
 budesonide.  Budesonide is the leading asthma treatment in Europe and we
 believe that it has similar potential in the U.S.  The National Institutes of
 Health's 1997 Expert Panel Report II on the Diagnosis and Management of Asthma
 considered inhaled corticosteriods such as budesonide to be the most effective
 anti-inflammatory therapy today for the control of persistent asthma.
 Budesonide, in unit-dose form, recently received approval in the U.S. for
 inhaled use in asthma patients as young as twelve months of age.  We believe a
 significant commercial opportunity exists since this is the only inhaled
 steroid approved for use in children younger than four years.  This recently
 approved product is also the only steroid available in the U.S. for delivery
 through a standard nebulizer and commands a premium price.  As a result, we
 believe that the commercial potential for Sheffield's budesonide inhalation
 suspension is significant," said Loren Peterson, Sheffield's president and
 chief executive officer.
     Sheffield Pharmaceuticals, Inc. is a specialty pharmaceutical company
 focused on the development and commercialization of later stage, lower risk
 pharmaceutical opportunities, particularly those utilizing unique pulmonary
 delivery technologies over a range of therapeutic areas.  Sheffield has
 strategic alliances for pulmonary delivery development with Elan Corporation
 plc, Siemens AG and Zambon Group SpA. Investors can learn more about Sheffield
 Pharmaceuticals on its web site at www.sheffieldpharm.com .
 
     This press release contains certain forward-looking statements within the
 meaning of Section 27A of the Securities Act of 1933, as amended, and Section
 21E of the Securities Exchange Act of 1934, as amended, which are intended to
 be covered by the safe harbors created thereby.  Investors are cautioned that
 all forward-looking statements involve risks and uncertainty.  Although the
 Company believes that the assumptions underlying the forward-looking
 statements contained herein are reasonable, any of the assumptions could be
 inaccurate, and therefore, there can be no assurance that the forward-looking
 statements included in this press release will prove to be accurate.
 Important factors that could cause actual results to differ materially from
 the forward-looking statements include the Company's need to obtain
 substantial additional capital (through financings or otherwise) to fund its
 operations and the progress of development, government and regulatory
 approvals and licensing/commercialization of the Company's technologies.  In
 light of the significant uncertainties inherent in the forward-looking
 statements included herein, the inclusion of such information should not be
 regarded as a representation by the Company or any other person that the
 objectives and plans of the Company will be achieved.
 
 

SOURCE Sheffield Pharmaceuticals, Inc.
    ST. LOUIS, April 4 /PRNewswire/ -- Sheffield Pharmaceuticals, Inc.
 (Amex:   SHM) today announced that an Investigational New Drug Application (IND)
 has been submitted to the U.S. Food and Drug Administration for budesonide
 inhalation suspension for delivery via a standard commercial nebulizer.  This
 IND will allow Sheffield to initiate clinical studies of this unit-dose
 packaged form of budesonide in the United States.
     The budesonide inhalation product to be studied under this IND results
 from formulation work conducted by Sheffield's subsidiary, Respiratory Steroid
 Delivery, Ltd. (RSD).  The formulation technology utilized was licensed by RSD
 from Elan Corporation and employs Elan's novel NanoCrystal(TM) dispersion
 technology.  It is anticipated that budesonide formulated utilizing this
 technology will result in a product that will have a superior pharmaceutical
 and clinical profile when administered via inhalation.
     Budesonide is an anti-inflammatory corticosteroid indicated for the
 maintenance treatment of asthma as well as prophylactic therapy for this
 condition.  In all delivery forms, budesonide sales were approximately
 $700 million on a worldwide basis in 1999.  Asthma affects approximately 17
 million Americans, 5 million of whom are children.  Currently, there is only
 one budesonide product available in nebulized form in the United States.
     "We are excited to initiate a clinical development program on unit-dose
 budesonide.  Budesonide is the leading asthma treatment in Europe and we
 believe that it has similar potential in the U.S.  The National Institutes of
 Health's 1997 Expert Panel Report II on the Diagnosis and Management of Asthma
 considered inhaled corticosteriods such as budesonide to be the most effective
 anti-inflammatory therapy today for the control of persistent asthma.
 Budesonide, in unit-dose form, recently received approval in the U.S. for
 inhaled use in asthma patients as young as twelve months of age.  We believe a
 significant commercial opportunity exists since this is the only inhaled
 steroid approved for use in children younger than four years.  This recently
 approved product is also the only steroid available in the U.S. for delivery
 through a standard nebulizer and commands a premium price.  As a result, we
 believe that the commercial potential for Sheffield's budesonide inhalation
 suspension is significant," said Loren Peterson, Sheffield's president and
 chief executive officer.
     Sheffield Pharmaceuticals, Inc. is a specialty pharmaceutical company
 focused on the development and commercialization of later stage, lower risk
 pharmaceutical opportunities, particularly those utilizing unique pulmonary
 delivery technologies over a range of therapeutic areas.  Sheffield has
 strategic alliances for pulmonary delivery development with Elan Corporation
 plc, Siemens AG and Zambon Group SpA. Investors can learn more about Sheffield
 Pharmaceuticals on its web site at www.sheffieldpharm.com .
 
     This press release contains certain forward-looking statements within the
 meaning of Section 27A of the Securities Act of 1933, as amended, and Section
 21E of the Securities Exchange Act of 1934, as amended, which are intended to
 be covered by the safe harbors created thereby.  Investors are cautioned that
 all forward-looking statements involve risks and uncertainty.  Although the
 Company believes that the assumptions underlying the forward-looking
 statements contained herein are reasonable, any of the assumptions could be
 inaccurate, and therefore, there can be no assurance that the forward-looking
 statements included in this press release will prove to be accurate.
 Important factors that could cause actual results to differ materially from
 the forward-looking statements include the Company's need to obtain
 substantial additional capital (through financings or otherwise) to fund its
 operations and the progress of development, government and regulatory
 approvals and licensing/commercialization of the Company's technologies.  In
 light of the significant uncertainties inherent in the forward-looking
 statements included herein, the inclusion of such information should not be
 regarded as a representation by the Company or any other person that the
 objectives and plans of the Company will be achieved.
 
 SOURCE  Sheffield Pharmaceuticals, Inc.