Discovery Laboratories Receives FDA Agreement On Pivotal Phase 3 IRDS Trial Design

Apr 04, 2001, 01:00 ET from Discovery Laboratories, Inc.

    DOYLESTOWN, Pa., April 4 /PRNewswire/ --
 Discovery Laboratories, Inc. (Nasdaq: DSCO) today announced plans to move
 forward with its pivotal Phase 3 multinational clinical trial evaluating
 Surfaxin(R) for the treatment of idiopathic respiratory distress syndrome
 (IRDS) in premature infants.
     The Phase 3 trial will evaluate Discovery's humanized Surfaxin(R) against
 currently available surfactant therapy in an active comparator trial where all
 babies receive surfactant prophylactically to assess safety and efficacy.
 This landmark trial contains endpoints designed to demonstrate the superiority
 of Surfaxin(R) over available therapy.  The Phase 3 trial will enroll
 approximately 1,500 patients and potentially take place in North and South
 America as well as Europe.  This trial is intended, if successful, to provide
 the basis for new drug applications with the FDA and worldwide regulatory
 authorities.
     "We are looking forward to getting this study underway as soon as
 possible," commented Robert J. Capetola, President and CEO of Discovery
 Laboratories.  "Our positive interactions with the FDA have resulted in the
 development of a protocol design that gives all patients access to drugs
 currently used in the U.S., while maintaining the rigorous standards necessary
 for evaluation by regulatory agencies worldwide.  We have previously
 established proof of principle with Surfaxin(R) in IRDS through a 47 patient
 Phase 2 trial.  We believe that Surfaxin(R) will be successful in this new
 study design.  We anticipate that our current resources are adequate to
 complete our clinical plans.  We expect to complete enrollment of this trial
 during the first half of 2002."
     Each year approximately 2 million babies worldwide are born premature with
 IRDS.  Of these, it is estimated that only approximately 200,000 have access
 to surfactant therapy.  The mortality rate for untreated infants ranges from
 40-70%.  The limited worldwide access to surfactants is due in part to the
 high cost of existing products and limitations in producing quantities at this
 scale from animal source materials.
     Surfaxin(R) is a humanized, peptide-containing surfactant that has
 demonstrated significant ability to lower surface tension at the air water
 interface (alveolar surface) in the lungs.  Additionally, compared to animal
 derived surfactants, Surfaxin(R) has the potential to be longer-acting, can be
 manufactured on a more consistent basis to meet worldwide demand, and does not
 have the possibility to transmit animal-borne infections or prion-related
 diseases.
     Discovery is a Pennsylvania-based bio-pharmaceutical company with
 approximately 36 full-time employees whose mission is to develop and
 commercialize medically novel therapeutics for critical care.  Presently,
 Discovery has two other clinical trials of Surfaxin(R) underway in the United
 States.  Surfaxin(R) is the subject of a pivotal Phase 3 clinical trial in
 meconium aspiration syndrome (MAS) in full term newborns for which no approved
 drug treatment presently exists.  In addition, the Company is involved in a
 Phase 2 clinical trial in acute respiratory distress syndrome (ARDS) in adults
 and is developing a second product, SuperVent(TM), to treat cystic fibrosis.
 The Company has been awarded an Orphan Products Development Grant for MAS and
 has received Fast Track designation for Surfaxin(R) from the FDA for MAS and
 ARDS.  The Company has previously been granted Orphan Drug Status for
 Surfaxin(R) from the FDA for MAS, RDS and ARDS.  Surfaxin(R) was invented and
 initially developed at The Scripps Research Institute.  More information about
 Discovery is available on the company's web site at:
 http://www.discoverylabs.com.
 
     To the extent that statements in this press release are not strictly
 historical, including statements as to the Company's business strategy,
 outlook, objectives, plans intentions, goals, future financial conditions,
 future collaboration agreements, the success of the Company's product
 development, or otherwise as to future events, such statements are
 forward-looking, and are made pursuant to the safe harbor provisions of the
 Private Securities Litigation Reform Act of 1995.  The forward-looking
 statements contained in this release are subject to certain risks and
 uncertainties that could cause actual results to differ materially from the
 statements made.  Among the factors which could affect the Company's actual
 results and could cause results to differ from those contained in the
 forward-looking statements contained herein are the risk that financial
 conditions may change, the risk that the Company will not be able to raise
 additional capital or enter into additional collaboration agreements, risks
 relating to the progress of the Company's research and development and the
 development of competing therapies and/or technologies by other companies.
 Those associated risks and others are further described in the Company's
 periodic filings with the Securities and Exchange Commission including the
 most recent reports on Form 10-KSB, 8-K and 10-QSB, and amendments thereto.
 
 

SOURCE Discovery Laboratories, Inc.
    DOYLESTOWN, Pa., April 4 /PRNewswire/ --
 Discovery Laboratories, Inc. (Nasdaq: DSCO) today announced plans to move
 forward with its pivotal Phase 3 multinational clinical trial evaluating
 Surfaxin(R) for the treatment of idiopathic respiratory distress syndrome
 (IRDS) in premature infants.
     The Phase 3 trial will evaluate Discovery's humanized Surfaxin(R) against
 currently available surfactant therapy in an active comparator trial where all
 babies receive surfactant prophylactically to assess safety and efficacy.
 This landmark trial contains endpoints designed to demonstrate the superiority
 of Surfaxin(R) over available therapy.  The Phase 3 trial will enroll
 approximately 1,500 patients and potentially take place in North and South
 America as well as Europe.  This trial is intended, if successful, to provide
 the basis for new drug applications with the FDA and worldwide regulatory
 authorities.
     "We are looking forward to getting this study underway as soon as
 possible," commented Robert J. Capetola, President and CEO of Discovery
 Laboratories.  "Our positive interactions with the FDA have resulted in the
 development of a protocol design that gives all patients access to drugs
 currently used in the U.S., while maintaining the rigorous standards necessary
 for evaluation by regulatory agencies worldwide.  We have previously
 established proof of principle with Surfaxin(R) in IRDS through a 47 patient
 Phase 2 trial.  We believe that Surfaxin(R) will be successful in this new
 study design.  We anticipate that our current resources are adequate to
 complete our clinical plans.  We expect to complete enrollment of this trial
 during the first half of 2002."
     Each year approximately 2 million babies worldwide are born premature with
 IRDS.  Of these, it is estimated that only approximately 200,000 have access
 to surfactant therapy.  The mortality rate for untreated infants ranges from
 40-70%.  The limited worldwide access to surfactants is due in part to the
 high cost of existing products and limitations in producing quantities at this
 scale from animal source materials.
     Surfaxin(R) is a humanized, peptide-containing surfactant that has
 demonstrated significant ability to lower surface tension at the air water
 interface (alveolar surface) in the lungs.  Additionally, compared to animal
 derived surfactants, Surfaxin(R) has the potential to be longer-acting, can be
 manufactured on a more consistent basis to meet worldwide demand, and does not
 have the possibility to transmit animal-borne infections or prion-related
 diseases.
     Discovery is a Pennsylvania-based bio-pharmaceutical company with
 approximately 36 full-time employees whose mission is to develop and
 commercialize medically novel therapeutics for critical care.  Presently,
 Discovery has two other clinical trials of Surfaxin(R) underway in the United
 States.  Surfaxin(R) is the subject of a pivotal Phase 3 clinical trial in
 meconium aspiration syndrome (MAS) in full term newborns for which no approved
 drug treatment presently exists.  In addition, the Company is involved in a
 Phase 2 clinical trial in acute respiratory distress syndrome (ARDS) in adults
 and is developing a second product, SuperVent(TM), to treat cystic fibrosis.
 The Company has been awarded an Orphan Products Development Grant for MAS and
 has received Fast Track designation for Surfaxin(R) from the FDA for MAS and
 ARDS.  The Company has previously been granted Orphan Drug Status for
 Surfaxin(R) from the FDA for MAS, RDS and ARDS.  Surfaxin(R) was invented and
 initially developed at The Scripps Research Institute.  More information about
 Discovery is available on the company's web site at:
 http://www.discoverylabs.com.
 
     To the extent that statements in this press release are not strictly
 historical, including statements as to the Company's business strategy,
 outlook, objectives, plans intentions, goals, future financial conditions,
 future collaboration agreements, the success of the Company's product
 development, or otherwise as to future events, such statements are
 forward-looking, and are made pursuant to the safe harbor provisions of the
 Private Securities Litigation Reform Act of 1995.  The forward-looking
 statements contained in this release are subject to certain risks and
 uncertainties that could cause actual results to differ materially from the
 statements made.  Among the factors which could affect the Company's actual
 results and could cause results to differ from those contained in the
 forward-looking statements contained herein are the risk that financial
 conditions may change, the risk that the Company will not be able to raise
 additional capital or enter into additional collaboration agreements, risks
 relating to the progress of the Company's research and development and the
 development of competing therapies and/or technologies by other companies.
 Those associated risks and others are further described in the Company's
 periodic filings with the Securities and Exchange Commission including the
 most recent reports on Form 10-KSB, 8-K and 10-QSB, and amendments thereto.
 
 SOURCE  Discovery Laboratories, Inc.