Discovery Labs (DSCO) Plans to Initiate AEROSURF Phase 2 in Late 2013
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On June 22, 2012, Discovery Labs (Nasdaq: DSCO), entered into a Research and Development Services Agreement effective as of June 22, 2012, with Battelle Memorial Institute. Battelle is the world’s largest nonprofit research and development organization, with over 20,000 employees at more than 100 locations globally, with a particular expertise in developing and integrating aerosol devices using innovative and advanced technologies.
Pursuant to the Agreement, Battelle will provide services in support of the Company’s ongoing development program for its proprietary Capillary Aerosol Generator (CAG), initially for AEROSURF for respiratory distress syndrome (RDS).
AEROSURF is a drug/device combination product that combines the Company’s KL4 surfactant with its CAG and novel AFECTAIR® ventilator circuit/patient interface connectors. The Company is developing AEROSURF for premature infants with or at risk for developing RDS. Premature infants with RDS are currently treated with animal-derived surfactants that can only be administered by endotracheal intubation supported with mechanical ventilation, both invasive procedures that may result in serious respiratory conditions and complications. As a consequence, neonatologists will often not treat infants who could benefit from surfactant therapy unless the potential benefits of surfactant therapy outweigh the risks associated with such invasive administration procedures. AEROSURF potentially will provide practitioners with the ability to deliver surfactant therapy using a less-invasive method.
Battelle will assist in the development of device components, which will be implemented in a series of phased programs focused on design, testing, and manufacturing of clinical-ready CAG devices for use in the Company’s planned AEROSURF phase 2 clinical trials, which the Company is planning to initiate in late 2013. The Company will retain the authority for all final decisions and all responsibility for the formulation, design, manufacture, assembly, packaging, marketing, distribution and sale of the Company’s products. The initial term of the Agreement is two years from the Effective Date (the “Term”) unless the Agreement is terminated early pursuant to its terms. Either party may terminate the Agreement upon 15 days written notice to the other party for any good-faith basis, provided, however, that Battelle does not have the right to terminate the Agreement until it has substantially completed the then-current phase of the project. In addition, Battelle has the right to terminate the Agreement upon 15 days’ written notice to the Company in the event that the Company is in material breach under the Agreement, and such breach is not cured within such 15-day period. The agreement contains provisions customary to a services agreement, including payment terms, warranties, intellectual property and confidentiality provisions. If fully-implemented through all proposed phases, the Agreement could involve an investment by the Company of approximately $4.6 million.
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Pursuant to the Agreement, Battelle will provide services in support of the Company’s ongoing development program for its proprietary Capillary Aerosol Generator (CAG), initially for AEROSURF for respiratory distress syndrome (RDS).
AEROSURF is a drug/device combination product that combines the Company’s KL4 surfactant with its CAG and novel AFECTAIR® ventilator circuit/patient interface connectors. The Company is developing AEROSURF for premature infants with or at risk for developing RDS. Premature infants with RDS are currently treated with animal-derived surfactants that can only be administered by endotracheal intubation supported with mechanical ventilation, both invasive procedures that may result in serious respiratory conditions and complications. As a consequence, neonatologists will often not treat infants who could benefit from surfactant therapy unless the potential benefits of surfactant therapy outweigh the risks associated with such invasive administration procedures. AEROSURF potentially will provide practitioners with the ability to deliver surfactant therapy using a less-invasive method.
Battelle will assist in the development of device components, which will be implemented in a series of phased programs focused on design, testing, and manufacturing of clinical-ready CAG devices for use in the Company’s planned AEROSURF phase 2 clinical trials, which the Company is planning to initiate in late 2013. The Company will retain the authority for all final decisions and all responsibility for the formulation, design, manufacture, assembly, packaging, marketing, distribution and sale of the Company’s products. The initial term of the Agreement is two years from the Effective Date (the “Term”) unless the Agreement is terminated early pursuant to its terms. Either party may terminate the Agreement upon 15 days written notice to the other party for any good-faith basis, provided, however, that Battelle does not have the right to terminate the Agreement until it has substantially completed the then-current phase of the project. In addition, Battelle has the right to terminate the Agreement upon 15 days’ written notice to the Company in the event that the Company is in material breach under the Agreement, and such breach is not cured within such 15-day period. The agreement contains provisions customary to a services agreement, including payment terms, warranties, intellectual property and confidentiality provisions. If fully-implemented through all proposed phases, the Agreement could involve an investment by the Company of approximately $4.6 million.
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