New Drug Applications

Surfaxin

lucinactant

Treatment for Respiratory Distress Syndrome

Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters

Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters
Files Briefing Package and Requests Meeting With FDA to Gain Clarity On Key Requirements Leading to Surfaxin Approval

WARRINGTON, Pa., September 28, 2006 -- Discovery Laboratories, Inc. today has formally filed a briefing package and requested a meeting with the FDA to gain the Agency's agreement on the appropriate path towards Surfaxin (lucinactant) approval for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The package covers certain key Chemistry, Manufacturing and Controls (CMC) matters contained in the April 2006 Surfaxin Approvable Letter received from the FDA, as well as detailing Discovery's comprehensive investigation and remediation of the process validation failure. Discovery anticipates that the meeting will occur in the fourth quarter of 2006.

Importantly, Discovery's investigation into the April 2006 Surfaxin process validation stability failure has determined a most probable root cause. Remediation activities have been implemented that are consistent with the manufacturing procedures that produced the Surfaxin lots used in Discovery's highly successful Phase 3 clinical studies, which demonstrated that Surfaxin was significantly more effective in the prevention of RDS and also improved survival versus comparator surfactants. Discovery remains on-track to commence the manufacture of new process validation lots in the fourth quarter of 2006.

The Approvable Letter contains CMC issues that predominantly relate to active ingredient and drug product specifications and related controls. Notably, the Approvable Letter did not indicate the need for additional clinical trials. To address the process validation stability failure Discovery conducted a comprehensive investigation focused on analysis of manufacturing processes; equipment and process validation; manufacturing components; drug substances; review and assessment of out-of-specification and deviation reports; analytical methods and method validation; and change control documentation. Discovery has been able, through the investigative process, to simultaneously address certain CMC issues.

Discovery has successfully manufactured numerous lots of Surfaxin that achieved a desired stability profile. In December 2005 Discovery acquired and took control of the Totowa, NJ manufacturing operations of Laureate Pharma, Inc. Concurrently, pharmaceutical executives with extensive manufacturing, regulatory, and quality assurance expertise joined Discovery's senior management team. The expertise of these executives coupled with the remediation outcomes is expected to enhance pharmaceutical development across Discovery's broad SRT product pipeline.

Per FDA guidance, the Agency should notify Discovery of the meeting date within 14 days of receipt of Discovery's request and briefing package, and such meetings should occur within 75 days of the written request. While significant progress in Discovery's manufacturing investigation and remediation has been made, the investigation is ongoing and when completed, Discovery intends to finalize a comprehensive investigation report and corrective action plan.

Source: Discovery Laboratories, Inc.

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