Added DSCO to folio @ 5.9 - looking for rebound from the big dive in light of what they've heard from FDA (Stefaan on the ATC site thinks this should work!)
Discovery Labs Provides Update on FDA Pre-Approval Inspection Activities Pertaining to Surfaxin NDA Status
Tuesday February 1, 7:00 am ET
Conference Call Today at 8:45 AM EST
WARRINGTON, Pa., Feb. 1, 2005 (PRIMEZONE) -- Discovery Laboratories, Inc. (NasdaqNM:DSCO - News) is providing an update regarding key pre-approval inspection activities conducted by the U.S. Food and Drug Administration (FDA) in connection with the review of Discovery's New Drug Application (NDA) for Surfaxin(r) for the prevention of Respiratory Distress Syndrome in premature infants. The reporting of these inspection activities and the review of the Surfaxin NDA are the subject of a PDUFA letter that the Company anticipates receiving from the FDA on or about February 13, 2005.
The FDA has conducted pre-approval inspections of the NDA's major components, which include preclinical, clinical, chemistry, and manufacturing. To date, the results of the FDA's pre-approval inspections of Discovery's clinical data and clinical study sites have been extremely favorable. The Company believes that the clinical data is sufficient for approval and does not anticipate the need for additional trials to support approval.
With respect to manufacturing, the FDA recently issued a Form 483 to Laureate Pharma, Inc. (Laureate), Discovery's contract manufacturer of Surfaxin, citing inspection observations relating to compliance with current Good Manufacturing Practices (cGMPs) and other processes to be used for commercial production of the product. In response, Laureate and Discovery submitted a cGMP Action Plan on January 31, 2005 outlining measures intended to address the FDA's observations. The corrective actions outlined in the Action Plan are anticipated to be completed by July 2005. The commercial launch of Surfaxin, if approved, is now anticipated to occur in the fourth quarter of 2005.
The general theme of the inspection observations relates to basic quality controls, process assurances and documentation requirements that support the commercial production process. The Company believes that the Form 483 inspection observations are highly correctable in a reasonable period of time and do not relate to any clinical material produced to date. Based on the Form 483 issued to Laureate, Discovery now anticipates receiving a PDUFA letter constituting a Class 2 response, which will allow the FDA up to six months to review Discovery's NDA response and conduct a reinspection of Laureate's Totowa facility.
The FDA's Form 483 observations should be considered in light of the following:
-- The raw materials contained in Surfaxin are purchased from third
parties. These vendors have been inspected by the FDA with no
significant observations noted to date.
-- Discovery employs its own manufacturing equipment with its
proprietary process on the premises of Laureate in Totowa, New
Jersey. There are no fundamental flaws with the general
manufacturing process of Surfaxin.
-- There are no safety issues with the Surfaxin material that has
been manufactured and shipped from Laureate to Discovery's
clinical trial sites for use in its ongoing trials.
Discovery and Laureate have formed an Executive Steering Committee, consisting of Discovery's Chief Operating Officer, Laureate's President, and the Chairman of Laureate's Board of Directors, to oversee the correction of these observations in the shortest possible time.
Discovery's on-going clinical programs in Acute Respiratory Distress Syndrome in adults, Bronchopulmonary Dysplasia in premature infants, and aerosolized surfactant administered through nasal continuous positive airway pressure (nCPAP) for neonatal respiratory failures in premature infants are not affected and remain on track. If the inspection observations noted in the Form 483 issued to Laureate are not resolved in the time period stated above, a delay could occur in these programs.
Discovery will hold a conference call today at 8:45 AM EST. The call in number is 800-665-0669. This audio webcast will be available to shareholders and interested parties through a live broadcast on the Internet at irconnect.com and discoverylabs.com. It is recommended that participants log onto one of these sites at least 15 minutes prior to the call. The Internet broadcast will be available for up to 30 days after the call at both website addresses. |
