>>Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval
Monday January 22, 7:00 am ET
Conference Call Scheduled for Today At 11:00 AM EST
WARRINGTON, Pa., Jan. 22, 2007 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (NASDAQ:DSCO - News) announced today that it has received guidance from the U.S. Food and Drug Administration (FDA) in a recent meeting regarding the key remaining steps necessary for potential approval of Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The guidance provides the clarity and the defined pathway that Discovery believes is necessary to address key remaining issues identified in the April 2006 FDA Approvable Letter. Discovery anticipates filing its formal response to the Approvable Letter in September or October 2007, followed by a six-month review cycle by the FDA for potential approval of its New Drug Application (NDA) for Surfaxin.
The guidance was based on a face-to-face meeting with the FDA on December 21, 2006 as well as the FDA's review of the meeting briefing package submitted by Discovery on September 28, 2006.
* The defined pathway to potential Surfaxin approval does not
include a requirement for additional clinical trials.
* The April 2006 Approvable Letter primarily focused on the
Chemistry, Manufacturing and Controls (CMC) section of the
Surfaxin NDA and requested additional information predominantly
involving drug product specifications and related controls.
With the clarity gained at the FDA meeting, Discovery expects
to provide all of the necessary additional information in its
formal response to the Approvable Letter.
* Discovery provided information to the FDA regarding its
comprehensive investigation and remediation of the April 2006
Surfaxin process validation stability failure including the
identification of a most probable root cause. The comprehensive
investigation focused on analysis of manufacturing processes;
analytical methods and method validation; and active
pharmaceutical ingredient suppliers.
Consistent with Discovery's proposal included in the FDA meeting
briefing package, Discovery is planning to initiate the manufacture
of new Surfaxin process validation batches this week and will submit
six months of related stability data in its forthcoming formal
response to the Approvable Letter. Additionally, the FDA indicated
that Surfaxin shelf-life will be determined based upon comparative
stability data from historical Surfaxin batches, including previously
manufactured clinical, technology transfer, and investigational
batches, as well as the new process validation batches.
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Robert J. Capetola, Ph.D., President and Chief Executive Officer of Discovery, commented, ``The encouraging outcome of this important FDA meeting is a reflection of the leadership and efforts of our team of regulatory, manufacturing and quality executives. This executive team is also responsible for improving and enhancing the manufacturing operations that we acquired from our then contract manufacturer. With the clarity gained from the FDA meeting, the top priorities now are completing the necessary work to submit our response to the FDA for Surfaxin approval, and advancing Aerosurf(tm), our aerosolized surfactant therapy, into Phase 2 clinical trials.''
Conference Call Details
Discovery will hold a conference call today at 11:00 AM EST to further discuss the foregoing. The call in number is 866-332-5218. The international call in number is 706-679-3237. This audio webcast will be available to shareholders and interested parties through a live broadcast on the Internet at audioevent.mshow.com and discoverylabs.com. The replay number to hear the conference call is 800-642-1687 or 706-645-9291. The passcode is 6538198.<<
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Cheers, Tuck |
