Discovery Labs Receives Complete Response From FDA for Surfaxin(r) for Prevention of RDS
Conference Call Today At 9:00 AM
WARRINGTON, Pa., April 20, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (NasdaqGM:DSCO - News) today announced that, on April 17, 2009, it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. In its letter, the FDA focuses primarily on certain aspects of a Surfaxin biological activity test (BAT, a quality control stability and release test) that must be addressed before the Surfaxin application can be approved. Discovery Labs will host a conference call today at 9:00 AM. The call-in number for the conference call is 866-332-5218.
Discovery Labs believes that it has already submitted data necessary to respond to the questions raised by the FDA in the Complete Response letter and that its New Drug Application (NDA) is sufficient to gain marketing approval of Surfaxin. At this time, there are no questions regarding Discovery Labs' Phase 3 clinical trials, no comments regarding drug substance impurities, and no issues related to the manufacturing process for Surfaxin. Discovery Labs plans to seek an end of review meeting with the FDA to be scheduled as soon as possible. If the meeting is successful, Discovery Labs anticipates that Surfaxin may be approved in 2009.
In its Complete Response letter, the FDA focused on whether the BAT can adequately distinguish change in Surfaxin drug product over time and whether Discovery Labs has adequately validated the BAT and determined its final acceptance criteria. Validation of the BAT would confirm the comparability of Surfaxin drug product used in the clinical trials to the commercial Surfaxin drug product. Discovery Labs believes that data already submitted to the FDA support the comparability of Surfaxin clinical drug product to commercial Surfaxin drug product and demonstrate that the BAT can adequately distinguish change in Surfaxin over time and is an appropriate test for monitoring Surfaxin biological activity throughout its shelf-life.
The BAT is only one of numerous methods that Discovery Labs employs in an extensive quality surveillance program to assess product quality and stability of Surfaxin. These highly sophisticated tests monitor the quality of Surfaxin at release and through its shelf-life and represent very sensitive methods for detecting changes in product quality and identifying defective product.
In the Complete Response letter, the FDA also indicated that Discovery Labs needs to tighten one drug product specification, which can be readily implemented. The Complete Response letter also contained routine requests to update safety and other information in the NDA as well as information requests about certain regulatory matters. In addition, the FDA has approved the trade name Surfaxin.
Discovery Labs is analyzing all aspects of its business with an immediate intention to conserve cash. Although there can be no assurances, Discovery Labs is also exploring strategic alternatives, including, but not limited to, potential additional financings, as well as potential business alliances, commercial and development partnerships and other similar opportunities.
Conference Call Details
Discovery Labs will hold a conference call today at 9:00 AM EDT 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 through a live broadcast on the Internet at investor.shareholder.com and discoverylabs.com. The replay number to hear the conference call is 800-642-1687 or 706-645-9291. The passcode is 95842655. |
