Advanced Life Sciences is moving expeditiously to develop a protocol for an additional Phase 3 trial that is designed to satisfy the FDA's request for additional efficacy information. The Company intends to meet with and work closely with the Agency to design and establish a protocol under a Special Protocol Assessment. The company anticipates that initiation of the additional Phase 3 program could take place in the first half of 2010. Advanced Life Sciences is working collaboratively on these clinical plans with Wyeth, its development and commercialization partner in the Asia Pacific region.
"Advanced Life Sciences appreciates the FDA's response to the Restanza NDA and is committed to complying with the Agency's requirements to conduct a clinical program that could lead to approval in CAP," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. "We are, however, disappointed that the timing of the new draft CAP guidance issuance had an unfortunate impact on the outcome of our NDA. Looking ahead, we intend to design a study that complies with the new draft CAP guidance and we will work with the Agency to determine the optimal pathway to registration."
Dr. Flavin continued, "We remain encouraged by the supportive comments made by AIDAC committee members in June relative to their positive view of the safety profile of Restanza, the therapeutic need for more effective treatments for CAP and their interest in seeing the Company pursue further development. We continue to receive strong support from our commercial partner Wyeth and intend to work in close collaboration with them as we implement our clinical program. We
|SOURCE Advanced Life Sciences Holdings, Inc.|
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