10Q:
In March 2005, we announced that while the STELLAR 3 study missed its primary endpoint of superior overall survival, it had equivalent efficacy to paclitaxel in combination with carboplatin. XYOTAX had a reduction in certain side effects, including hair loss, muscle and joint pain, and cardiac symptoms. Complete research findings from this trial were presented at the American Society of Clinical Oncology, or ASCO, meeting in May 2005 and at the 11th World Conference on Lung Cancer in July 2005.
In May 2005, we announced that the STELLAR 2 and 4 clinical trials demonstrated comparable survival with significant reductions in certain serious side effects compared to the comparator arms, although both studies missed their primary endpoints of superior overall survival. We believe XYOTAX addresses an important medical need – an effective, better tolerated taxane with easier administration, and we will continue our ongoing dialogue with the FDA and regulatory authorities for the European Medicinal Evaluation Agency, or EMEA, regarding submission of an NDA in the U.S. and Marketing Authorization Application, or MAA, in the EU for XYOTAX based on the STELLAR trial results. If the FDA and EMEA agrees to a filing strategy using the current STELLAR trial results, we would target for submission of an NDA for XYOTAX in the first half of 2006, and depending on the duration of the review cycle, a U.S. XYOTAX approval targeted in 2007 with launch shortly thereafter. Approval in the EU would be targeted approximately 10 months following the submission of an MAA. If the FDA and EMEA does not agree to an acceptable filing strategy with the existing clinical trial results, then our regulatory filing would be delayed. Preliminary response from the FDA suggests that we may not be able to reach agreement on a filing strategy, in which case our regulatory filing and approval, if any, would be delayed. We will continue to explore whether such an agreement can be reached.
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