XBiotech announces outcome of EMA's Oral Explanation meeting
XBiotech announced that the European Medicines Agency rendered a negative "trend" vote after meeting with the Company to discuss the "Day 180 List of Outstanding Issues" related to the Company's marketing authorization application for its candidate antibody for the treatment of colorectal cancer. A negative trend vote means it is unlikely that a positive Committee for Medicinal Products for Human Use opinion related to the Company's MAA will be attained at the formal decision vote scheduled in May, and that additional steps would need to be taken to potentially gain marketing approval. At the Oral Explanation meeting, per EMA protocol, the Company gave a 20 minute presentation and had a Q&A session with CHMP members regarding the MAA for its candidate therapy to treat advanced colorectal cancer (data presented by the Company will be filed with the SEC in a Form 8-K and will be available on the SEC's website. The Oral Explanation format is intended to provide an opportunity for the Company to clarify data in support of marketing authorization. The key outstanding issues are related to clinical relevance of the therapy in the indication and quality assurance related matters. The meeting, however, focused on outstanding clinical relevance issues. John Simard, President & CEO of the Company, stated, "We are disappointed by the outcome of the meeting. We believe that the data speak in a clear and resounding voice to clinical relevance of a new antibody therapy in advanced colorectal cancer. We believe that findings from our Phase III study show that we have developed an important endpoint and methodology to evaluate anti-cancer therapy in advanced stage disease and that our monoclonal antibody represents a breakthrough treatment in patients with advanced colorectal cancer. The EMA marketing authorization application procedure enables the appeal of negative decisions from the oral explanation. We may seek access to this process at the appropriate time."