Original Source: FD (FAIR DISCLOSURE) WIRE
OPERATOR: Good day everyone and welcome to the Alexion Pharmaceutical's Fourth Quarter Conference Call. Today's call is being recorded. [OPERATOR INSTRUCTIONS]
At this time for opening remarks and introductions I would like to turn the call over to Dr. Leonard Bell, Chief Executive Officer, please go ahead sir.
LEONARD BELL, CEO, ALEXION PHARMACEUTICALS: Thank you very much. I would like to thank everyone for joining us this morning. Sunny day after yesterday's snowstorm in the northeast. This will review our corporate developments and financial results for our fourth quarter and fiscal year 2006 year-end results.
I am glad to be joined today by members of Alexion Senior Management including Mr. David Keiser, President and Chief Operating Officer, Dr. Stephen Squinto, Executive Vice President ahead of Research, Mr. Vikar Sinha, Senior Vice President and Chief Financial Officer and Mr. Thomas Dubin, Senior Vice President General Counsel. Mr. Dubin will an price you of our potential to make forward-looking statements. Tom?
THOMAS DUBIN, SVP, ALEXION PHARMACEUTICALS: Thank you. During this conference call we may make forward-looking statements including statements related to financial guidance for calendar year 2007 including with respect to projected operating cost including for research, development, precommercialization and commercialization activities. Characterization of clinical trial results, commercial plans and commercial potential of Soliris and status and timing of regulatory decisions with respect to marketing applications for Soliris.
Forward-looking statements are subject to factors that may cause results and plans to differ from those expected, including delayed evaluation by regulatory agencies, decision of regulatory authorities not to approve or materially limit marketing Soliris, delays in arranging satisfactory manufacturing capacity, delays in developing or adverse changes in commercial relationships, the risk that third parties won't agree to license any necessary intellectual property to us on reasonable terms and a variety of other risks set forth from time to time in our filings with the SEC including but not limited to the risk discussed in a report on Form 10-Q for the quarter ended December 30, 2006. We do not intend to update any of these forward-looking statements to reflect events or circumstances after this conference call except where duty arises under law.
Thank you much. Dr. Bell.
LEONARD BELL: Thank you very much. Our discussion will consist of three parts regarding this quarter. It's been a very busy and productive session. I will first lead a review over the clinical and regulatory developments and accomplishments over the quarter. Mr. Keiser will then lead a review and summarize our precommercialization activities for Soliris. Then Mr. Sinha will conclude with a review of our financial performance for the fourth quarter and fiscal year 2006.
During this quarter we have significantly advanced the development of Soliris for the PNH indication. Our advances have been on both the clinical and regulatory fronts.
In December clinical investigators presented results at the American Society of Hematology meetings from three important studies evaluating Soliris and PNH. First, preliminary top line results from the 52 week open label controlled Phase III Shepherd study, showed that in a heterogenous P&H population, Soliris was well tolerated and separately was shown to significantly improve hemolysis leading to significant improvements in anemia, fatigue and health related quality of life.
Second, following on the September New England Journal of Medicine Publication that out lined the overall hemolysis, anemia and quality of life improvements a further analysis from Triumph presented at ASH also demonstrated that Soliris significantly improved hemolysis leading to significant improvement in anemia irrespective of the baseline transfusion requirements.
And third, in the Phase III extension trial E 05001 the assessment of a prospectively defined of secondary efficacy outcome, [thrombosis], the major cause of death in the PNH patient population show that Soliris significantly improved hemolysis leading to a marked and significant reduction in the risk of thrombosis in treated PNH patients. Whether in overflow scientific sessions with lead PNH investigators, state of the art educational sessions by international leaders for the broad international clinical community or in CME symposia, the ASH meetings were an exceptional scientific and precommercial milestone for Alexion.
Throughout the meetings the International Clinical Hematology and Oncology Communities showed their appreciation and excitement with regard to the potential break through that Soliris may bring to patients suffering from PNH. The explorer clinical program continues to enroll well. The study will help us to better understand clinical characteristics and frequency of PNH in patient with bone marrow [filaria syndrome]. We anticipate that explorer will continue to enroll throughout the year and will also commence enrollment in Europe later this year.
Indeed as we have become more integrated into the hematology and oncology clinical communities over the past few months clinicians have increasingly suggested that implementation of an explorer life program in the setting thrombosis may provide valuable information to the clinical community about the frequency and clinical characteristics of PNH in patients with unexplained arterial or venus blood clots. We expect to develop and implement such a clinical program later this year. I would now like to turn to Alexion's commitment to provide patients with PNH access to Soliris. Currently this commitment is on a preapproval basis with investigational drug Eculizumab. And we have active programs available for patients in the United States and in certain European countries.
In the U.S., the FDA has authorized a treatment protocol which is an early access program specifically designated for the preapproval treatment of patients with serious and life threatening diseases. We in the clinical community were extremely heartened by this decision by the FDA , as it …