CHESHIRE, Conn., July 6 -- Alexion Pharmaceuticals, Inc. announced today that it has appointed David L. Hallal as Vice President U.S. Commercial Operations. Reporting to David Keiser, President and Chief Operating Officer, Mr. Hallal will direct the expected launch of Soliris(TM) in the U.S., with responsibility for all U.S. commercial operations including sales, marketing, reimbursement and corporate account management, and customer relations.
"I am excited to have David join the Alexion senior management team and to lead the anticipated U.S. sales launch for Soliris in PNH," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "David has proven sales leadership and pharmaceutical product launch experience with five different biotech products, including first-in-class drugs, as well as hematology/oncology blockbuster products. David is a proven and tested sales and marketing leader with whom I look forward to collaborating as we move Soliris toward the U.S. marketplace."
Mr. Hallal, 40, has more than 17 years of commercial experience in the pharmaceutical industry. He joins Alexion from OSI Eyetech where, since 2004, he was Vice President of Sales. There he led the U.S. launch of the first-in-class anti-VEGF therapy, Macugen for age-related macular degeneration. Based on sales, Macugen became the most successful product launch in ophthalmology. Prior, Mr. Hallal was Senior Director of Sales for Biogen Idec's Immunology Sales Team, where he built a sales organization dedicated to the launch of the first-in-class biologic Amevive for psoriasis.
For more than ten years starting in 1992, Mr. Hallal held various leadership positions at Amgen, focusing on the blockbuster brands Epogen, Neupogen, Neulasta and Aranesp in the hematology and oncology marketplace. More specifically from 1999 to 2002, he served as the Southeast Oncology Sales Director and then helped Amgen build its first dedicated hospital sales team. During this time, Mr. Hallal played an integral role in pre-launch planning and the launch of Aranesp and Neulasta. From 1998 to 1999, Mr. Hallal served as Amgen's Director of Oncology National Accounts, where he played a significant role in developing key long-term partnerships with the nation's largest oncology practice management groups and physician group purchasing organizations. From 1992 to 1998, Mr. Hallal served in roles of escalating responsibility for the promotion of Epogen and Neupogen, including National Account Manager where he was responsible for forging relationships with many of the largest managed care organizations in the U.S. He holds a B.A. in psychology from the University of New Hampshire.
"David has demonstrated extensive operational and strategic capabilities in all areas of commercial launches for a variety of novel biopharmaceuticals in the U.S.," said David Keiser, President and Chief Operating Officer of Alexion. "His skills will be a tremendous asset to Alexion and we are now well positioned in the U.S., as well as in Europe, to take full advantage of the opportunity Soliris(TM) represents for PNH patients."
Alexion Pharmaceuticals is a biotechnology company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Alexion is engaged in the discovery and development of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic diseases, cancer, and autoimmune disorders. Alexion's lead product candidate, Soliris(TM) (eculizumab), is currently undergoing evaluation in several clinical development programs, including for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Under the Special Protocol Assessment (SPA) process, the FDA has agreed to the design of protocols for the two phase III trials of Soliris(TM) (eculizumab) in PNH patients that could, if successful, serve as the primary basis of review for approval of a licensing application for eculizumab in the PNH indication. In January, 2006, Alexion announced that the first of those two PNH trials, the TRIUMPH study, achieved its co-primary endpoints with statistical significance. In June, 2006, Alexion announced that interim results from the second of those two PNH trials, the SHEPHERD study, showed that eculizumab appeared to be safe and well tolerated and that all primary and secondary efficacy endpoints were achieved with statistical significance. Alexion is engaged in discovering and developing a pipeline of additional antibody therapeutics targeting severe unmet medical needs. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: http://www.alexionpharm.com.
This news release contains forward-looking statements, including statements related to clinical trial results, timing of announcement of clinical trial results, commercial potential of Alexion's drug candidates, the progression of Alexion's drug candidates towards commercial sales and timing for submission of, and decisions with respect to, marketing applications for Soliris(TM)(eculizumab). Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including delays in completion of ongoing clinical trials, delays in completion of analysis of clinical trial results, timing and evaluation by regulatory agencies of the results of these and other clinical trials, the results of pre-clinical or clinical studies (including termination or delay in clinical programs), the need for additional research and testing, decision of the FDA or other regulatory authorities not to approve (or to materially limit) marketing of Alexion's drug candidates, delays in arranging satisfactory manufacturing capability, inability to acquire funding on timely and satisfactory terms, delays in developing or adverse changes in commercial relationships, the possibility that results of earlier clinical trials are not predictive of safety and efficacy results in later clinical trials, 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 Alexion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion's Transition Report on Form 10-K/T for the five-month transition period ended December 31, 2005 and in our other filings with the Securities and Exchange Commission. Alexion does not intend to update any of these forward- looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.