Alexion Pharmaceuticals is a leading American biotechnology company that is preparing to launch its first commercial product. Alexion was formed in 1992, listed on NASDAQ in 1996, and as of January, 2007 employs approximately 300 people at their Cheshire headquarters, Smithfield Rhode Island manufacturing plant, and Paris, France European headquarters. They expect to begin selling Soliris™(eculizumab) as a treatment for paroxysmal nocturnal hemoglobinuria, or PNH, during 2007 pending essential approvals from regulatory authorities.
Since their founding by scientists from Yale University, other research universities and the pharmaceutical industry, they have held a determined focus on translating cutting edge science into novel therapeutic products. Alexion’s strategy is to build on their strong scientific and product development base to develop novel antibody therapeutics targeting the treatment of patients with a wide array of severe disease states, including hematologic diseases, cancer, and autoimmune disorders. Alexion is dedicated to working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions.
Alexion’s clinical efforts have focused on treating disease by blocking formation of the terminal components of complement. Complement is an important and natural part of the human immune system that is comprised of a cascade of proteins, one protein leading to formation of the next. The earlier-formed components of the “complement cascade” are generally beneficial, but the later-formed, or terminal, components can have significant and deleterious effects.
Alexion’s lead product candidate, Soliris™(eculizumab), is a whole antibody, complement inhibitor that they have developed to treat PNH. PNH is a rare blood disorder characterized by the onset of severe hemolytic anemia, chronic fatigue and intermittent episodes of dark colored urine, known as hemoglobinuria. Significantly, PNH patients have a markedly increased risk of forming life-threatening blood clots, or thromboses, which are a leading cause of death in this disease. People with PNH produce red blood cells that lack a particular protein that otherwise protects red blood cells from destruction by terminal complement. Soliris™(eculizumab) is designed to block production of terminal complement, thereby preventing PNH red blood cell destruction. There currently is no drug specifically available for treatment of patients with PNH.
Alexion is planning to launch Soliris™(eculizumab) for sale in the United States and Europe during 2007, and in Japan and other key territories shortly thereafter, pending essential approvals from regulatory authorities in each territory. They are implementing infrastructure and strategies to support a world-class launch. In November 2005, they announced the formation of a wholly-owned subsidiary, Alexion Europe SAS, which will serve as the company’s initial European headquarters to manage all late stage development, regulatory and commercial operations throughout Europe.
Alexion is actively engaged in discovering and developing a pipeline of additional antibody therapeutics targeting the treatment of patients with severe unmet medical needs. Also, they are investigating the use of eculizumab in indications other than PNH in preclinical studies.
Leonard Bell, M.D. is the principal founder of Alexion, and has been a director of Alexion since February 1992 and the Company’s President and Chief Executive Officer, Secretary and Treasurer from January 1992.
For more information about Alexion, please visit their website.
