s a rare metabolic disorder characterized by severe and rapidly progressive neurologic damage and death in newborns. ALXN 1102/1103: ALXN 1102/1103 is a alternative pathway complement inhibitor with a mechanism of action from Soliris. ALXN 1102 is being investigated in a Phase I single dose, dose escalating safety and pharmacology study. ALXN 1103 is being dosed in the same Phase I trial as a subcutaneous or intravenous formulation. ALXN 1007: ALXN 1007 is a humanized antibody designed to target rare and severe inflammatory disorders and is a product of the company’s proprietary antibody discovery technologies. The company completed enrollment in both a Phase I single-dose, dose escalating safety and pharmacology study in healthy volunteers, as well as in a multi-dose, dose escalating safety and pharmacology study in healthy volunteers. Sales and Marketing The company has established a commercial organization to support sales of Soliris in the United States, in the major markets in European Union, Japan, the Asia Pacific countries, and other territories. License Agreements The company has a license agreement with the Medical Research Council (MRC) whereby MRC granted to it worldwide non-exclusive rights to certain patents related to the humanization and production of monoclonal antibodies. In 2013, the company entered into a license and collaboration agreement with Ensemble Therapeutics Corporation for the identification, development and commercialization of therapeutic candidates based on specific drug targets. In January 2014, the company entered into an agreement with Moderna Therapeutics, Inc. (Moderna) that provides the option to purchase drug products for clinical development and commercialization of Moderna's messenger RNA (mRNA) therapeutics to treat rare diseases. Patents and Proprietary Rights As of December 31, 2013, the company owned or in-licensed 95 U.S. patents, 126 foreign patents, 69 U.S. patent applications and 450 foreign patent applications. These patents and patent applications relate to C5 inhibitors, high throughput screening, vectors, cancer, recombinant antibodies, bone delivery conjugates, natriuretic peptides, human molybdenum cofactor deficiency, targeted complement inhibitors, and other technologies. December 31, 2013, the company owned or in-licensed 95 U.S. patents, 126 foreign patents, 69 U.S. patent applications and 450 foreign patent applications. With respect to Soliris, the company has an issued U.S. patent that would expire in 2021, taking into account patent term extension. The company also owns a corresponding issued European patent that covers Soliris and would expire in 2015, though in certain European countries where it filed for supplementary protection certificates. In Japan and other countries where the company owns patents covering Soliris the patents would expire between 2015 and 2020. Customers In the United States, the company’s customers are primarily specialty distributors and specialty pharmacies which supply physician office clinics, hospital outpatient clinics, infusion clinics, or home health care providers. It also sells Soliris to government agencies. Outside the United States, its customers are primarily distributors, pharmacies, hospitals, hospital buying groups, and other health care providers. Regulations Soliris is regulated by the FDA as a biologic. The company submitted its Marketing Authorization Application for Soliris for the treatment of PNH and aHUS to the European Medicines Agency using the centralized marketing authorization procedure. The company is subject to the United States Foreign Corrupt Practices Act (FCPA), the U.K. Bribery Act (U.K. Bribery Act), and other anti-corruption laws and regulations pertaining to its financial relationships with government officials. Significant Events Alexion Pharmaceuticals and Cincinnati Children's Hospital Medical Center have announced the establishment of a collaboration and fund for the advancement of research in rare disease. History Alexion Pharmaceuticals, Inc. was founded in 1992. The company was incorporated in 1992.
alexion pharmaceuticals inc
352 Knotter Drive
Cheshire, CT 06410
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