ent of delayed kidney transplant graft function (DGF) and is in Phase III development stage. The company is developing Soliris (eculizumab) for the treatment of antibody mediated rejection (AMR) presensitized renal transplant - living donor and is in Phase II development stage. It is developing Soliris (eculizumab) for the treatment of AMR presensitized renal transplant - deceased donor and is in Phase II development stage. The company is developing Soliris (eculizumab) for the treatment of AMR and is in Phase II development stage. cPMP (ALXN 1101) The company is developing cPMP (ALXN 1101) for the treatment of MoCD Type A and is in Phase II/III development stage. 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 is developing ALXN 1007 for the treatment of GI Graft versus Host Disease and Anti-phospholipid Syndrome and is in Phase II development stage. SBC-103 SBC-103, a recombinant form of natural human NAGLU is designed to replace the missing (or deficient) NAGLU enzyme. SBC-103 was granted orphan drug designation by the FDA in April 2013 and by the European Medicines Agency (EMA) in June 2013. It received Fast Track designation by the FDA in 2015. The company is developing SBC-103 for the treatement of Mucopolysaccharidoses IIIB and is in Phase I/II development stage. ALXN 1210 ALXN 1210 is a next-generation complement inhibitor in development for PNH and other indications. The company has two ongoing clinical studies of ALXN 1210 in patients with PNH. ALXN 5500 The company is developing ALXN 5500 in next generation complement inhibitor development area and is in Phase I development stage. Sales and Marketing The company has established a commercial organization to support sales of its products in the United States, Europe, Japan, the Asia Pacific countries, and other territories. Acquisitions In 2015, the company acquired Synageva BioPharma Corp., a publicly-held clinical-stage biotechnology company. Customers The company’s customers primarily include distributors, pharmacies, hospitals, hospital buying groups, and other health care providers. License and Collaboration Agreements The company has an agreement with X-Chem Pharmaceuticals (X-Chem) that allows it to identify novel drug candidates from X-Chem's proprietary drug discovery engine. The company has a license and collaboration agreement with Ensemble Therapeutics Corporation for the identification, development and commercialization of therapeutic candidates based on specific drug targets. Intellectual Property Rights Soliris Exclusivity With respect to Soliris, the company owns an issued U.S. patent that covers the eculizumab composition of matter and would expire in 2021, taking into account patent term extension. Soliris is also protected in the U.S. by regulatory data exclusivity until 2019 and by orphan drug exclusivity for treating aHUS until 2018. In Europe, the company has supplementary protection certificates that extend rights associated with a composition of matter patent until 2020 in certain countries. Soliris is also protected in Europe by orphan drug exclusivity until 2019 for PNH and until 2023 for aHUS. In addition to the foregoing patent and regulatory protections, the company owns pending patent applications that are directed to various aspects of using and making eculizumab and which may provide additional protection for Soliris. Strensiq Exclusivity With respect to Strensiq, the company owns an issued U.S. patent that covers the asfotase alfa composition of matter and would expire in 2026. The company is applying for an extension of the U.S. patent term. Strensiq is also protected in the U.S. by orphan drug exclusivity until 2022 and by regulatory data exclusivity until 2027. In Europe, the company owns two issued patents that cover the asfotase alfa composition of matter and would expire in 2025 and 2028. The company is applying for supplementary protection certificates in the European countries. Strensiq is also protected in
alexion pharmaceuticals inc
(ALXN:Consolidated Issue Listed on NASDAQ Global Select )
100 College Street
New Haven, CT 06510
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