Aegerion Pharmaceuticals, Inc., a biopharmaceutical company, is engaged in the development and commercialization of therapies for patients with debilitating rare diseases. Products The company’s first product, Lomitapide, is a small molecule microsomal triglyceride transfer protein (MTP) inhibitor (MTP-I). MTP exists in both the liver and intestines where it plays a role in the formation of cholesterol. Lomitapide received marketing approval, under the brand name JUXTAPID (lomitapide) capsules (JUXTAPID), from the U.S. Food and Drug Administration (FDA), as an adjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH). It has also launched LOJUXTA in the United Kingdom and Germany. The company has completed a Phase 1 study of the pharmacokinetic and pharmacodynamic properties of lomitapide in Japanese HoFH patients. The company launched JUXTAPID in the U.S. in January 2013. In July, 2013, it received marketing authorization for lomitapide in the European Union (EU), under the brand name LOJUXTA (lomitapide) hard capsules (LOJUXTA), as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without LDL apheresis as a treatment for HoFH in adults. Lomitapide is also approved for the treatment of HoFH in Norway, Iceland, Mexico, and Canada. The company sells lomitapide, on a named patient basis, in Brazil and in various other countries outside the U.S. and the EU where such sales are authorized based on the U.S. or the EU approval. Distribution In the U.S., the company distributes JUXTAPID through a specialty pharmacy that distributes JUXTAPID directly to patients, and under limited circumstances, to other purchasers. Intellectual Property The company’s lomitapide patent portfolio consists of five issued U.S. patents and issued patents in Europe, Canada, Israel, Australia, New Zealand and Japan and pending applications in the U.S., Australia, Japan, Canada, India and South Korea, all of which have been licensed to the company in a specific field. The U.S. patent covering the composition of matter of lomitapide is scheduled to expire in 2015, and it has filed an application for patent term extension for this patent. The non-U.S. patents directed to the composition of matter of lomitapide issued in Canada, Israel, Japan, and certain EU countries are scheduled to expire in 2016. The company’s two method of use patents in the U.S., covering certain dosing regimens for lomitapide, expire in 2027 and 2025, respectively, and its European Patent Office methods of use patent expires in 2025. The company has a license agreement with The Trustees of the University of Pennsylvania, (UPenn) pursuant to which it obtained a worldwide license from UPenn to certain know-how and a range of patent rights applicable to lomitapide. Aegerion, JUXTAPID, and LOJUXTA are trademarks of the company. Regulatory Matters The company’s drugs must be approved by the FDA through the new drug application process before they might be legally marketed in the U.S., and must be approved by foreign regulatory authorities through various procedures before they could be marketed in the applicable country. The company’s international operations are subject to compliance with the Foreign Corrupt Practices Act, which prohibits corporations and individuals from paying, offering to pay, or authorizing the payment of anything of value to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity. History Aegerion Pharmaceuticals, Inc. was founded in 2005. The company was incorporated in 2005 under the laws of the state of Delaware.
aegerion pharmaceuticals inc
101 Main Street
Cambridge, MA 02142
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