Aegerion Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of therapies for patients with debilitating rare diseases. Products Lomitapide The company’s first product, lomitapide, received marketing approval, under the brand name JUXTAPID (lomitapide) capsules (JUXTAPID), from the U.S. Food and Drug Administration (FDA) in 2012, as an adjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein apheresis where available, to reduce low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein cholesterol in adult patients with homozygous familial hypercholesterolemia (HoFH). The company launched JUXTAPID in the U.S. in January 2013. In July 2013, the company received marketing authorization for lomitapide in the European Union (EU), under the brand name LOJUXTA (lomitapide) hard capsules (LOJUXTA), as a treatment for HoFH in adults. Lomitapide is also approved for the treatment of HoFH in Mexico, Canada, and various other countries. The company sells lomitapide, on a named patient basis, in Brazil and in various other countries outside the U.S. where a mechanism exists based on the U.S. or the EU approval. The company intends to re-file its dossier for LOJUXTA in June 2015, which it expects would result in an assessment by the Gemeinsamer Bundesausschuss in late 2015. In Italy, the company is permitted to sell LOJUXTA on a named patient sales basis until the reimbursement and pricing approval process is completed in that country. Metreleptin The company acquired its second product, metreleptin, in January 2015, pursuant to an asset purchase agreement with Amylin Pharmaceuticals, LLC (Amylin) and AstraZeneca Pharmaceuticals LP, an affiliate of Amylin (together referred to as ‘AstraZeneca’). Metreleptin, a recombinant analog of human leptin, is marketed in the U.S. under the brand name MYALEPT (metreleptin) for injection (MYALEPT). MYALEPT received marketing approval from the FDA in February 2014 as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Under the terms of the asset purchase agreement, the company acquires the global rights to develop, manufacture and commercialize metreleptin, subject to an existing distributor license with Shionogi & Co., Ltd. covering Japan, South Korea and Taiwan. The company also assumed certain other assets and liabilities of AstraZeneca related to the metreleptin program. Distribution In the U.S., the company distributes each of its products through a single specialty pharmacy that distributes the product directly to patients, and under limited circumstances, to other purchasers. Agreements The company has a license agreement with The Trustees of the University of Pennsylvania (UPenn), pursuant to which the company obtained an exclusive, worldwide license from UPenn to certain know-how and a range of patent rights applicable to lomitapide. 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 company has filed an application seeking a five-year patent term extension for its U.S. patent covering the composition of matter of lomitapide, which was originally scheduled to expire in early 2015. 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 the company’s European Patent Office methods of use patent expires in 2025. The company’s metreleptin patent portfolio consists of three issued U.S. patents and issued patents in Europe, Canada, Israel, Australia, New Zealand, Mexico, China, Sou
aegerion pharmaceuticals inc
One Main Street
Cambridge, MA 02142
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