FDA Advisory Committee Recommends Approval Of Lomitapide For Treatment Of Homozygous Familial Hypercholesterolemia (HoFH)
About Aegerion Pharmaceuticals, Inc.
Aegerion Pharmaceuticals, Inc.is an emerging biopharmaceutical company focused on the development and commercialization of novel, life-altering therapeutics to treat debilitating and often fatal rare diseases. The company's lead drug candidate, lomitapide, is in late-stage development for the treatment of Homozygous Familial Hypercholesterolemia (HoFH), a rare life-threatening disease characterized by severely elevated cholesterol levels.
Aegerion is motivated by its commitment to patients first, as well as its core values of integrity, innovation, responsibility to healthcare providers and development of employees, with a constant focus on scientific and clinical excellence. For more information, visit www.aegerion.com .
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the potential for regulatory approval and launch of lomitapide. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other factors: the risk that applicable regulatory authorities may ask for additional data, information or studies to be completed or provided prior to approval; the risk that the FDA may not follow the recommendations of EMDAC; the risk that applicable regulatory authorities may not agree with our validation plan or may require additional work related to the commercial manufacturing process to be completed prior to approval or may, in the course of the inspection of manufacturing facilities, identify issues to be resolved; the risks that the applicable regulatory authorities may not be satisfied with the safety profile of lomitapide; and the risk that we do not receive approval of lomitapide on a timely basis or at all. For additional disclosure regarding these and other risks we face, see the disclosure contained in our public filings with the U.S. Securities and Exchange Commission (available on the SEC's website at http://www.sec.gov), including the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.CONTACT: Aegerion Pharmaceuticals, Inc.
Michael Lawless, VP, IR
(857) 242-5028
mlawless@aegerion.com
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