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FDA Approves Aegerion Pharmaceuticals' JUXTAPID(TM) (lomitapide) Capsules For Homozygous Familial Hypercholesterolemia (HoFH)

Stocks in this article: AEGR

Gastrointestinal adverse reactions are common and may lead to treatment discontinuation. To reduce the risk of gastrointestinal adverse reactions, patients should adhere to a low-fat diet supplying less than 20% of energy from fat and the dosage of JUXTAPID should be increased gradually.

Combination with CYP3A4 inhibitors increases exposure to lomitapide. Strong and moderate CYP3A4 inhibitors should not be used with JUXTAPID. JUXTAPID dosage should not exceed 30 mg daily when used concomitantly with weak CYP3A4 inhibitors.

Due to risk of myopathy associated with simvastatin or lovastatin, doses of these agents should be limited when co-administered with JUXTAPID.

JUXTAPID increases the plasma concentrations of warfarin. Increases or decreases in the dose of JUXTAPID may lead to supra- or subtherapeutic anticoagulation, respectively. Patients taking warfarin should undergo regular monitoring of the INR, especially after any changes in JUXTAPID dosage.

Avoid use of JUXTAPID in patients with rare hereditary disorders of galactose intolerance.

Conference Call Details

The Aegerion management team will hold a conference call with the investment community Monday, December 24, 2012, at 8:30 a.m. EST. To listen to the live conference call, dial (866) 516-3002 (international callers dial (760) 298-5082). In addition, the conference call will be available through a live audio webcast in the "Investors" section of the Aegerion website, www.aegerion.com . The conference call will be accessible on the same website shortly after the conclusion of the call and archived there for up to 90 days.

About Aegerion Pharmaceuticals

Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating, often fatal, rare diseases. Our first approved product, JUXTAPID, is an oral once-daily capsule that offers a new treatment option to patients with homozygous familial hypercholesterolemia (HoFH) – a severe lipid disorder. For more information about the company, please visit www.aegerion.com .

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the availability of JUXTAPID and launch of JUXTAPID in the U.S., and the potential for JUXTAPID as a treatment for HoFH. 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 any delay or technical hurdle in completion of our validation work may delay availability of JUXTAPID for launch; the risk that JUXTAPID may not gain market acceptance; and the risk that restrictions imposed by regulatory authorities or the side effect profile may limit the commercial potential of JUXTAPID. 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: Investor Contact:
         Aegerion Pharmaceuticals, Inc.
         Michael Lawless, VP, IR
         (857) 242-5028
         mlawless@aegerion.com
         
         Media Contacts:
         Schwartz MSL Boston
         Andrew Law/Ben Navon
         781-684-6238 or 781-684-6548
         aegerion@mslgroup.com

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