The FDA has also requested an electron microscopy lung tissue analysis. We expect to initiate these preclinical studies for AEGR-733 and AEGR-427 (implitapide) in the first half of 2008. Although pulmonary phospholipidosis is not readily monitorable in the clinical setting, we also plan to monitor the effect of AEGR-733 and AEGR-427 (implitapide) on pulmonary function through pulmonary function testing as part of our planned Phase II hepatic imaging trials of AEGR-733 and AEGR-427 (implitapide) and the pivotal Phase III trial of AEGR-733 in patients with HoFH. In prior human clinical trials with AEGR-733 and AEGR-427 (implitapide) in which pulmonary function testing has been conducted, there has been no evidence of any complication of pulmonary function.

Phase II Clinical Trial to Evaluate the Safety and Efficacy of AEGR-733 +/- Lipitor (atorvastatin)

Also in June 2007, we voluntarily halted a Phase II clinical trial to evaluate the safety and efficacy of AEGR-733 +/- Lipitor (atorvastatin) in patients with hypercholesterolemia because of suspected microbial contamination, which we believe resulted in patients experiencing gastrointestinal adverse events at a rate, severity and rapidity of onset that was inconsistent with our prior clinical experience with this drug. After extensive testing and other investigation, we believe the cause of these adverse events was the introduction into our clinical supplies of the bacterium Bacillus cereus , or B. cereus , which is most often identified with food borne illness. We subsequently manufactured a new lot of active pharmaceutical ingredient, or API, and a new lot of clinical supplies utilizing a previously tested lot of API. A subsequent clinical trial of AEGR-733 conducted using this newly manufactured lot of clinical supplies did not result in a discontinuation rate consistent with that experienced in the halted AEGR-733 +/- Lipitor (atorvastatin) trial.

Although we halted this Phase II clinical trial, we believe the partial data collected from the trial demonstrates the potential for a significant additive effect of this compound when used in combination with Lipitor (atorvastatin). For example, after two weeks of treatment, which would not in our experience be sufficient time to achieve maximum effect for either drug, patients treated with AEGR-733 at doses ranging from 2.5 mg to 10 mg in combination with Lipitor (atorvastatin) 20 mg had a statistically significant decrease in LDL-C levels from baseline, achieving an average reduction of LDL-C that ranged from 52.3-73.2%. Using our newly manufactured and tested lot of clinical supplies, we expect to initiate a new Phase II clinical trial of AEGR-733 +/- Lipitor (atorvastatin) in patients with hypercholesterolemia in the fourth quarter of 2007.

Business Development

In April 2007, Proceedings of the National Academy of Sciences published the results of in vitro studies of AEGR-733 conducted by The University of Texas Southwestern Medical Center that we believe demonstrate the potential for MTP-Is to inhibit the extracellular secretion of the hepatitis C virus. During the summer of 2007, we replicated these in vitro studies in AEGR-427 (implitapide). In November 2007, we entered into an exclusive license agreement with The University of Texas System, on behalf of The University of Texas Southwestern Medical Center, to a patent application directed to treating hepatitis C using MTP-Is, small interfering ribonucleic acids, or RNAs, or antisense oligonucleotides directed against apolipoprotein B, or apoB. ApoB is the protein that carries certain forms of cholesterol and triglyceride particles in the bloodstream.

Risks Associated with Our Business

Our business is subject to numerous risks, as more fully described in the section entitled “Risk Factors” immediately following this prospectus summary, including the following:

 

•

We have a limited operating history, have incurred substantial net losses, and had a deficit accumulated during development stage of $23.6 million as of September 30, 2007.

 

•

We expect to continue to incur substantial losses for the foreseeable future, and we expect these losses to increase as we conduct larger scale trials for our product candidates.

 

•

Our product candidates are undergoing clinical trials, and failure is common and can occur at any stage of development.

 

•

The FDA has imposed a partial clinical hold with respect to clinical trials of longer than six months duration for our product candidates, and if we are unable to successfully complete the preclinical studies required by the FDA, or otherwise satisfy the FDA’s concerns related to pulmonary phospholipidosis, in particular with respect to broader patient populations beyond those patients with severe genetic disorders such as HoFH, we could be delayed in, or prevented from, obtaining regulatory approval of our product candidates.

 

•

Our product candidates may cause undesirable side effects, such as gastrointestinal adverse events or the accumulation of fat in the liver, or have other properties that could delay or prevent their regulatory approval or limit the commercial profile of any approved label.

 

•

Even if we succeed in obtaining regulatory approval for one or both of our product candidates, we may never generate sufficient revenue to achieve and sustain profitability.

 

•

Our ability to generate product revenue in the future will depend heavily on the successful development and commercialization of our product candidates, AEGR-733 and AEGR-427 (implitapide).

 

•

We can provide no assurance to you that our future clinical trials for AEGR-733 and AEGR-427 (implitapide) will achieve positive results.

 

•

We cannot be certain that the National Cholesterol Education Program will establish guidelines advising a target LDL-C goal of <70 mg/dL for all high-risk patients, and if these guidelines are not established, our competitive position, revenues and business prospects may be harmed.

Corporate Information

We were founded in 2005 as a Delaware corporation. Our principal executive offices are located at CenterPointe IV, 1140 Route 22 East, Suite 304, Bridgewater, New Jersey 08807, and our telephone number is (908) 707-2100. Our web site address is www.aegerion.com. The information on our web site is not part of this prospectus.

Aegerion is a registered trademark of Aegerion Pharmaceuticals, Inc. in the United States and a trademark in other countries. This prospectus also includes other trademarks of Aegerion Pharmaceuticals, Inc. and other persons.

Except where the context requires otherwise, in this prospectus “Company,” “Aegerion,” “we,” “us” and “our” refer to Aegerion Pharmaceuticals, Inc.