Staff Writer

With its eye on the $30 billion worldwide market for lipid-lowering drugs, Aegerion Pharmaceuticals Inc. filed to raise $86 million through an initial public offering.

If the Bridgewater, N.J.-based company is able to achieve its goal, it will be able to claim the second-largest biotech IPO so far this year, behind Chinese firm 3SBio Inc.'s $115.2 million offering.

The average listing price for the 10 biotechs to go public so far this year is just $40.7 million, although counting only the five Nasdaq-listed biotechs ups the average to $62.9 million.

Aegerion's price per share and number of shares to be offered have not yet been disclosed, but the company applied to list on the Nasdaq as "AEGR." Underwriters for the offering include Lehman Brothers, CIBC World Markets, Thomas Weisel Partners LLC and C.E. Unterberg Towbin.

To date, Aegerion's money has come primarily from a $22.5 million Series A financing completed in mid-2006. Advent International led the round, with Index Ventures, Alta Partners and MVM Life Science Partners also participating. Earlier this month, the company took a $10 million loan from Hercules Technology Growth Capital Inc. (See BioWorld Today, June 14, 2006.)

Aegerion executives were not available to comment, but the company's prospectus stated that proceeds from the IPO will be used to repay that loan. The rest of the money will fund clinical development of AEGR-733 and AEGR-427 (implitapide), both small-molecule microsomal triglyceride transfer protein (MTP) inhibitors for hyperlipidemia. Aegerion also may use a portion of the funds for general corporate purposes, including acquisitions of additional product candidates.

AEGR-733, licensed from the University of Pennsylvania, is a once-daily pill for patients with hyperlipidemia who are unable to meet their goals using other treatments. Statins such as Lipitor (atorvastatin, Pfizer Inc.), Crestor (rosuvastatin, AstraZeneca plc) and Zocor (simvastatin, Merck and Co. Inc.) can reduce low-density lipoprotein (LDL) cholesterol by about 25 percent to 55 percent, while cholesterol absorption inhibitors such as Zetia (ezetimibe, Schering Plough Corp.) lower it about 18 percent and combination drugs like Vytorin (simvastatin and ezetimibe) may achieve a 60 percent reduction. Yet Aegerion estimates about 8 million Americans still won't hit the recommended level of less than 70 mg/dL for patients at risk of cardiovascular disease, and 1.5 million U.S. patients are statin-intolerant.

In a Phase II trial, the combination of AEGR-733 and Zetia lowered LDL cholesterol 46.2 percent at 12 weeks, compared to 29.9 percent for AEGR-733 alone and 19.9 percent for Zetia alone. Aegerion plans to initiate a similar Phase II trial using Lipitor in the first half of the year.

AEGR-733 also may be able to address an orphan indication within the massive cholesterol market: a rare genetic disorder known as homozygous familial hypercholesterolemia (HoFH). The University of Pennsylvania School of Medicine conducted a six-patient Phase II study in which AEGR-733 as a monotherapy reduced LDL cholesterol 51 percent on average, compared to the 20 percent to 25 percent reduction that patient group usually achieved on high-dose statins. Aegerion plans to file for orphan drug status and begin a Phase III trial in the second half of the year.

AEGR-427, licensed from Bayer Healthcare AG, of Leverkusen, Germany, is a once-daily pill for hyperlipidemia that also may impact weight loss. Bayer conducted a Phase II trial in which the drug resulted in a dose-dependent LDL cholesterol reduction of up to 55.1 percent, but the high doses resulted in a high incidence of side effects. To address that issue, Aegerion plans to combine lower doses of the drug with other cholesterol-lowering drugs. A Phase II dose ranging trial at lower doses is slated to begin in the second half of 2007, along with a Phase I trial in patients on Lipitor, Crestor and Zocor.

Founded in 2005, Aegerion accumulated losses attributable to common stockholders of $9.3 million between inception and Dec. 31, 2006. During 2006, the company used $5.5 million of net cash to fund operating expenses, ending the year with $16.6 million in cash and equivalents.