Five months after pulling its proposed initial public offering due to unfavorable market conditions, Aegerion Pharmaceuticals Inc. is testing the IPO waters once again.
The Bridgewater, N.J.-based company filed last week to raise up to $86 million in an IPO. The price per share and number of shares to be offered have not yet been disclosed, but Aegerion applied to list on the Nasdaq under the symbol "AEGR." The new team of underwriters includes Piper Jaffray, Thomas Weisel Partners LLC, Lazard Capital Markets and Collins Stewart LLC.
Last March, Aegerion filed to raise up to $86 million in an IPO. The company later set terms for the deal at $12 to $14 per share for 5 million shares, the midrange of which would have generated $65 million. But Aegerion pulled the deal a few months later. (See BioWorld Today, March 22, 2007.)
This time around, the initial target of $86 million is the same, as is the intended use of proceeds. Aegerion plans to use funds from the offering to repay a $10 million loan from Hercules Technology Growth Capital Inc., which it borrowed in March to help pay for costs associated with the offering. Remaining funds will support clinical trials of AEGR-733 and AEGR-427 (implitapide), both of which are small-molecule microsomal triglyceride transfer protein (MTP) inhibitors for hyperlipidemia, as well as preclinical studies and general corporate purposes.
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. In a Phase II trial, AEGR-733 combined with Zetia (ezetimibe, Schering Plough Corp.) lowered low-density lipoprotein (LDL) cholesterol 46.2 percent at 12 weeks, compared to 29.9 percent for AEGR-733 alone and 19.9 percent for Zetia alone. Another Phase II trial showed that the drug used as a monotherapy reduced LDL cholesterol 51 percent on average in patients with homozygous familial hypercholesterolemia (HoFH), compared to the 20 percent to 25 percent reduction that patient group usually achieves on high-dose statins.
Aegerion plans to begin two additional Phase II trials with AEGR-733 by the end of the year, one in combination with Lipitor (atorvastatin, Pfizer Inc.) and one evaluating the effects of AEGR-733 on hepatic fat levels. It also plans to begin a Phase III trial in HoFH by the end of the year.
AEGR-427, licensed from Bayer Healthcare, a subsidiary of Bayer 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.Aegerion is planning to initiate three Phase II trials with AEGR-427 in 2008.
Aegerion also will need to conduct preclinical studies to assess the risk for pulmonary phospholipidosis associated with long-term use of its drugs, thanks to recent FDA interest in that issue. In June, the agency instituted a partial clinical hold on MTP inhibitor trials longer than six months, although Aegerion noted that none of its planned Phase II trials will exceed six months and it has obtained a waiver for its planned Phase III trial.
Even so, the agency requested that Aegerion complete toxicology and electron microscopy analyses, which are slated for the first half of 2008. The company also plans to monitor pulmonary function throughout its trials. Aegerion said in its filing that more than 20 FDA-approved drugs have shown evidence of pulmonary and other forms of phospholipidosis in preclinical animal studies, but neither AEGR-733 nor AEGR-427 has been linked to any complication of pulmonary function in prior trials.
Aegerion reported a net loss of $16 million for the nine months ended Sept. 30 and $25 million since its February 2005 inception. Cash and equivalents at Sept. 30 totaled $14.6 million.
In other financing news:
• Bioxel Pharma Inc., of Ste-Foy, Quebec, raised C$3.66 million (US$3.75 million) through the private placement of 15 percent convertible unsecured debentures due 2014. The debentures are convertible into common shares at a conversion price of C16 cents per share in the first two years, increasing by 10 percent each subsequent year. As part of the offering, holders received 22.9 million warrants to purchase an equal number of common shares at an exercise price of C16 cents per share for two years from the date of closing. Additionally, the company restructured debt related to convertible debentures issued in July 2002. Bioxel develops and markets taxane-based products and active pharmaceutical ingredients. Shares (CDNX:BIP) fell C3 cents, or 15.6 percent, to close at C14 cents on Wednesday.