CAMBRIDGE, Mass., June 16, 2011 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc.(Nasdaq:AEGR), an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat severe lipid disorders, announced today that the Company concluded a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its investigational drug candidate, lomitapide, for the treatment of homozygous familial hypercholesterolemia (HoFH). Following the meeting, the Company said it intends to proceed with its NDA submission as previously announced.
"The pre-NDA meeting reinforced our understanding of the agency's requirements for our submission," commented Marc D. Beer, Chief Executive Officer of Aegerion Pharmaceuticals. "Based on feedback received during the meeting and in prior correspondence, we are moving forward with our NDA submission for lomitapide according to previously announced plans."
Management will hold a conference call today at 11:00 a.m. ET to discuss the recently announced 56-week data, results of the pre-NDA meeting, and other corporate and regulatory updates.
To listen to the 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, . The conference call will be archived and accessible on the same website shortly after the conclusion of the call.
Lomitapide is a small molecule microsomal triglyceride transfer protein inhibitor being developed as an oral, once-a-day treatment for patients with severe lipid disorders. Lomitapide is being evaluated for its ability to reduce low-density lipoprotein cholesterol, or LDL-C, levels in patients with HoFH and reduce triglyceride levels in patients with familial chylomicronemia, or FC. It reduces lipid levels in the blood by preventing the liver and intestines from secreting lipids into the blood stream.
About Aegerion Pharmaceuticals, Inc.
Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR) is an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat severe lipid disorders. The Company's lead product, lomitapide, is in Phase III clinical development. Lomitapide is initially being developed to treat patients with a rare genetic lipid disorder called homozygous familial hypercholesterolemia, or HoFH. The Company also plans to initiate a clinical program for lomitapide to treat patients with a severe genetic form of hypertriglyceridemia called familial chylomicronemia.
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding expected regulatory filings for and commercialization of the Company's lead product candidate, lomitapide. The forward-looking statements in this release do not constitute guarantees of future performance. These statements are neither promises nor guarantees, and are subject to a variety of risks and uncertainties, many of which are beyond the Company's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. The risks and uncertainties include the Company's history of operating losses; the Company's potential need for additional capital to fund operations and develop its product candidates; uncertainties associated with the clinical development and associated regulatory filings of the Company's product candidates, including the risk that the Company's regulatory filings may be delayed or may not be accepted by the applicable regulatory authorities; the risk that the Company's product candidates may not be approved for any indication or, if approved, that the approved definition of the targeted patient populations for the Company's product candidates may be narrower than expected; risks associated with undesirable side effects experienced by some patients in clinical trials for the Company's product candidates; risks associated with the Company's lack of sales and marketing experience; the highly competitive industry in which the Company operates; risks associated with the Company's intellectual property rights and the extent to which such intellectual property rights protect the Company's product candidates; the risk that third parties may allege that the Company infringes their intellectual property rights or that the Company has failed to comply with the provisions of its in-license agreements; risks associated with the Company's reliance on third parties, in particular clinical research organizations and contract manufacturers; risks associated with the Company's ability to recruit, hire and retain qualified personnel; and risks associated with volatility in the Company's stock price as a newly public company. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes 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. For additional disclosure regarding these and other risks faced by the Company, see the disclosure contained in the Company's public filings with the Securities and Exchange Commission, including the Company's recent Annual Report on Form 10-K under the heading "Risk Factors" and available on its investor relations website at http://www.aegerion.com and on the SEC's website at http://www.sec.gov.
CONTACT: Aegerion Pharmaceuticals, Inc. Corporate Mark Fitzpatrick, Chief Financial Officer +1 (617) 500-6235 LaVoie Group, Inc. Investors & Media Amanda Murphy +1 (978) 745-4200 x107 email@example.com