CAMBRIDGE, Mass., May 31, 2013 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), a biopharmaceutical company dedicated to the development and commercialization of novel, life-altering therapies for patients with debilitating, often fatal, rare diseases, announced today that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion with a unanimous vote recommending a marketing authorization for LOJUXTA™ (lomitapide) hard capsules. If approved, LOJUXTA will be indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH).
The European Commission (EC) needs to ratify the positive opinion from CHMP to grant marketing authorization for LOJUXTA in all 27 European Union member countries. A decision is expected from the European Commission in the third quarter of 2013.
"The positive CHMP opinion for LOJUXTA marks a significant milestone for patients in the EU with HoFH who currently have limited treatment options available that can bring their LDL-C levels to goal," said Marc D. Beer, Chief Executive Officer of Aegerion. "We will continue to prepare for commercial launch in the EU on a country-by-country basis, and look forward to delivering this important new medicine to patients in need in the EU."
HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing low-density lipoprotein cholesterol (LDL-C or "bad" cholesterol) from the body. A loss of LDL receptor function results in extreme elevation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.
Conference Call Details
Aegerion will hold a conference call to provide a business update on Monday, June 3, 2013 at 8:30 a.m. EDT. In addition, the Company will answer questions concerning business developments and trends, and other matters affecting the Company, some of the responses to which may contain information that has not been previously disclosed.
To listen to the conference call, dial (866) 516-3002 (international callers dial (760) 298-5082). In addition, the presentation will be webcast live, and may be accessed for up to 30 days following the call, by visiting the "Investors" section of Aegerion's website, www.aegerion.com.
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. For more information about the company, please visit www.aegerion.com.
This press release contains forward-looking statements, including statements regarding the potential for approval and launch of LOJUXTA in the EU. 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 the EC may not agree with the recommendation of the CHMP or may impose additional restrictions or limitations; the risk that, even if LOJUXTA is approved in the EU, we may not be able to obtain pricing approval in certain countries, or certain countries may impose pricing or other restrictions that limit the commercial potential of LOJUXTA; and the risk that LOJUXTA may not gain market acceptance in the EU. 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.
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Source:Aegerion Pharmaceuticals, Inc.