Healthcare Industry News: Renagel
News Release - February 7, 2011
Aegerion Pharmaceuticals Appoints Martha J. Carter as Chief Regulatory OfficerPharmaceutical Industry Veteran Adds Extensive Regulatory Expertise
CAMBRIDGE, Mass., Feb. 7, 2011 -- (Healthcare Sales & Marketing Network) -- Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR ), an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat severe lipid disorders, announced the appointment of Martha J. Carter to its executive team as Chief Regulatory Officer.
Ms. Carter was most recently Senior Vice President & Chief Regulatory Officer at Proteon Therapeutics, Inc. where she was responsible for the company's worldwide regulatory and quality functions. Prior to this role, she was Senior Vice President, Regulatory Affairs, for Trine Pharmaceuticals. Prior to that, Ms. Carter was Vice President, Regulatory Affairs for GelTex Pharmaceuticals, Inc. In this role, she led the company's regulatory and quality control functions for both commercial and investigational drug products.
Aegerion's Chief Executive Officer Marc Beer commented, "Martha brings over 30 years of regulatory and quality assurance experience to Aegerion, and we welcome her to the management team. Her success with approval for drugs such as Neumega(R), WelChol(R), and Renagel(R) bolsters our confidence as we prepare the NDA and MAA filings for our drug candidate lomitapide, and bring it through to commercialization."
Ms. Carter added, "I am thrilled to be joining Aegerion at this exciting time in the Company's history, with the FDA and EMA filings on the near-term horizon. I look forward to focusing my efforts on a thorough submission and review, to bring this product to the over six thousand HoFH patients in need of an effective therapy."
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 (FC).
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of 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. In particular, the risks and uncertainties include, among other things: our history of operating losses; our potential need for additional capital to fund operations and develop our product candidates; uncertainties associated with the clinical development and associated regulatory filings of our product candidates, including the risk that our regulatory filings may not be accepted by the applicable regulatory authorities, the risk that our product candidates may not be approved for any indication, or if approved, the risk that the finally approved definition of the targeted patient populations for our product candidates may be narrower than we expect; risks associated with undesirable side effects experienced by some patients in clinical trials for our product candidates; risks associated with our lack of sales and marketing experience; the highly competitive industry in which we operate; risks associated with our intellectual property rights and the extent to which such intellectual property rights protect our product candidates; the risk that third parties may allege that we infringe their intellectual property rights or that we have failed to comply with the provisions of our in-license agreements; risks associated with our reliance on third parties, in particular clinical research organizations and contract manufacturers; risks associated with our ability to recruit, hire and retain qualified personnel; and risks associated with volatility in our 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 our public filings with the Securities and Exchange Commission, including the Company's most recent Quarterly Report on Form 10-Q 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.
Source: Aegerion Pharmaceuticals
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