Aegerion Pharma Offers Updates Ahead of US Launch of JUXTAPID Caps
Aegerion Pharmaceuticals, Inc. (Nasdaq: AEGR), a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating, often fatal, rare diseases, today announced its business objectives for 2013 in conjunction with the 31^st Annual J.P. Morgan Healthcare Conference in San Francisco. Marc Beer, President and Chief Executive Officer, will discuss these objectives as part of a live presentation which will be available on Aegerion's website, www.aegerion.com, on Tuesday, January 8 at 2:00 p.m. PST (5:00 p.m. EST).
Expanding the Clinical Development Program of JUXTAPID
During the fourth quarter of 2012, Aegerion initiated enrollment of Japanese subjects into a Phase I bridging study of the pharmacokinetic and pharmacodynamic properties of JUXTAPID. Following the outcome of this study, Aegerion plans to conduct a small therapeutic study of JUXTAPID in Japanese HoFH patients in support of a planned filing for marketing authorization in Japan.
As previously disclosed, the FDA has established a post-marketing requirement for Aegerion to conduct a juvenile toxicology study in rodents. The study will seek to ascertain the impact, if any, of JUXTAPID on growth and development prior to initiating a clinical study of JUXTAPID in pediatric patients. Following the completion of the nonclinical study, the company expects to begin a clinical trial in pediatric patients in 2014.
Advancing Regulatory Activities for JUXTAPID
During 2012, Aegerion submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), requesting approval to market lomitapide as an adjunct to a low-fat diet and other lipid-lowering therapies, with or without apheresis, to reduce LDL-C, total cholesterol, apolipoprotein B, and triglycerides in adults with HoFH. Aegerion continues to anticipate a European Medicines Agency (EMA) decision in mid-2013. If the application is approved, the company will pursue reimbursement on a country by country basis and anticipates commencing commercial activity in Europe by the end of 2013.
Aegerion ended FY 2012 with approximately $78 million to $83 million in cash and cash equivalents. In addition, the Company also announced the following financial guidance:
* Aegerion expects global net revenues of $15 million to $25 million for FY 2013 with 250 to 300 patients on JUXTAPID therapy by year-end 2013. * 18 months post approval of JUXTAPID in the EU, if approved, the Company expects to:
* generate global net revenue at a $100 million annualized run rate; and * achieve cash flow breakeven from operations.
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