Aegerion Pharma Offers Updates Ahead of US Launch of JUXTAPID Caps

Loading...
Loading...
Aegerion Pharmaceuticals, Inc.
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. Financial Guidance 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.
Loading...
Loading...
Market News and Data brought to you by Benzinga APIs
Posted In: NewsGuidance
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...