The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH. The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined. The safety and effectiveness of JUXTAPID have not been established in pediatric patients.Expanding the Clinical Development Program of JUXTAPID
- 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:
Webcast Aegerion will webcast its corporate presentation at the 31st Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2013 at 2:00 p.m. PST (5:00 p.m. EST). A link to the live webcast will be available and may be accessed for up to 14 days following the conference in the "Investors" section of Aegerion's website, www.aegerion.com . Important Safety Information, including BOXED WARNING which states: WARNING: RISK OF HEPATOTOXICITY JUXTAPID can cause elevations in transaminases. In the JUXTAPID clinical trial, 10 (34%) of the 29 patients treated with JUXTAPID had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or alkaline phosphatase. JUXTAPID also increases hepatic fat, with or without concomitant increases in transaminases. The median absolute increase in hepatic fat was 6% after both 26 and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance spectroscopy. Hepatic steatosis associated with JUXTAPID treatment may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.
- generate global net revenue at a $100 million annualized run rate; and
- achieve cash flow breakeven from operations.