Aegerion Pharmaceuticals Announces Final Lomitapide (AEGR-733) Phase II Data

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Tue Jun 16, 2009 8:30am EDT

Results Confirm Preliminary Data and Demonstrate Strong Efficacy, Safety and
Tolerability Profile of Lomitapide
BRIDGEWATER, N.J.--(Business Wire)--
Aegerion Pharmaceuticals, Inc., a biopharmaceutical company focused on the
treatment of cardiovascular and metabolic disease, today announced final data
from three separate Phase II trials involving its lead cholesterol management
compound, lomitapide (AEGR-733), which is a microsomal triglyceride transfer
protein inhibitor (MTP-I) small molecule drug. The final data was recently
presented at the American Diabetes Association`s "69th Scientific Sessions" in
New Orleans, LA on June 7, 2009 and the International Symposium on
Atherosclerosis (ISA) in Boston, MA on June 15, 2009. 

The three trials ranged in duration from 8 to 12 weeks and collected clinical
data on more than 460 patients who suffer from dyslipidemia, a condition in
which there are abnormal levels of lipids in the bloodstream. All three Phase II
trials examined the efficacy, safety and tolerability of lomitapide when
administered in low doses, ranging from 2.5mg to 10mg, both alone and in
combination with lipid lowering therapies (LLTs) such as Lipitor, Zetia and
fenofibrate. 

The final data confirm the preliminary results Aegerion announced in November
2008 and demonstrate the strong efficacy, safety and tolerability profile of
lomitapide, including:

* Significant reductions in patients` low-density-lipoprotein cholesterol
(LDL-C) when administered at the high end of the tested dose range; patients
experienced reductions of up to 35% vs. baseline when used as a monotherapy and
up to 66% from baseline in combination with Lipitor 
* Good additivity in LDL-C reduction when combined with Zetia and fenofibrate 
* Strong decreases in triglyceride levels of up to 40% when used as a
monotherapy and up to 50% in combination with Lipitor 
* Weight loss of up to 3.0% in generally overweight patients (BMIs of 25-30
kg/m2) from the study after 12 weeks on therapy 
* A rate of discontinuation due to liver function test (LFT) elevations of less
than 2.0% 
* Modest increases in hepatic fat with mean levels of 5.1-9.8% and median levels
of 2.4-8.0% 
* Minimal gastrointestinal adverse event discontinuations (less than 5.0%) when
dose titration is utilized

Bill Sasiela, Chief Medical Officer of Aegerion Pharmaceuticals, said, "We are
pleased to receive confirmation of our original findings from November, which
suggest that lomitapide can safely and effectively lower LDL-C and triglycerides
in patients with elevated lipids. Importantly, the full collection of Phase II
trials conducted in the low end of lomitapide`s dose range, which involved
nearly 550 patients, indicate that patients can achieve significant reductions
in LDL-C when using lomitapide with statin therapies like Lipitor. Additionally,
these data show that combining lomitapide with other non-statin drugs like Zetia
could provide meaningful LDL-C reductions in patients that cannot tolerate
statin therapy. In both cases, we see an improved safety profile over prior high
dose MTP-I development efforts." 

As announced on June 15, 2009, Aegerion is currently conducting a Phase III
trial designed to evaluate the efficacy, safety and tolerability of lomitapide
for the treatment of patients with Homozygous Familial Hypercholesterolemia
(HoFH), a rare and extremely serious condition resulting in severely elevated
levels of LDL cholesterol which leads to life-threatening cardiovascular events.
The preliminary data from the trial indicate statistically significant
reductions in patients` LDL-C vs. baseline, while at the same time reporting a
promising safety and tolerability profile, including low levels of hepatic fat
accumulation. For more information on this announcement, please visit
www.aegerion.com. 

About LOMITAPIDE (AEGR-733)

Lomitapide (AEGR-733) is a novel proprietary MTP-inhibitor under development for
the treatment of dyslipidemia (abnormal lipid levels in the bloodstream).
Inhibiting the MTP enzyme reduces blood levels of cholesterol and triglyceride
by limiting the production of lipoproteins from the intestine and liver. 

About Aegerion Pharmaceuticals, Inc.

Aegerion Pharmaceuticals, Inc. is a privately held biopharmaceutical company
focused on the development and commercialization of promising pharmaceuticals to
treat cardiovascular and metabolic disease. The Company`s primary focus is on
hyperlipidemia. Its most advanced products have demonstrated significant LDL
lowering activity in human trials and are currently in Phase III testing. 





Company:
Aegerion Pharmaceuticals, Inc.
Will Lewis, 908-707-2100
Co-Founder and Chief Financial Officer
or
Media:
Sard Verbinnen & Co.
Jim Barron/Lesley Bogdanow/Nick Lawler
212-687-8080 

Copyright Business Wire 2009

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