Novartis study shows QTI571 significantly improved walking distance in patients with life-threatening pulmonary arterial hypertension

Novartis International AG /
Novartis study shows QTI571 significantly improved walking distance in patients
with life-threatening pulmonary arterial hypertension
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* Phase III IMPRES study demonstrates potential benefits of QTI571 in patients
who remain symptomatic despite treatment with two or more PAH therapies[1]
* Evidence indicates that QTI571 targets an underlying cause of PAH by
counteracting uncontrolled growth of arterial smooth muscle cells[2]
* PAH is a debilitating disease of the heart and lungs affecting up to
260,000 people worldwide[3] leading to heart failure and death[4], [5]

Basel, September 25, 2011 - Novartis announced new data today from the pivotal
Phase III IMPRES clinical trial showing that the investigational therapy QTI571
(imatinib) significantly improved exercise capacity in patients with pulmonary
arterial hypertension (PAH) after 24 weeks compared with placebo[1]. Evidence
indicates that QTI571 targets an underlying cause of PAH by counteracting
uncontrolled growth of arterial smooth muscle cells[2].

The IMPRES study met its primary endpoint by demonstrating a significant
improvement in the six-minute walk distance (6MWD) test in patients with
elevated pulmonary vascular resistance (PVR) despite treatment with two or more
specific PAH vasodilator therapies[1]. The 6MWD is a predictor of survival in
PAH patients[6], [7], and is commonly used to assess exercise capacity in PAH
clinical trials[8], [9], [10]. In the study, patients treated with QTI571
increased their mean 6MWD by 31.8 meters compared with placebo (p=0.002)[1].

The study´s secondary endpoints showed that QTI571 produced statistically
significant improvements compared to placebo in pulmonary arterial pressure,
cardiac output and pulmonary vascular resistance (all p<0.001)[1], but not in
time to clinical worsening (i.e. death, hospitalization due to PAH, worsening of
functional class, or >=15% drop in 6MWD) (p=0.563)[1].

"These results are impressive as they were achieved in patients who were already
receiving two or more established PAH drugs, " said Marius Hoeper MD, Associate
Professor, Department of Respiratory Medicine at Hannover Medical School,
Germany and principal investigator of the IMPRES study. The data were presented
for the first time at the European Respiratory Society (ERS) Annual Congress in
Amsterdam, The Netherlands.

PAH is a debilitating disease of the heart and lungs that is characterized by a
marked and sustained elevation in pulmonary artery pressure. The disease is