Novartis study shows QTI571 significantly improved walking distance in patients with life-threatening pulmonary arterial hypertension - Seite 2

chronic and rapidly progressive, and can result in right ventricular heart
failure and death[4], [5]. An estimated 260,000 people are affected worldwide[3]
and approximately half of the people diagnosed with PAH die within five
years[5], [11].

"If approved, QTI571 has the potential to provide a further treatment option for
patients where current therapies are not providing sufficient benefit in the
treatment of this life-threatening disease, " said Trevor Mundel, Global Head of
Development in the Pharmaceuticals Division of Novartis. "Novartis has a strong
and growing portfolio of respiratory medicines, and we are committed to
expanding the support we offer to patients suffering from a number of
respiratory and pulmonary disorders."

QTI571 is an oral therapy that works by inhibiting the activity of proliferative
factors including platelet-derived growth factor (PDGF) which is thought to be
involved, along with its receptor, in the progression of PAH[11], [12]. In
patients with this disease, PDGF may cause smooth muscle cells in the pulmonary
arteries to multiply, restricting blood flow and increasing resistance in these
arteries[13].

Safety data showed that the overall incidence of adverse events was similar for
QTI571 and for placebo[1]. Serious adverse events and discontinuations due to
serious adverse events were more frequent with QTI571[1]. Adverse events were as
expected for this patient population and class of drug, and were similar to
those previously reported with QTI571[14].

IMPRES was a 24-week randomized placebo-controlled, double-blind, multi-center
clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on
therapy in the treatment of patients with PAH[1]. The study involved a total of
202 patients with elevated PVR of >=800 dynes.sec.cm(-5) despite treatment with
at least two other specific PAH medications (i.e. endothelin receptor
antagonists, phosphodiesterase-5 inhibitors and/or prostacyclins)[1].

Treatment was initiated at a dose of 200 mg once-daily, which was increased to
400 mg once-daily after two weeks if well tolerated. The dose could be reduced
to 200 mg once-daily if treatment was not well tolerated[1].

QTI571 is currently not approved to treat PAH and is planned to be submitted for
regulatory approval later this year for the treatment of this disease. Imatinib,
the active ingredient in QTI571, is currently available under the trade names
Glivec(®) and Gleevec(®) for use in certain oncology indications.

Disclaimer
The foregoing release contains forward-looking statements that can be identified