Novartis study shows QTI571 significantly improved walking distance in patients with life-threatening pulmonary arterial hypertension
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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
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
by terminology such as "potential, " "can, " "estimated, " "committed, " "planned, "
or similar expressions, or by express or implied discussions regarding potential
marketing approvals for QTI571 or regarding potential future revenues from
QTI571. You should not place undue reliance on these statements. Such forward-
looking statements reflect the current views of management regarding future
events, and involve known and unknown risks, uncertainties and other factors
that may cause actual results with QTI571 to be materially different from any
future results, performance or achievements expressed or implied by such
statements. There can be no guarantee that QTI571 will be approved for sale in
any market. Nor can there be any guarantee that QTI571 will achieve any
particular levels of revenue in the future. In particular, management´s
expectations regarding QTI571 could be affected by, among other things,
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; the company´s ability
to obtain or maintain patent or other proprietary intellectual property
protection; unexpected regulatory actions or delays or government regulation
generally; competition in general; government, industry and general public
pricing pressures; the impact that the foregoing factors could have on the
values attributed to the Novartis Group´s assets and liabilities as recorded in
the Group´s consolidated balance sheet, and other risks and factors referred to
in Novartis AG´s current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. Novartis is
providing the information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or otherwise.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, eye care,
cost-saving generic pharmaceuticals, consumer health products, preventive
vaccines and diagnostic tools. Novartis is the only company with leading
positions in these areas. In 2010, the Group´s continuing operations achieved
net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1
billion excluding impairment and amortization charges) was invested in R&D
throughout the Group. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 121,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
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References
[1] Hoeper M, et al. Imatinib in pulmonary arterial hypertension, a randomized,
efficacy study (IMPRES). Data presented at the European Respiratory Society
(ERS) Annual Congress. Abstract No. 413. Presented 25(th) September
2011, 12.15, Room D203 - 204.
[2] Schermuly RT, et al. Reversal of experimental pulmonary hypertension by
PDGF inhibition. J Clin Invest 2005;115:2811-21.
[3] Novartis data analysis.
[4] Desai SA, Channick RN. Exercise in patients with pulmonary arterial
hypertension. J Cardiopulm Rehabil Prev 2008;28:12-16.
[5] Chin KM, Rubin LJ. Pulmonary arterial hypertension. J Am Coll Cardiol
2008;51:1527-38.
[6] Provencher S, et al. Long-term outcome with first-line bosentan therapy in
idiopathic pulmonary arterial hypertension. Eur Heart J 2006;27:589-95.
[7] Miyamoto S, et al. Clinical correlates and prognostic significance of six-
minute walk test in patients with primary pulmonary hypertension.
Comparison with cardiopulmonary exercise testing. Am J Respir Crit Care Med
2000;161:487-492.
[8] Rubin LJ, et al. Bosentan therapy for pulmonary arterial hypertension. N
Engl J Med 2002;346:869-903.
[9] Galiè N, et al. Sildenafil citrate therapy for pulmonary arterial
hypertension. N Engl J Med 2005;353:2148-2157.
[10] Barst RJ, et al. A comparison of continuous intravenous epoprostenol
(prostacyclin) with conventional therapy for primary pulmonary
hypertension. N Engl J Med 1996;334:296-301.
[11] Barst RJ. PDGF signaling in pulmonary arterial hypertension. J Clin Invest.
2005;115:2691-2694.
[12] Grimminger F, Schermuly RT. PDGF receptor and its antagonists: role in
treatment of PAH. Adv Exp Mol Biol 2010;661:435-446.
[13] Balasubramaniam V, et al. Role of platelet-derived growth factor in
vascular remodeling during pulmonary hypertension in the ovine fetus. Am J
Physiol Lung Cell Mol Physiol 2003;284:L826-833.
[14] Ghofrani A, et al. Imatinib in pulmonary arterial hypertension patients
with inadequate response to established therapy. Am J Respir Crit Care Med
2010;182:1171-1177.
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