Novartis announces termination of ALTITUDE study with Rasilez®/ Tekturna® in high-risk patients with diabetes and renal impairment
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Novartis International AG /
Novartis announces termination of ALTITUDE study with Rasilez®/ Tekturna® in
high-risk patients with diabetes and renal impairment
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The issuer is solely responsible for the content of this announcement.
* ALTITUDE study involved patients with type 2 diabetes and renal impairment
who are at high risk of cardiovascular and renal events
* Committee overseeing study identified higher adverse events when
Rasilez/Tekturna was added to an ACE or ARB drug in this patient population
* Patient safety is the highest priority and Novartis is in dialogue with
health authorities worldwide. Patients should contact their health care
provider if they have any concerns
* Assessment of results of the ALTITUDE study and the potential implications
for Rasilez/Tekturna-based products* is ongoing
Basel, December 20, 2011 - Novartis announced that following the seventh interim
review of data from the ALTITUDE study with Rasilez(®)/Tekturna(®) (aliskiren),
a decision to terminate the trial has been taken on the recommendation of the
independent Data Monitoring Committee (DMC) overseeing the trial.
The DMC concluded that patients were unlikely to benefit from treatment added on
top of standard anti-hypertensives, and identified higher adverse events in
patients receiving Rasilez/Tekturna in addition to standard of care in the
trial. Specifically, in the trial arm in which Rasilez/Tekturna was added to the
standard of care there was an increased incidence after 18-24 months of non-
fatal stroke, renal complications, hyperkalemia and hypotension in this high-
risk study population.
The placebo-controlled Phase III ALTITUDE study is the first trial to
investigate Rasilez/Tekturna for more than one year in a specific population of
patients with type 2 diabetes and renal impairment. These patients are known to
be at high risk of cardiovascular and renal events. In the study,
Rasilez/Tekturna was given in addition to optimal cardiovascular treatment
including an angiotensin converting enzyme (ACE) inhibitor or angiotensin
receptor blocker (ARB).
Novartis is in ongoing discussions with health authorities worldwide about the
implications of the findings from ALTITUDE for patients. As a precautionary
measure Novartis will cease promotion of Rasilez/Tekturna-based products for use
in combination with an ACE-inhibitor or ARB.
"Patient safety is the highest priority for Novartis, and we are in a dialogue
with health authorities worldwide," said David Epstein, Division Head of
Novartis Pharmaceuticals.
Novartis is recommending that ALTITUDE investigators remove Rasilez/Tekturna-
based products from their patients' treatment regimen and review their high
blood pressure medication. Novartis is also reviewing the findings with DMCs of
other clinical studies involving Rasilez/Tekturna-based products and combination
therapies.
Patients in ALTITUDE should contact their study site for guidance on medication
and should not stop treatment until they have seen their physician in view of
the importance of controlling high blood pressure. Any patients using
Rasilez/Tekturna or other aliskiren combination products who may have questions
about their medication should consult their healthcare provider. For more
information visitwww.novartis.com.
Total sales of Rasilez/Tekturna-based products for the first nine months of
2011 were USD 449 million (1% of Novartis Group sales) and are likely to be
negatively impacted by the study results going forward. Product profitability in
2011 was negative. A further update of the actual financial implications will be
communicated when the regulatory dialogue has been concluded.
* includes Rasilez(®)/Tekturna(®); Rasilez HCT(®)/Tekturna HCT(®); Valturna(®);
Rasilamlo(®)/Tekamlo(®); Rasitrio(®)/Amturnide(®
)
About Aliskiren
Aliskiren was approved in 2007 in the EU and US under the brand-names Rasilez
and Tekturna respectively, for the treatment of hypertension (high blood
pressure) either as monotherapy or in combination with other medications. The
efficacy and safety of Rasilez/Tekturna have been investigated in more than
57,000 patients who have been treated with this medicine in clinical studies.
Rasilez/Tekturna-based products include:
* Rasilez®/Tekturna®
* Rasilez HCT®/Tekturna HCT®, a single-pill combination of Rasilez/Tekturna
and hydrochlorothiazide (HCT)
* Valturna®, a single-pill combination of Rasilez/Tekturna and valsartan,
available in the US only
* Rasilamlo®/Tekamlo®, a single-pill combination of Rasilez/Tekturna and
amlodipine
* Rasitrio®/Amturnide®, a triple combination of Rasilez/Tekturna, amlodipine
and hydrochlorothiazide (HCT)
About ALTITUDE
ALTITUDE was a multinational study in 8,606 patients from 36 countries
evaluating the potential benefits of Rasilez/Tekturna to reduce the risk of
cardiovascular and renal events in this patient population.
ALTITUDE was the first randomized, double-blind, placebo-controlled study to
investigate Rasilez/Tekturna for more than one year in a specific population of
patients with type 2 diabetes and renal impairment. These patients are known to
be at high risk of cardiovascular and renal events. In the study,
Rasilez/Tekturna was given in addition to optimal cardiovascular treatment
including an angiotensin converting enzyme (ACE) inhibitor or angiotensin
receptor blocker (ARB).
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," "ongoing," "will," "likely," or similar
expressions, or by express or implied discussions regarding the potential impact
of our dialogue with worldwide health authorities on the future of
Rasilez/Tekturna-based products; regarding potential future revenues from
Rasilez/Tekturna-based products; or regarding the potential financial impact on
Novartis of the matters described in this release. 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 to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee as to the
outcome of our dialogue with worldwide health authorities on the future of
Rasilez/Tekturna-based products. Nor can there be any guarantee regarding the
levels of revenue or profitability that Rasilez/Tekturna-based products might
achieve in the future. Neither can there be any guarantee as to the ultimate
financial impact on Novartis of the matters described in this release. In
particular, management's expectations regarding these matters could be affected
by, among other things, unexpected regulatory actions or delays or government
regulation generally; unexpected clinical trial results, including unexpected
additional analysis of the existing ALTITUDE clinical data and unexpected new
clinical data; 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 innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global 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. 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.
Novartis is on Twitter. Sign up to follow (at)Novartis
athttp://twitter.com/novartis.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff John Taylor
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 324 6715 (direct)
+41 79 593 4202 (mobile) +41 79 593 4279 (mobile)
eric.althoff(at)novartis.com john.taylor(at)novartis.com
Novartis Investor Relations
Central phone: +41 61 324 7944
Susanne Schaffert +41 61 324 7944 North America:
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Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445
Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456
e-mail: investor.relations(at)novartis.com e-mail:
investor.relations(at)novartis.com
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Source: Novartis International AG via Thomson Reuters ONE
[HUG#1572562]
Unternehmensinformation / Kurzprofil:
Datum: 20.12.2011 - 07:16 Uhr
Sprache: Deutsch
News-ID 98547
Anzahl Zeichen: 11518
contact information:
Town:
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Kategorie:
Business News
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