Novartis discontinues ASA404 clinical trial program and shifts focus to other cancer compounds in early and late stage development
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Novartis International AG /
Novartis discontinues ASA404 clinical trial program and shifts focus to other
cancer compounds in early and late stage development
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* Interim results from Phase III trial show ASA404 failed to meet primary
endpoint of extending survival for the second-line treatment of non-small
cell lung cancer
* Related impairment charges of approximately USD 120 million to be taken in
fourth quarter 2010
Basel, November 11, 2010 - Novartis announced today that the clinical trial
program for the investigational cancer treatment ASA404 (vadimezan) will be
discontinued and resources will be reallocated to other compounds in the
oncology pipeline. The decision was made after interim results from a Phase III
trial showed that ASA404 would not likely meet the primary endpoint of
significantly extending overall survival when used in combination with
chemotherapy for the second-line treatment of patients with advanced non-small
cell lung cancer (NSCLC).
The study, called ATTRACT-2 (Antivascular Targeted Therapy: Researching ASA404
in Cancer Treatment), included patients with advanced (stage IIIb/IV) NSCLC of
squamous or nonsquamous histology who experienced disease progression on or
following an initial chemotherapy regimen. The trial has been stopped early
based on a recommendation from an independent data monitoring committee.
Investigators involved in the study and regulatory agencies have been notified
of the decision to stop the trial. Novartis does not plan to proceed with
regulatory filings based on these data.
An intangible asset impairment charge of approximately USD 120 million will be
taken in the fourth quarter of 2010 in the Novartis Pharmaceuticals division.
About ASA404
ASA404 (vadimezan) is a tumor-vascular disrupting agent (tumor-VDA). Novartis
signed an exclusive licensing agreement with Antisoma plc for the worldwide
rights to ASA404 in April 2007. In March 2010, ASA404 also failed to meet the
primary endpoint in the ATTRACT-1 trial, which evaluated ASA404 in combination
with paclitaxel and carboplatin as first-line treatment for advanced (stage
IIIb/IV) NSCLC of squamous or nonsquamous histology.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "development," "to be taken," "will," "pipeline," "plan,"
or similar expressions, or by express or implied discussions regarding potential
future sales or earnings or financial results of the Novartis Group or any of
its divisions. 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 that the Novartis Group, or any of its divisions, will
achieve any particular financial results. In particular, management's
expectations could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally; 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; competition in
general; government, industry and general public pricing pressures;
uncertainties regarding actual or potential legal proceedings, including, among
others, product liability litigation, litigation regarding sales and marketing
practices, government investigations and intellectual property disputes;
uncertainties regarding the ongoing government debt crisis and the after-effects
of the recent global financial and economic crisis; uncertainties regarding
future global exchange rates and uncertainties regarding future demand for our
products; uncertainties involved in the development of new pharmaceutical
products; 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, cost-
saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100.000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Amy Vinci
Novartis Global Media Relations Novartis Oncology
+41 61 324 7999 (direct) +1 862 778 6309 (direct)
+41 79 593 4202 (mobile) amy.vinci(at)novartis.com
eric.althoff(at)novartis.com
e-mail: media.relations(at)novartis.com
Novartis Investor Relations
Central phone: +41 61 324 7944
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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
[HUG#1461276]
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Novartis International AG
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Unternehmensinformation / Kurzprofil:
Datum: 11.11.2010 - 07:15 Uhr
Sprache: Deutsch
News-ID 48648
Anzahl Zeichen: 8226
contact information:
Town:
Basel
Kategorie:
Business News
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