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Coartem® receives FDA approval becoming first artemisinin-based
combination treatment (ACT) for malaria in the US |
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Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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* Coartem is highly effective, well tolerated 3-day treatment with
cure rates of over 96%
* More than 235 million Coartem treatments already supplied by
Novartis for public sector use in Africa, helping save an
estimated 600,000 lives
Basel, April 8, 2009 -Coartem® (artemether 20 mg/lumefantrine 120
mg), the leading artemisinin-based combination treatment (ACT) for
malaria worldwide, has been approved by the US Food and Drug
Administration (FDA).
Coartem is a fixed-dose combination of two novel antimalarials. It is
a highly-effective three-day malaria treatment with cure rates of
over 96%[*] even in areas of multi-drug resistance[1],[2].
Each year millions of Americans travel to malaria-endemic regions on
business or pleasure, and this has led to a rise in cases of
'travelers malaria'[3]. Unlike patients in more than 80 countries,
including in many European nations, US patients have not had access
to ACTs like Coartem.
"Around the world, Coartem has eliminated suffering for millions and
saved lives for hundreds of thousands of malaria patients," said Dr.
Daniel Vasella, Chairman and CEO of Novartis. "With a growing number
of malaria cases in the US due to rising travel, it is important to
make ACT treatment such as Coartem, the most effective therapy for
malaria, available to American patients as well."
Each year there are nearly one million malaria-related deaths around
the world. In Africa alone, a child dies every 30 seconds from
malaria[4]. To help alleviate the tremendous problem of access to
treatment, Novartis provides Coartem treatments for public sector use
in Africa without profit. To date, Novartis has provided more than
235 million Coartem treatments, which have helped save an estimated
600,000 lives - mostly children.
"Fighting malaria is very much in America's interest and ACTs such as
Coartem are important weapons against this infectious disease," said
Rear Admiral Tim Ziemer, US Malaria Coordinator. "We welcome FDA
approval of Coartem."
In the US, Coartem will be made available through pharmacies and
hospitals.
Coartem is indicated for the treatment of acute uncomplicated
infections due to plasmodium falciparum, the most dangerous form of
malaria.
Disclaimer
The foregoing release contains certain forward-looking statements
that can be identified by terminology such as "estimated," "will," ,
or similar expressions, or by express or implied discussions
regarding potential additional marketing approvals for Coartem or
regarding potential future revenues from Coartem. You should not
place undue reliance on these statements. Such forward-looking
statements reflect the current views of the Company regarding future
events, and involve known and unknown risks, uncertainties and other
factors that may cause actual results with Coartem to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee
that Coartem will be approved for sale in any additional market. Nor
can there be any guarantee that Coartem will achieve any particular
levels of revenue in the future. In particular, management's
expectations regarding Coartem could be affected by, among other
things, unexpected clinical trial results, including unexpected new
clinical data and unexpected additional analysis of existing clinical
data; unexpected regulatory actions or delays or government
regulation generally; 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; 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 AG 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, preventive vaccines, diagnostic tools,
cost-saving generic pharmaceuticals and consumer health products.
Novartis is the only company with leading positions in these areas.
In 2008, the Group's continuing operations achieved net sales of USD
41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 96,700 full-time-equivalent associates and operate in
more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
References
[1] Hatz C. et al. Treatment of acute uncomplicated falciparum
malaria with arthemeter-lumefantrine in non immune populations: a
safety, efficacy and pharmacokinetic study. Am.J.Trop.Med.Hyg. 2008
[2] Abdulla S. et al. Efficacy and safety of arthemeter-lumefantrine
dispersible tablets compared with crushed commercial tablets in
African infants and children with uncomplicated malaria: a
randomised, single blind, multicentre trial. Lancet . Published on
line.
[3] Malaria Surveillance Report, Centers for Disease Control and
Prevention,; June 20, 2008 / 57(SS05);24-39,
http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5705a2.htm?s_cid=ss5705a2_e
[4] Children and Malaria. World Health Organization Roll Back Malaria
Web site. Available at :
http://www.rbm.who.int/cmc_upload/0/000/015/367/RBMInfosheet_6.pdf.
[5] Malaria Fact Sheet. World Health Organization Web site. Available
at : http://www.who.int/mediacentre/factsheet/fs094/en/.
[*] Cure rates are PCR-corrected in the mITT population. For full
details see reference.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Peter Shelby
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 324 4470 (direct)
+41 79 593 4202 (mobile) +41 79 597 6353 (mobile)
eric.althoff@novartis.com peter.shelby@novartis.com
e-mail: media.relations@novartis.com
Novartis Investor Relations
Central phone: +41 61 324
7944
Ruth Metzler-Arnold +41 61 324 North America:
9980
Pierre-Michel +41 61 324 Richard Jarvis +1 212 830
Bringer 1065 2433
John Gilardi +41 61 324 Jill Pozarek +1 212 830
3018 2445
Thomas Hungerbuehler +41 61 324 Edwin Valeriano +1 212 830
8425 2456
Isabella Zinck +41 61 324
7188
e-mail: e-mail:
investor.relations@novartis.com investor.relations@novartis.com
--- End of Message ---
Novartis International AG
Posfach Basel
WKN: 904278; ISIN:
CH0012005267; Index: SLCI, SMI, SPI, SLIFE;
Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange; Copyright © Hugin AS 2009. All rights reserved.
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