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Coartem® receives
FDA approval becoming first artemisinin-based combination treatment (ACT)
for malaria in the US
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.
# # #
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