Novartis and Medicines for Malaria Venture launch Coartem®
Dispersible, the first ACT* developed for children suffering from
malaria
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* More children die from malaria than any other patient group -
every 30 seconds a child dies from malaria
* Approved by Swissmedic, sweet-tasting Coartem® Dispersible is an
easy-to-administer medicine that promotes effective treatment for
children with malaria
* Recent study published in The Lancet shows Coartem Dispersible is
well-tolerated and provides children with high cure rates
comparable to Coartem
* Novartis will provide Coartem Dispersible without profit for
public sector use in malaria-endemic regions
Basel, January 27, 2009 - Novartis and Medicines for Malaria Venture
(MMV) announced today the launch of Coartem® Dispersible, a new
pediatric formulation of Coartem® (artemether/lumefantrine 20 mg/120
mg), for the treatment of uncomplicated malaria in infants and
children.
Coartem Dispersible contains the same amounts of artemether and
lumefantrine as Coartem, the leading artemisinin-based combination
therapy (ACT) in Africa, and is the first dispersible fixed-dose ACT
developed especially for children.
Each year there are more than one million malaria-related deaths
around the world[1]. Nine out of ten malaria deaths occur in sub
Saharan Africa, and the vast majority of malaria-related deaths occur
in children. In Africa alone, a child dies every 30 seconds from
malaria[2].
"This new Coartem Dispersible tablet can help improve treatment and
compliance saving many of the more than 700,000 children under five
who die each year from malaria," said Dr. Daniel Vasella, chairman
and CEO of Novartis. "I am pleased that we can provide a clearly
better formulation to help ensure children with malaria receive and
can take an effective therapy."
Until now, many parents crushed bitter-tasting antimalarial tablets
for their children to swallow. The new sweet-tasting Coartem
Dispersible tablets disperse quickly in small amounts of water,
easing administration and ensuring effective dosing for children.
"The launch of Coartem Dispersible is an important milestone in the
fight against malaria and marks the culmination of several years of
successful collaboration with Novartis," said Dr. Chris Hentschel,
President and CEO of Medicines for Malaria Venture. "As malaria is
essentially a pediatric disease, we are hopeful that this
child-friendly formulation will contribute to a reduction in child
mortality in Africa, and give children back their future."
A phase III study recently published in The Lancet showed that
Coartem Dispersible provides a high cure rate** of 97.8%, which is
comparable to that of Coartem (98.5%). Investigators also reported
that it had a good safety profile[3].
As part of its ongoing commitment to patients and health workers,
Novartis and MMV also provide malaria case management educational
programs, which include hands-on training for local healthcare
workers, customized training manuals, and user-friendly packaging to
ensure that Coartem Dispersible is properly used and to improve
patient compliance. Like Coartem, Coartem Dispersible will be
provided to the public sector without profit to benefit those people
most in need in the developing world. In addition to Swissmedic,
Coartem Dispersible is approved by several regulatory authorities in
Africa. These countries include Benin, Burkina Faso, Democratic
Republic of Congo, Gabon, Ghana, Guinea, Ivory Coast, Kenya,
Madagascar, Mauritania, Niger, Nigeria, Senegal, Togo, and Zambia.
About Coartem
In a unique collaboration with international organizations, Novartis
has provided more than 215 million Coartem treatment courses to the
public sector in Africa without profit since 2001. These treatments
have helped to save approximately 550,000 lives.
Artemisinin is a compound derived from the sweet wormwood plant and
has been used for centuries in traditional Chinese medicine to treat
fever. An ACT is a combination of two or more drugs (one of which is
an artemisinin derivative) that have different modes of action.
Studies have shown that using two or more drugs in combination has
the potential to delay the development of resistance. ACTs in
particular have been found to be highly effective in treating malaria
and their potential to delay resistance in areas of intense
transmission is under investigation.
Disclaimer
The foregoing release contains certain forward-looking statements
that can be identified by terminology such as "will," "hopeful,"
"can," "potentially," "commitment," or similar expressions, or by
express or implied discussions regarding potential additional
marketing approvals for Coartem or Coartem Dispersible, or regarding
potential future revenues from Coartem products. 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 or Coartem
Dispersible will be approved for sale in any additional market. Nor
can there be any guarantee that Coartem products will achieve any
particular levels of revenue in the future. In particular,
management's expectations regarding Coartem products 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; 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, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in these areas. In 2007, the
Group's continuing operations (excluding divestments in 2007)
achieved net sales of USD 38.1 billion and net income of USD 6.5
billion. Approximately USD 6.4 billion was invested in R&D activities
throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 97,000 full-time associates and
operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.
Novartis was named a Super Sector Leader by the Dow Jones
Sustainability Index (DJSI) in 2007. In the same year, 66 million
patients around the world benefited from Novartis programs valued at
USD 937 million. These initiatives range from drug donation and
research programs to combat neglected diseases like malaria,
tuberculosis and leprosy in developing nations, to patient assistance
programs that help cancer patients receive the most innovative and
effective treatments available. For further information, please
consult http://www.novartis.com.
About Medicines For Malaria Ventures
Medicines for Malaria Venture (MMV) is a non-profit organization
created to discover, develop and deliver effective and affordable
antimalarial drugs through public-private partnerships. MMV's vision
is a world in which these innovative medicines will cure and protect
the millions at risk of malaria and help to ultimately eradicate this
terrible disease.
MMV is currently managing the largest-ever portfolio of antimalarial
projects in collaboration with over 100 pharmaceutical, academic, and
endemic-country partners in 38 countries. The portfolio includes 19
completely new classes of compounds. New and improved treatment
solutions are urgently needed for the 2.4 billion people at risk from
malaria. MMV is working to ensure that its products will have the
greatest possible public health impact and, most importantly, save
lives. For more information, please consult http://www.mmv.org.
References
[1] 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.
[2] Malaria Fact Sheet. World Health Organization Web site. Available
at : http://www.who.int/mediacentre/factsheet/fs094/en/.
[3] 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.
* Artemisinin-based combination therapy (ACT)
** Cure rates in the study were PCR-corrected in the mITT population.
# # #
Novartis Media Relations
Eric Althoff Peter Shelby
Novartis Global Media Novartis Pharma Communications
Relations +41 61 324 4470 (direct)
+41 61 324 7999 (direct) +41 79 597 6353 (mobile)
+41 79 593 4202 (mobile) peter.shelby@novartis.com
eric.althoff@novartis.com
e-mail: media.relations@novartis.com
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