Novartis malaria treatment Coartem® 80/480mg receives WHO prequalification, enabling greater access for patients
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Novartis International AG /
Novartis malaria treatment Coartem® 80/480mg receives WHO prequalification,
enabling greater access for patients
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* WHO prequalified Coartem(®) 80/480mg is the first and only high strength
malaria treatment available for donor-funded public sector procurement
* Coartem(®) 80/480mg reduces the pill burden for patients, potentially
improving adherence to treatment and clinical outcomes
* This follows the launch of the first fixed-dose ACT and the first child
friendly ACT formulation, underscoring the ongoing innovation of Novartis in
malaria treatment
Basel, Switzerland, July 16, 2015 - Novartis antimalarial medicine Coartem(®)
80/480mg today received World Health Organization (WHO) prequalification, making
it the first and only high strength (80/480mg) Artemisinin-based Combination
Therapy (ACT) antimalarial treatment available for public sector procurement.
This new dosage strength*, has the potential to improve malaria management. WHO
prequalification of Coartem(®) 80/480mg now allows for broad-scale public sector
procurement, possibly providing access to the treatment to as many as 25 million
malaria sufferers across Africa.
"Over the last ten years, Novartis has worked with partners to make Coartem(®)
treatments available to patients in the public sector and through donor-funded
private sector programs," said Joseph Jimenez, CEO of Novartis. "WHO
prequalification of Coartem(®) 80/480mg aligns with the longstanding work of the
Novartis Malaria Initiative and confirms the company's status as a leading
innovator in malaria treatment."
Although preventable and treatable, malaria was responsible for approximately
584,000 deaths in 2013[1]. One Coartem(®) 80/480mg tablet is bioequivalent to
four tablets of Coartem(®) 20/120mg**[2], resulting in a lower pill burden for
patients - six tablets for completion of the course of treatment, compared to
the previous 24. Studies have shown that patient adherence to ACTs varies
considerably, from 39% to 100%[3]. Failure to complete the full treatment course
may reduce treatment efficacy and allow malaria parasites to develop resistance
to the drug. The reduction in the number of tablets associated with Coartem(®)
80/480mg could increase convenience and overcome the challenges associated with
therapies that require taking a large number of pills, therefore improving
adherence to treatment and clinical effectiveness.
"We welcome the arrival of high-strength Coartem(®) 80/480mg said Dr Nafo
Traoré, Executive Director of Roll Back Malaria Partnership. "By reducing the
number of pills that adults have to take, we hope to see better adherence to
treatment regimens, helping us to combat this preventable and treatable disease
which still kills hundreds of thousands of people."
Coartem(®) 80/480mg, which received Swissmedic approval in November 2013, was
launched in the private sector in Nigeria in late 2013 and has since been
launched in more than ten African countries. This latest formulation highlights
the efforts of Novartis to expand access to essential malaria treatments for all
ages: in 2004 Coartem(®) 20/120mg was the first fixed-dose ACT prequalified by
the WHO and in 2009, Coartem(®) Dispersible was launched as the first
dispersible ACT designed specifically for infants and children. Today, more than
700 million treatments, including 250 million Coartem(®) Dispersible
antimalarials, have been delivered without profit to malaria-endemic countries.
About the Novartis Malaria Initiative
The Novartis Malaria Initiative is one of the pharmaceutical industry's largest
access-to-medicines programs, focused on treatment, access, capacity-building
and research & development. Over the last decade, the initiative has delivered
more than 700 million treatments without profit, mostly to the public sector.
Moving forward, Novartis is committed to working towards malaria elimination by
driving the development of next-generation antimalarials, with two new classes
of drugs currently in Phase II clinical development. For more information,
please visit: www.malaria.novartis.com.
Disclaimer
This press release contains expressed or implied forward-looking statements,
including statements that can be identified by terminology such as
"potentially," "ongoing," "potential," "possibly," "may," "could," "efforts,"
"moving forward," "committed," "next-generation," "currently," or similar
expressions. Such forward-looking statements reflect the current views of the
Group 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 expressed or implied by such statements. These
expectations could be affected by, among other things, risks and factors
referred to in the Risk Factors section of Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. Novartis is providing the
information in this press release as of this date and does not undertake any
obligation to update it in the future.
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 and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2014, the Group achieved net
sales of USD 58.0 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 120,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please
visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
* Approved for adults and children (weighing above 35 kg and older than 12
years) with uncomplicated Plasmodium falciparum (P. falciparum) malaria
** Coartem® 80/480mg is made up of 80mg artemether and 480mg lumefantrine.
Coartem® 20/120mg is made up of 20mg artemether and 120mg lumefantrine
References
[1] World Health Organization, Malaria. Available at:
http://www.who.int/mediacentre/factsheets/fs094/en/. Date accessed: April 2015.
[2] Lefèvre G. et al, 2013. Evaluation of two novel tablet formulations of
artemether-lumefantrine (Coartem(®)) for bioequivalence in a randomized, open-
label, two-period study. Malaria Journal, 12:(312): 1475-2875.
[3] Banek K. et al, 2014. Adherence to artemisinin-based combination therapy for
the treatment of malaria: a systematic review of the evidence. Malaria Journal,
13(1): 7.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Liz Power Nadine Schecker
Novartis Global Media Relations Novartis Malaria Initiative Communications
+1 212 830 2466 (direct) +41 61 696 8633 (direct)
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Samir Shah +41 61 324 7944 North America:
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Thomas Hungerbuehler +41 61 324 8425 Sloan Pavsner +1 212 830 2417
Isabella Zinck +41 61 324 7188
e-mail: investor.relations(at)novartis.com e-mail:
investor.relations(at)novartis.com
Media release (PDF):
http://hugin.info/134323/R/1939182/699488.pdf
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[HUG#1939182]
Unternehmensinformation / Kurzprofil:
Datum: 16.07.2015 - 07:15 Uhr
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News-ID 407176
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