[Ip-health] PRESS RELEASE: Pyramax(R), a new antimalarial combination, receives positive opinion from European Medicines Agency

Elizabeth Poll polle at mmv.org
Sun Feb 19 21:50:30 PST 2012


   PRESS RELEASE: Pyramax®, a new antimalarial combination, receives
positive opinion from European Medicines Agency

Dear Colleagues,

We would like to share our latest exciting news with you: Pyramax®, a new
antimalarial combination, has received positive opinion from the European
Medicines Agency.

Pyramax®, developed by Shin Poong Pharmaceutical Co. Ltd and Medicines for
Malaria Venture, is the first artemisinin combination therapy (ACT) to be
approved by a stringent regulatory authority for the treatment of both******
* P. falciparum* and******* P. vivax* malaria, and the only ACT with trials
in******* P. vivax* malaria conducted to stringent regulatory standards.
The new medicine will be an important additional tool for WHO’s artemisinin
resistance containment strategy.

Please find attached the press release (also included below) and a fact
sheet on the new medicine.

Kind regards,
Lizzie

***PRESS RELEASE*

*Pyramax®, a new antimalarial combination, receives positive opinion from
European Medicines Agency*

*Geneva, 20 February 2012**:* Pyramax®, a fixed-dose combination of
pyronaridine and artesunate, becomes the first antimalarial to be granted a
positive scientific opinion from the European Medicines Agency (EMA) under
Article 58. This once daily, 3-day treatment is indicated for acute,
uncomplicated* Plasmodium falciparum* and blood stage* Plasmodium
vivax* malaria
in adults and children over 20 kg.

*Pyramax* tablets are the result of collaboration between the product
development partnership Medicines for Malaria Venture, and Shin Poong
Pharmaceutical Co. Ltd., Republic of Korea. The approval is based upon
clinical trials comparing the safety and efficacy of* Pyramax* to that of
artemether-lumefantrine and a loose combination of artesunate and
mefloquine for* P. falciparum* malaria, and versus chloroquine for* P. vivax
* malaria.

It is the first artemisinin combination therapy (ACT) to be approved by a
stringent regulatory authority for the treatment of both* P. falciparum* and
* P. vivax* malaria, and the only ACT with trials in* P. vivax* malaria
conducted to stringent regulatory standards*.*

“EMA’s positive scientific opinion of* Pyramax* comes at a critical time,”
said David Reddy, CEO of MMV. “Parasite resistance to artemisinin, as well
as to the partner drugs in some ACTs, is on the rise and a new alternative
is urgently needed.* Pyramax* can help fill that urgent need and the
positive opinion will help ensure its availability in areas where other
ACTS are failing. Our next step is to ensure that healthcare workers
understand how to appropriately use the drug. We will also work to complete
development of paediatric formulations of this new combination.”

Initially,* Pyramax* will be registered in countries with areas of low
malaria transmission where there is reported artemisinin resistance and
diminished efficacy of other ACTs. It will be an important additional tool
for WHO’s artemisinin resistance containment strategy in these countries,
where its use will also facilitate the collection of more information on
this combination. As liver enzyme elevations were noted in some subjects,
until further data after retreatment is obtained, it is recommended that*
Pyramax* be administered not more than once.

Taking over the project from WHO/TDR in 2002, when* Pyramax* was entering
preclinical trials, MMV embarked on a partnership with Shin Poong.  Since
then, the partnership has taken the drug through early clinical studies
leading to four successful, pivotal Phase III clinical trials with over
3,500 patients in 18 countries in sub-Saharan Africa, Southeast Asia and
India. In addition, safety and efficacy has been confirmed for the*
Pyramax* paediatric
granules formulation in children as young as 6 months and work is on-going
to submit the dossier in the near future.

“The managerial decision to commence the*** Pyramax* project was based on
Shin Poong’s core values and company policies, which have guided us for
nearly half a century,” said Mr. Chang Kyun Kim, President of Shin Poong.
“It represents an effort to fulfil our corporate social responsibilities
and to realize universal values. To advance these values, Shin Poong will
extensively collaborate with the WHO to register*** Pyramax* in
malaria-endemic countries and supply*** Pyramax* at an affordable price so
that many lives, especially those of children, can be saved and the general
public’s health can be maintained.”*** *

***Disclaimer*

This document contains certain forward-looking statements that may be
identified by words such as ‘believes’, ‘expects’, ‘anticipates’,
‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar
expressions, or by discussion of, among other things, vision, strategy,
goals, plans, or intentions. It contains hypothetical future product target
profiles, development timelines and approval/launch dates, positioning
statements, claims and actions for which the relevant data may still have
to be established. Stated or implied strategies and action items may be
implemented only upon receipt of approvals including, but not limited to,
local institutional review board approvals, local regulatory approvals, and
following local laws and regulations. Thus, actual results, performances or
events may differ from those expressed or implied by such statements.

We ask you not rely unduly on these statements. Such forward-looking
statements reflect the current views of Medicines for Malaria Venture (MMV)
and its partner(s) regarding future events, and involve known and unknown
risks and uncertainties.



MMV accepts no liability for the information presented here, nor for the
consequences of any actions taken on the basis of this information.
Furthermore, MMV accepts no liability for the decisions made by its
pharmaceutical partner(s), the impact of any of their decisions, their
earnings and their financial status.

**

*For further information please contact:*

Paul Cheon

Director, Pyramax Team, Shin Poong Pharmaceutical Co., Ltd. Seoul, Korea

Tel: +822 2189 3471
Mob: +8210 6306 0184

Email: *jung1 at shinpoong.co.kr* <jung1 at shinpoong.co.kr>



Jaya Banerji

Director, Advocacy & Communications

Tel: +41 22 799 4071
Mob: +41 79 707 7181
Email: *banerjij at mmv.org* <banerjij at mmv.org>

**

*Notes for Editors*

Article 58 of Regulation (EC) No
*726/2004*<http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:349:0034:0035:EN:PDF>was
created in 2004. Technically, it establishes a mechanism for the EMA
to
give a scientific opinion, in cooperation with the World Health
Organization (WHO), for the evaluation of medicinal products intended
exclusively for markets outside the (European) Community (Regulatory
Reference, s.d.).

****

*Reference*

Regulatory Reference, n.d.* EMA Article 58.* [Online]
Available at:* http://regulatoryreference.com/IND/ema_article_58*
[Accessed 11 January 2012].

**

*To view the** Pyramax** safety and efficacy statement as well as further
information regarding MMV and Shin Poong see the attached press release. *

 <<...>> <<...>>

Elizabeth Poll
Editor and Publications Officer
T +41 22 799 45 81
M +41 79 907 59 92
F +41 22 799 40 61
***polle at mmv.org* <polle at mmv.org>
...........................................................................

***Sign-up for our e-news and keep up-to-date with MMV's
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********Defeating Malaria Together*********

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