[india-drug] Innovative partnership creating another patent-free malaria drug

["O'Brien Bone & Joint Centre" <obrienbjc@gmail.com>]

Innovative partnership creating another patent-free malaria drug
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Dear friends,

Another good news to help poorer patients around the world.

http://www.ip-watch.org/weblog/index.php?p=1011

Innovative Partnership To Create Another Patent-Free Malaria Drug

By Catherine Saez

After an innovative partnership between an non-governmental group and
a pharmaceutical company led to a new cheap non-patented drug against
malaria being available in Africa in 2007, the model is being
implemented again with another new non-patented anti-malarial drug
being delivered to South American patients.

The Drugs for Neglected Diseases initiative (DNDi), which partnered
with French pharmaceutical company Sanofi-Aventis in 2007, has this
time created a partnership with Farmanguinhos/Fiocruz, the largest
Brazilian public pharmaceutical company.

This partnership is the second phase of the DNDi's Fixed-Dose
Artesunate-based Combination Therapies (FACT) project, a multi-partner
consortium started in 2002 under the umbrella of Médecins sans
Frontières (MSF) with financial support from the European Union, the
Agence Française de Développement, the Dutch, Spanish and United
Kingdom governments, and MSF. The partners include
Farmanguinhos/Fiocruz, French, UK and Thai universities, the Centre
National de Recherche et de Formation sur le Paludisme in Burkina Faso
and the World Health Organization Special Programme for Research and
Training in Tropical Diseases in Switzerland.

The new drug, launched on 17 April in Rio de Janeiro, is named ASMQ
after its two components: artesunate (AS) and mefloquine (MQ). It is a
new unpatented combination drug targeted toward patients suffering
from uncomplicated falciparum malaria in Latin America and Asia. The
combination is one of the four recommended by the World Health
Organization, said DNDi, and is effective in Latin America and Asia
because there is no mefloquine resistance in those continents. The
combination drug is easier to use than two separate treatments, and
ensures that both drugs are taken together and in correct proportion,
DNDi said.

Alternative to Market-based Drug Model

The FACT project, whose 2007 drug was called ASAQ (IPW, Public Health,
5 March 2007), is primarily backed by financing from non-profit
organisations, public institutions and governments. ASMQ is a new
model as it has been produced as a "non-exclusive, not-for-profit
public good" said DNDi.

The ASAQ combination is now being widely used by MSF. "Putting the
tablets together made a huge difference," said Tido von Schoen of MSF.
"It is possible to go without patent" he said, to make a drug a public
good.

Drug research and development being carried out under public funding
is a new model that should lead the way, Ann-Marie Sevcsik, DNDi
scientific communications manager, told Intellectual Property Watch.
"Research and development should be 'needs-driven' instead of
profit-driven, and not only for neglected diseases but for neglected
patients, like cancer patients in the developing world," she said.

ASMQ is now available in Brazil, although the Brazilian government,
due to existing stocks and the registration process will continue
using Coartem, the previously used drug, in 2008. Anti-malarial
treatments are not sold in the private sector in Brazil as they are
sold only through the public distribution system, DNDi said, but there
is an extensive intervention study being conducted by national
authorities, which provides medicines to patients through testing.
Already 20,000 patients have been successfully treated in the Amazon
Basin, which is the location of about 90 percent of Brazilian malaria
patients. Since treatment began there has been a drop of about 70
percent in malaria cases among those patients. There are an estimated
200,000 malaria patients in Brazil, according to DNDi.

Through 2008, more patients will be included in this study and will be
able to receive ASMQ. It will later be available for all patients in
Brazil free of charge. Patients in other Latin America countries will
be able to receive ASMQ by the end of 2008, depending on individual
country registration processed by their regulatory authority.

Patent-free South-South Technology Transfer

According to Jean-René Keichel, DNDi project manager, the FACT project
has encouraged capacity building of the different partners. In Brazil,
for example, it led to the first new molecule developed and registered
by a Brazilian pharmaceutical company. The transfer agreement that is
being carried out between Farmanguinhos/Fiocruz and India's generic
pharmaceutical company Cipla is the first between Brazil and India on
malaria. It is also the first technology transfer project involving a
public pharmaceutical company and a private pharmaceutical company, he
said.

Cipla will address the Asian market and will provide the product at
the at-cost price to the public sector in Asia. The product will be
patent-free.

Farmanguinhos/Fiocruz, with facilitation provided by DNDi, will
transfer information on development and production to Cipla to
manufacture ASMQ. The partners are then expected to share results on
ongoing work and new studies.

Keichel said that the decision to forego patenting on ASAQ and ASMQ
had been made after some discussions within DNDi as there is a risk
the drug could be copied and patented by a private company who could
then prevent DNDi from using it. But they still decided that the FACT
project drugs would remain patent-free, he said.

Sevcsik said DNDi now is sponsoring study in Tanzania to begin by the
end of 2008 to test ASMQ in Africa.

Catherine Saez may be reached at csaez@ip-watch.ch.
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-- 
with warm regards and wishes
girish

Rtn Dr NV Girish Kumar
MBBS Dortho FRCS(Ire) FRCS(Trauma & Ortho)
O'Brien Bone & Joint Clinic
Coimbatore - 641002

Mobile (91) 99430 68388

Pediatric Ortho, Joint Replacement, Arthroscopy, Advanced Trauma Care
Surgeon

Secretary, Indian Medical Association, Coimbatore branch, 2007-8
Trustee, IMA Masonic Mahaveers Rotary Midtown Blood Bank
District Chairman, Polio Corrective Surgery, RID 3200, 2005-6, 2007-8