E-DRUG: Launch of new non-patented Low-Cost Antimalaria medicine
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This week the Drugs for Neglected Diseases Initiative (DNDi), will launch
an important new antimalarial product ASAQ. ASAQ is an important
improvement over existing malaria therapies and will not be patent
protected. Competitors can produce the product immediately.
The launch of ASAQ is proof that non-patent based models of financing
medical R&D exist and can deliver much needed essential medicines.
Development of the new formulation, including clinical trial cost only 6.4
Million Euros from Public and Private Resources (see
http://www.actwithasaq.org/en/asaq4.htm). The intiative to develop ASAQ
was launched by MSF in 2002 and transferred to DNDi in 2003.
DNDi was established in 2003 by seven organisations from around the world:
five public sector institutions (from Kenya, Brazil, India, Malaysia and
France), Médecins sans Frontières (MSF).
There will be a briefing on Friday in DC to discuss this project.
Buddhi
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Dr Buddhima Lokuge
U.S Manager
Campaign for Access to Essential Medicines
Doctors Without Borders/Médecins Sans Frontières (MSF)
http://www.doctorswithoutborders.org/news/access/index.cfm
Buddhima Lokuge <Buddhima.Lokuge@newyork.msf.org>
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http://www.nytimes.com/2007/03/01/health/01malaria.html?pagewanted=print
The New York Times
March 1, 2007
Low-Cost Antimalaria Pill Available
By DONALD G. McNEIL Jr.
A new, cheap, easy-to-take pill to treat malaria is being introduced
today, the first product of an innovative partnership between an
international drug company and a medical charity.
The medicine, called ASAQ, is a pill combining artemisinin, invented in
China using sweet wormwood and hailed as a miracle malaria drug, with
amodiaquine, an older drug that still works in many malarial areas.
A treatment will cost less than $1 for adults and less than 50 cents for
children. Adults with malaria will take only two pills a day for three
days, and the pill will come in three smaller once-a-day sizes for
infants, toddlers and youngsters.
In Africa, malaria kills 3,000 babies and children each day, but
combination drugs like this are not available for children under 11
pounds, and they require taking a larger number of pills each day, as many
as 24 for some adult versions.
'This is a good thing,' said Dr. Arata Kochi, chief of the World Health
Organization's global malaria program, who has publicly demanded that drug
companies stop making pills that contain artemisinin alone because they
will lead to resistant strains of malaria. 'They're responding to the kind
of drug profile we've been promoting.'?
Doctors like to treat diseases with multidrug cocktails because it cuts
down the chance that resistance to any one drug will develop.
Adm. R. Timothy Ziemer, coordinator of President Bush's $1.2 billion
Malaria Initiative, said the program would be willing to buy the new pill,
assuming it meets international safety standards and is requested by
countries the initiative supports.
Sanofi-Aventis, the world's fourth-largest drug company, based in Paris,
will sell the pill at cost to international health agencies like the
W.H.O., Unicef and the Global Fund for AIDS, Tuberculosis and Malaria.
The rollout of the drug is the result of a two-year partnership between
Sanofi and the Drugs for Neglected Diseases Initiative, a campaign started
by the medical charity Doctors Without Borders to find new drugs for
tropical diseases.
Doctors Without Borders, better known by its French name, Medecins Sans
Frontieres, has long been one of the harshest critics of the
pharmaceutical industry, charging that it spent billions on drugs like
Viagra, Ambien and Prozac for rich countries and almost nothing on
diseases killing millions of poor people.
But, recognizing that new drugs would have to come from the industry's
major players, Doctors Without Borders founded the initiative in 2003 and
began seeking partnerships. This is the first to come to fruition.
'This was not a love wedding, it was a reasonable wedding,' said Dr.
Robert Sebbag, Sanofi's vice president for access to medicines.'But
reasonableness is often more important for a long marriage. They've seen
we are not nasty people working against poor countries and seeking only
profits.'
In an unusual move, Sanofi has decided not to seek any patents so the
pills can be freely copied by generic companies like those in India. The
drugs themselves are too old to patent, but the one-pill formulation could
have been.
Sanofi will also produce a branded version, called Coarsucam, for the
private market, to be sold at three or four times the public price. It
will be sold only in Africa, Indonesia and the Philippines, the company
said, not in the United States or Europe.
In another innovation, Sanofi will meet with pharmacists' organizations in
poor countries and give them incentives to sell Coarsucam at two different
prices - at less than $1 to very poor customers and $3 to $4 to wealthier
ones.
It will leave it to the pharmacists to estimate which of their customers
lived on less than the cutoff income, which is about $40 a month, Dr.
Sebbag said.
'Even in these countries, you always have some people who can pay,' he
said.
The company has already experimented with the idea in six African
countries, from Mali to Kenya to Madagascar, when selling its previous
version of the drug combination, which was separate pills of each drug in
a blister pack.
'It is not a perfect system,' Dr. Sebbag admitted. 'But we had about a
50-50 division, and we have not seen any cannibalization of the private
market by the public.'?
The company will package the cheaper Coarsucam differently and have its
sales staff check to make sure that pharmacies are not selling the cheap
product at the high price.
Neither version, at either price, will bring Sanofi much profit, 'but in
terms of symbolism, it means a lot,' ? Dr. Sebbag said.
One reason for keeping the price low, he said, was to remove the incentive
for counterfeiters to produce fakes, which is a serious problem in Asia
and a growing one across Africa. Fake malaria drugs - most offered as
artemisinin - may be involved in up to 200,000 deaths from malaria each
year.
ASAQ and Coarsucam will not replace a rival drug, Coartem from Novartis, a
Swiss pharmaceutical company, that has been sold cheaply to the W.H.O.
since 2001. Coartem combines another form of artemisinin with
lumefantrine, another Chinese drug, and in East Africa, it works better
than ASAQ because resistance to amodiaquine is common.
'But ASAQ is much more easy to use,' said Dr. Bernard Pecoul, director of
the Drugs for Neglected Diseases Initiative. 'And it is nearly half as
expensive.'
Novartis used to sell Coartem to public health agencies at close to $3 per
adult treatment; its price has dropped recently to about $1.70 as Indian
companies announced the development of generic versions. Dr. Kochi said he
expected prices to fall further with the competition from ASAQ.
'It is the chain reaction of market competition,' he said. 'This is exactly
what we wanted.'