[Ip-health] Launch of new non-patented Low-Cost Antimalaria medicine

[Buddhima Lokuge]

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This week the Drugs for Neglected Diseases Initiative (DNDi), will launch=
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an important new antimalarial product ASAQ. ASAQ is an important=0D
improvement over existing malaria therapies and will not be patent=0D
protected. Competitors can produce the product immediately.=0D
=0D
The launch of ASAQ is proof that non-patent based models of financing=0D
medical R&D exist and can deliver much needed essential medicines.=0D
=0D
Development of the new formulation, including clinical trial cost only 6.4=
=0D
Million Euros from Public and Private Resources (see=0D
http://www.actwithasaq.org/en/asaq4.htm). The intiative to develop ASAQ=0D
was launched by MSF in 2002 and transferred to DNDi in 2003.=0D
=0D
DNDi was established in 2003 by seven organisations from around the world:=
=0D
five public sector institutions (from Kenya, Brazil, India, Malaysia and=0D
France), M=C3=A9decins sans Fronti=C3=A8res (MSF).=0D
=0D
There will be a briefing on Friday in DC to discuss this project.=0D
=0D
Buddhi=0D
=0D
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Dr Buddhima Lokuge=0D
U.S Manager=0D
Campaign for Access to Essential Medicines=0D
Doctors Without Borders/M=C3=A9decins Sans Fronti=C3=A8res (MSF)=0D
http://www.doctorswithoutborders.org/news/access/index.cfm=0D
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http://www.nytimes.com/2007/03/01/health/01malaria.html?pagewanted=3Dprint=
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=0D
The New York Times=0D
=0D
March 1, 2007=0D
Low-Cost Antimalaria Pill Available=0D
By DONALD G. McNEIL Jr.=0D
=0D
A new, cheap, easy-to-take pill to treat malaria is being introduced=0D
today, the first product of an innovative partnership between an=0D
international drug company and a medical charity.=0D
=0D
The medicine, called ASAQ, is a pill combining artemisinin, invented in=0D
China using sweet wormwood and hailed as a miracle malaria drug, with=0D
amodiaquine, an older drug that still works in many malarial areas.=0D
=0D
A treatment will cost less than $1 for adults and less than 50 cents for=0D
children. Adults with malaria will take only two pills a day for three=0D
days, and the pill will come in three smaller once-a-day sizes for=0D
infants, toddlers and youngsters.=0D
=0D
In Africa, malaria kills 3,000 babies and children each day, but=0D
combination drugs like this are not available for children under 11=0D
pounds, and they require taking a larger number of pills each day, as many=
=0D
as 24 for some adult versions.=0D
=0D
=E2=80=9CThis is a good thing,=E2=80=9D said Dr. Arata Kochi, chief of the =
World Health=0D
Organization=E2=80=99s global malaria program, who has publicly demanded th=
at drug=0D
companies stop making pills that contain artemisinin alone because they=0D
will lead to resistant strains of malaria. =E2=80=9CThey=E2=80=99re respond=
ing to the kind=0D
of drug profile we=E2=80=99ve been promoting.=E2=80=9D=0D
=0D
Doctors like to treat diseases with multidrug cocktails because it cuts=0D
down the chance that resistance to any one drug will develop.=0D
=0D
Adm. R. Timothy Ziemer, coordinator of President Bush=E2=80=99s $1.2 billio=
n=0D
Malaria Initiative, said the program would be willing to buy the new pill,=
=0D
assuming it meets international safety standards and is requested by=0D
countries the initiative supports.=0D
=0D
Sanofi-Aventis, the world=E2=80=99s fourth-largest drug company, based in P=
aris,=0D
will sell the pill at cost to international health agencies like the=0D
W.H.O., Unicef and the Global Fund for AIDS, Tuberculosis and Malaria.=0D
=0D
The rollout of the drug is the result of a two-year partnership between=0D
Sanofi and the Drugs for Neglected Diseases Initiative, a campaign started=
=0D
by the medical charity Doctors Without Borders to find new drugs for=0D
tropical diseases.=0D
=0D
Doctors Without Borders, better known by its French name, M=C3=A9decins San=
s=0D
Fronti=C3=A8res, has long been one of the harshest critics of the=0D
pharmaceutical industry, charging that it spent billions on drugs like=0D
Viagra, Ambien and Prozac for rich countries and almost nothing on=0D
diseases killing millions of poor people.=0D
=0D
But, recognizing that new drugs would have to come from the industry=E2=80=
=99s=0D
major players, Doctors Without Borders founded the initiative in 2003 and=
=0D
began seeking partnerships. This is the first to come to fruition.=0D
=0D
=E2=80=9CThis was not a love wedding, it was a reasonable wedding,=E2=80=9D=
 said Dr.=0D
Robert Sebbag, Sanofi=E2=80=99s vice president for access to medicines. =E2=
=80=9CBut=0D
reasonableness is often more important for a long marriage. They=E2=80=99ve=
 seen=0D
we are not nasty people working against poor countries and seeking only=0D
profits.=E2=80=9D=0D
=0D
In an unusual move, Sanofi has decided not to seek any patents so the=0D
pills can be freely copied by generic companies like those in India. The=0D
drugs themselves are too old to patent, but the one-pill formulation could=
=0D
have been.=0D
=0D
Sanofi will also produce a branded version, called Coarsucam, for the=0D
private market, to be sold at three or four times the public price. It=0D
will be sold only in Africa, Indonesia and the Philippines, the company=0D
said, not in the United States or Europe.=0D
=0D
In another innovation, Sanofi will meet with pharmacists=E2=80=99 organizat=
ions in=0D
poor countries and give them incentives to sell Coarsucam at two different=
=0D
prices =E2=80=94 at less than $1 to very poor customers and $3 to $4 to wea=
lthier=0D
ones.=0D
=0D
It will leave it to the pharmacists to estimate which of their customers=0D
lived on less than the cutoff income, which is about $40 a month, Dr.=0D
Sebbag said.=0D
=0D
=E2=80=9CEven in these countries, you always have some people who can pay,=
=E2=80=9D he=0D
said.=0D
=0D
The company has already experimented with the idea in six African=0D
countries, from Mali to Kenya to Madagascar, when selling its previous=0D
version of the drug combination, which was separate pills of each drug in=
=0D
a blister pack.=0D
=0D
=E2=80=9CIt=E2=80=99s not a perfect system,=E2=80=9D Dr. Sebbag admitted. =
=E2=80=9CBut we had about a=0D
50-50 division, and we have not seen any cannibalization of the private=0D
market by the public.=E2=80=9D=0D
=0D
The company will package the cheaper Coarsucam differently and have its=0D
sales staff check to make sure that pharmacies are not selling the cheap=0D
product at the high price.=0D
=0D
Neither version, at either price, will bring Sanofi much profit, =E2=80=9Cb=
ut in=0D
terms of symbolism, it means a lot,=E2=80=9D Dr. Sebbag said.=0D
=0D
One reason for keeping the price low, he said, was to remove the incentive=
=0D
for counterfeiters to produce fakes, which is a serious problem in Asia=0D
and a growing one across Africa. Fake malaria drugs =E2=80=94 most offered =
as=0D
artemisinin =E2=80=94 may be involved in up to 200,000 deaths from malaria =
each=0D
year.=0D
=0D
ASAQ and Coarsucam will not replace a rival drug, Coartem from Novartis, a=
=0D
Swiss pharmaceutical company, that has been sold cheaply to the W.H.O.=0D
since 2001. Coartem combines another form of artemisinin with=0D
lumefantrine, another Chinese drug, and in East Africa, it works better=0D
than ASAQ because resistance to amodiaquine is common.=0D
=0D
=E2=80=9CBut ASAQ is much more easy to use,=E2=80=9D said Dr. Bernard Pecou=
l, director of=0D
the Drugs for Neglected Diseases Initiative. =E2=80=9CAnd it is nearly half=
 as=0D
expensive.=E2=80=9D=0D
=0D
Novartis used to sell Coartem to public health agencies at close to $3 per=
=0D
adult treatment; its price has dropped recently to about $1.70 as Indian=0D
companies announced the development of generic versions. Dr. Kochi said he=
=0D
expected prices to fall further with the competition from ASAQ.=0D
=0D
=E2=80=9CIt=E2=80=99s the chain reaction of market competition,=E2=80=9D he=
 said. =E2=80=9CThis is exactly=0D
what we wanted.=E2=80=9D=0D
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