[Ip-health] Times of India: Firms ready with cheaper AIDS drugs

[Sheila.SHETTLE@geneva.msf.org]

Generic versions of the new once-a-day FDC of TDF/FTC/EFV are being=0D
developed in India and their approximate market launch in India (to start=
=0D
with) could be expected within the coming months (see Times of India=0D
article below).  This new combination is crucial as an improved first-line=
=0D
and alternative to the FDC containing d4T/3TC/NVP, which is commonly used=
=0D
in the developing world today.  WHO recommends combinations containing TDF,=
=0D
as they have fewer side effects than those containing d4T.=0D
=0D
Generic companies have already applied for marketing approval in India and=
=0D
therefore the generic equivalent of this new once-a-day FDC could be=0D
available within months of US FDA approval of Gilead/BMS=E2=80=99s version =
of the=0D
new FDC. The generic price of US$ 2,160 per patient per year as reported by=
=0D
the Times of India is much more affordable than the US market price of=0D
nearly US$14,000. The price is still very high compared to current=0D
first-line FDC prices, but  when generic competition exists, prices can be=
=0D
expected to fall over time.=0D
=0D
However, Gilead=E2=80=99s patent application on TDF is being examined in In=
dia.  In=0D
May 2006, MSF supported PLWHA groups and the lawyers that represent them in=
=0D
filing a pre-grant opposition to this patent application.  If the patent is=
=0D
granted on TDF, for which there was no generic production pre-2005, any=0D
generic production could be effectively blocked by the patent holder until=
=0D
the patent expires, which could be as late as 2018.  Also, the development=
=0D
of FDCs containing TDF, such as the new once-a-day combination of=0D
TDF/FTC/EFV, could be blocked until the patent term is up.=0D
=0D
Because many developing countries depend on Indian producers for=0D
affordable, quality medicines, a patent in India could dramatically affect=
=0D
access to medicines in the rest of the world, and it is critical to make=0D
sure that patents are not granted erroneously.=0D
=0D
=0D
Times of India=0D
Firms ready with cheaper AIDS drugs=0D
Rupali Mukherjee=0D
=0D
 13 Jul, 2006 2250hrs ISTTIMES NEWS NETWORK=0D
NEW DELHI: There is good news for HIV patients. The first three-in-one=0D
combination single pill to treat AIDS will soon be launched by Indian drug=
=0D
companies at around Rs 1 lakh (per annum, per patient) - or around Rs 274=
=0D
per day - which will be 80-85% cheaper than the global price of nearly Rs 7=
=0D
lakh per patient per year ($15,000).=0D
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The single once-a-day pill will make the treatment cheaper and easier=0D
as against struggling with dozens of pills in a day.=0D
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The single pill, which is a combination of three drugs, also got US=0D
FDA nod on Wednesday. The pill, Atripla, which contains Bristol-Myers=0D
Squibb=0D
Co's drug Sustiva and Gilead Inc's medicines Viread and Emtriva, is the=0D
latest step in making it easier for AIDS patients to keep HIV in check.=0D
=0D
Sources said that major Indian companies including Cipla and Hetero=0D
Drugs are already working on it, and may launch it close to the worldwide=
=0D
launch by foreign companies.=0D
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Cipla joint MD Amar Lula said, "We are ready with the formulation for=0D
the three-in-one single pill, and are applying to the Drug Controller of=0D
India for approval". The company's single once-a-day pill will be branded=
=0D
as=0D
Viraday.=0D
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He added that foreign companies have started following the example set=0D
by Cipla in launching fixed dose combinations to treat HIV.=0D
=0D
In 2001, Cipla launched the first fixed-dose combination, Triomune=0D
that combined three antiretroviral drugs in one pill (twice a day), and=0D
offered it at $350 (Rs 15,000) per patient, per year as against global=0D
price=0D
of $10,439 (Rs 5 lakh).=0D
=0D
This also became one of the frequently prescribed treatments in=0D
developing countries, making the treatment simpler and cheaper.=0D
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Hyderabad-based Hetero Drugs is also working on the fixed dose single=0D
pill and will launch it in a few months. The company's director-marketing,=
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M=0D
Srinivas Reddy said: "We are waiting for the licence to initiate studies on=
=0D
the drug, and will launch it substantially cheaper than the global price".=
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Experts say that with more competition coming in, prices of these=0D
drugs would go down. Recently, Aurobindo Pharma got FDA approval to produce=
=0D
a generic version of a three-combination drug.=0D
=0D
They added that the single dose pill is a new and better combination,=0D
and may soon become the preferred treatment for AIDS, because of its=0D
simplicity and lack of side-effects. The fixed-dose combination is based on=
=0D
the recent protocol by WHO for developing countries.=0D
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+++++++++++++++++++++=0D
Sheila Shettle=0D
Communications Officer=0D
M=C3=A9decins Sans Fronti=C3=A8res=0D
Campaign for Access to Essential Medicines=0D
Rue de Lausanne 78=0D
1211 Geneva=0D
Switzerland=0D
+ 41.22.849.8403=0D
sheila.shettle@geneva.msf.org=0D
www.accessmed-msf.org=0D
=0D