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 Global health experts hope the deal will help address two looming
problems in the HIV epidemic - the rising threat of resistance
developing to standard AIDS drugs, and the need for more investment
in manufacturing capacity.
Bill Gates' charitable foundation will guarantee minimum sales
volumes of the new combination pills using dolutegravir, a so-called
integrase inhibitor that avoids the drug resistance that often
develops with older treatments.
In return the drugmakers, India-based Mylan Laboratories <MYL.O> and
Aurobindo Pharma <ARBN.NS>, will agree the maximum price of about
$75 per patient for a year's supply - less than the list price for
one day's supply of a dolutegravir combination in the United States.
The agreement, which will make the treatment available to 92 poor
countries, starting in Africa, will be formally announced during the
United Nations General Assembly in New York on Thursday.
"We need to make that guarantee because (of) the fixed costs of
everybody gearing up to make high volume," Gates told Reuters in a
telephone interview. "That just wasn't going to happen unless we put
forward a very substantial volume guarantee."
The Bill & Melinda Gates Foundation's pledge is a central plank of a
new partnership - the largest of its kind in global health - that
also includes the governments of South Africa and Kenya, the Clinton
Health Access Initiative, and American, British and U.N. agencies.
Under the deal, Mylan and Aurobindo will ramp up availability of a
new fixed-dose combination of tenofovir disoproxil fumarate,
lamivudine and dolutegravir (TLD).
Health ministries and other public sector purchasers will be able to
buy TLD from next year at the capped price. The agreement could
potentially save them more than $1 billion in drug bills over the
next six years, the partners estimate.
As well as improving treatment, the drug combination should also
reduce the need for more expensive second- and third-line drugs.
TREATMENT AND RESISTANCE
Around 37 million people around the world are infected with HIV,
according to the United Nations AIDS agency UNAIDS. Just over half
of them - about 19.5 million patients - get antiretroviral therapy
medicines to keep their disease in check.
That represents remarkable progress in the past 20 years, driven by
the availability of a first wave of cheap generic drugs from Indian
companies. But rising levels of drug resistance are now a growing
concern, while low prices have cut the incentive for investment in
generic drug-making capacity.
In six out of 11 countries surveyed recently in Africa, Asia and
Latin America, researchers found that more than 10 percent of HIV
patients starting antiretroviral drugs had a strain of HIV resistant
to the most widely-used medicines.
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Once the 10 percent threshold is reached, best practice calls for
switching to different drug regimens.
Dolutegravir is already being used on a limited basis as a single
drug in Kenya, Nigeria, and Uganda.
The drug was originally developed by ViiV Healthcare, the HIV
business majority-owned by GlaxoSmithKline <GSK.L>. ViiV has offered
licensing deals to generic companies to sell low-cost versions of
the medicine in poor countries.
Clinical trials have shown that treatment regimens including
dolutegravir work faster, have fewer side effects and demonstrate
greater potency against drug resistance than standard HIV drugs used
in Africa and other poor countries.
The TLD combination pill developed by Mylan and Aurobindo has
already received tentative approval from the U.S. Food and Drug
Administration under the President's Emergency Plan for AIDS Relief
program.
In Western markets, makers of patented AIDS drugs, such as GSK and
arch-rival Gilead Sciences <GILD.O>, notch up billions of dollars of
highly profitable sales each year.
But the picture is very different for low-price generic companies in
India, which have very low margins.
"The market is always on the edge where these guys don't make enough
money to stay in the business," said Gates.
With the HIV-positive population still growing - there were an
estimated 1.8 million new cases of infection in 2016 - the number of
patients needing treatment is steadily increasing.
Industry experts like Johnson & Johnson <JNJ.N> Chief Scientific
Officer Paul Stoffels question the feasibility of maintaining
lifelong treatment for a patient population that could reach 50
million.
"The people who are infected today will need therapy for the next 30
to 50 years, so the science of treatment has to evolve and the
science of prevention has to evolve as well to stop the pool of
patients growing," he told Reuters in a recent interview.
(Editing by Pravin Char)
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