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[e-drug] Abbott reduces ARV prices

E-DRUG: Abbott reduces ARV prices
[several messages in one; first the Abbott press release, then Jamie Love's
comments, and finally the Wall Street Journal article. The latter contains a
table with the current status of company price reduction offers.

Would be interesting to know the price of Abbott's test kits, as they are
widely used. Before ARV treatment, everybody needs to be tested!

Copied as fair use. Thanks to Pharm-Policy. NN]



Abbott Park, Illinois, March 27, 2001 ? Abbott Laboratories today
announced that it will offer its two antiretroviral medications for the
treatment of HIV infection, KaletraTM (lopinavir/ritonavir) and Norvir®
(ritonavir), in Africa at no profit to Abbott.

Additionally, Abbott will make its DetermineTM HIV-1/2 rapid test
available in Africa, also at no profit to Abbott. Determine is an
easy-to-use, rapid, qualitative immunoassay test that can detect the
presence of HIV-1/2 antibodies using a small amount of whole blood,
human serum, or plasma, without instrumentation. The Determine HIV-1/2
test was specifically developed for use in settings where access to
laboratory equipment is limited.  

"AIDS has taken an unprecedented toll on the health, economic, and
social structures of Africa," said Miles D. White, Abbott chairman and
chief executive officer. "Abbott has taken this action to give people
most affected by this disease a better opportunity to access care. It is
our sincere hope that this action, along with those of other
pharmaceutical companies, will lead governments and other sources of
international funding to help make a difference for millions of people
who need AIDS care. The next step in the global response is to develop
the infrastructure necessary to deliver effective treatment."

Abbott will continue its ongoing dialogue with representatives from the
World Health Organization and UNAIDS to optimize access to
antiretroviral therapies and use of diagnostic tools.

Abbott will make these products available to qualified entities that can
provide the drugs to patients in Africa as part of a sound and
sustainable therapeutic program. Qualified entities include government
and non-governmental organizations, United Nations system organizations,
and other national and international health institutions. The products
for Africa must be used in the country where they are sold and cannot be

Abbott's initiative is one of a number of steps the company has taken to
address multiple aspects of the HIV pandemic. Abbott and the company's
philanthropic arm, the Abbott Laboratories Fund, established Step
Forward?for the world's children, in June 2000. By providing funding,
medical supplies and community support, Step Forward was developed to
address the needs of AIDS orphans and vulnerable children, who,
according to the U.S. Agency for International Development (USAID), will
number 40 million by 2010. Step Forward is currently active in Tanzania,
Burkina Faso, India, and Romania. Additionally, Abbott is working
directly with the Tanzanian government on a pilot initiative to increase
access to treatment and care for the country's growing AIDS population,
which is estimated at more than 1.3 million.

About Norvir 
Norvir is not a cure for HIV infection. People treated with Norvir may
continue to acquire illnesses associated with advanced HIV infection,
including opportunistic infections. Norvir may not be right for
everyone, including people with liver disease, hepatitis or hemophilia.
Redistribution/accumulation of body fat has been observed in patients
receiving protease inhibitors. Elevated blood sugar levels have been
reported in patients taking protease inhibitors. Allergic reactions
ranging from mild to severe have been reported. Pancreatitis has been
observed in patients receiving Norvir therapy, including those who
developed high triglycerides. The risk of myopathy, including
rhabdomyolysis, may be increased when Norvir is used in combination with
HMG CoA reductase inhibitors (statin class of lipid-lowering drugs).
Common adverse reactions include fatigue, vomiting, diarrhea, loss of
appetite, abdominal pain, taste disturbance, tingling sensation or
numbness in the hands, feet, or around the lips, headache and dizziness.
Norvir should not be used with certain medications including some
non-sedating antihistamines, sedative hypnotics, anti-arrhythmics or
ergot alkaloid preparations. Patients should talk with their physician
or pharmacist or refer to the Norvir full prescribing information.

About Kaletra
Kaletra should not be used with certain medications. Taking certain
other drugs with Kaletra could create the potential for serious side
effects that could be life threatening. Patients should always talk to
their physician or healthcare provider before starting new medicines.

Kaletra should not be taken if a patient has had an allergic reaction to
Kaletra or any of its ingredients. Cross-resistance to other protease
inhibitors has been observed. Increased bleeding in patients with
hemophilia, and diabetes and high blood sugar have occurred in some
patients when taking protease inhibitors. Changes in body fat have been
seen in some patients receiving antiretroviral therapy. Some patients
receiving Kaletra have had large increases in triglycerides and
cholesterol. Pancreatitis and abnormal liver function have been reported
in patients receiving Kaletra.   

Kaletra is not a cure for HIV infection. People treated with Kaletra may
continue to acquire illnesses associated with advanced HIV infection,
including opportunistic infections. Kaletra has not been shown to reduce
the risk of passing HIV to others through sexual contact or blood
contamination. Patients should continue to practice safe sex and should
not use or share dirty needles. In adults, the most commonly reported,
Kaletra-related side effects of moderate severity are: abdominal pain,
abnormal stools, diarrhea, feeling weak/tired, headache, nausea and

[Comments from Jamie Love <love@cptech.lorg, 1.202.387.8030>  ]

1.  Both Norvir and Kaletra were developed developed with federal
taxpayer support, and the US government has rights to patents on both

2.  The US government could, and has been asked to repeatedly, give the
WHO the right to use these patents in poor countries.

3.  Pricing for both products is very high in the USA, and consumers
here are asked to pay top dollar for drugs invented on government

4.  The Abbott offer is limited in many important ways.  It is limited
to Africa, and of course, there are important health care problems
outside of Africa too.  Within Africa, the offer will be limited, and
not, for example, available in the private sector.  Because the price is
still so high, few governments will buy even at the lower price.   

5.  In South Africa, there are important opportunities for treatment in
the private sector.  If Abbott will not make this available in the
private sector, and the government does not buy in the public sector,
the offer will not be that important.  

6.  We are asking once again for DHHS, this time Tommy Thompson, to give
the WHO the rights to use US government rights in patents developed with
federal funds, in poor countries.  Certainly in Africa, but also in
other developing countries.  

Jamie Love <love@cptech.lorg, 1.202.387.8030>  


Thanks to Drop for this item on Kaletra 

According to the  Orange Book unleashed site, and the FDA CDER site, all
but two of the patents for Kaletra, (a combination of lopinavir and
ritonavir), include this in their patent legend:

"This invention was made with Government support under contract number
Al27220 awarded by the National Institute of Allergy and Infectious
Diseases. The Government has certain rights in this invention." 


[WSJ article; copied as fair use; NN]


March 27, 2001  
Abbott to Cut Prices on AIDS Drugs
Distributed in Sub-Saharan Africa

In the latest response to the growing public outcry over international
AIDS-drug pricing, Abbott Laboratories is planning to sell its two AIDS
drugs and its HIV diagnostic test at "no profit" in sub-Saharan Africa.

Abbott's decision comes amid a striking round of price cuts for AIDS
drugs in Africa by several major drug companies and two generic-drug
makers. At the same time, however, several other companies, most notably
Pfizer Inc. and Roche Holding Ltd., have yet to reduce the prices of
their AIDS-related medicines as sharply.

Abbott is expected to announce Tuesday that it will sell each of its two
protease-inhibitor drugs, Norvir and Kaletra at a price that will
provide the company "no profit," confirmed a company spokesman. The
spokesman said the company was still determining the exact price for the
drugs, but a source close to the company said each drug will likely be
less than $1,000 a year per patient. That would be about 70% less than
the already-discounted price Abbott began charging for Norvir in Africa
several years ago. But it is still out of the reach of most poor
Africans and is much pricier than other companies' discounted
AIDS-related drugs.

The drug sells in the U.S. for about $7,100 at wholesale. Kaletra, which
was just approved for use in the U.S. late last year, sells at about
$6,500 in the U.S. Last year, Norvir world-wide sales were $200 million;
Kaletra is expected to generate that much this year.

As part of its offer, Abbott, based in Abbott Park, Ill., confirmed it
will also sell its easy-to-use HIV diagnostic kit called Determine at no
profit, according to a company spokesman. Currently, Abbott charges
about $1.20 per test in Africa.

An Abbott spokesman said the price it will be charging for the drugs and
the test will vary among purchasers. That is because Abbott's price will
include its manufacturing costs and other costs related to getting the
drugs to certain locales. The price doesn't account for marketing or
research costs, the spokesman said.

The offer comes two weeks after Bristol-Myers Squibb Co. said it will
sell two of its AIDS drugs below cost in Africa and three weeks after
Merck & Co. said it will sell two of its AIDS drugs "at cost" in Africa
and other poor nations. Two Indian generic-drug makers, Cipla Ltd. and
Hetero Drugs Ltd., have also discounted AIDS medicines.

Abbott's offer differs from the others because it includes a procedure
to facilitate distribution of the drugs. The company has hired Axios
International, a Dublin, Ireland, consulting firm, to set up an office
in Kampala, Uganda, to handle requests from governments, medical
centers, nonprofit groups and employers from anywhere in Africa, to
determine whether they can use the drugs properly.

"Abbott believes it needed to add a feature to get the drugs to people
who need them," said Joseph Saba, chief executive of Axios, which runs
several company-sponsored drug-access programs in Africa. "Still, these
drugs aren't going to be used unless wealthy nations and other donor
groups start providing the money to help pay for them." Dr. Saba said
Axios and Abbott are hoping to enlist Merck, Bristol-Myers and other
drug makers in the project.


Price Cuts and Policies Below are various ways drug companies 
are introducing less expensive AIDS drugs to Africa.  

Company Region  Price  Purchase Condition/ Distribution Methods 

Pfizer South Africa  Free donation of Diflucan  Only available at 
government hospitals or clinics  

Merck/Bristol Sub-Sahara and other developing nations-a  
At or just below cost Available to any purchaser  

Cipla Sub-Sahara  $350 to $600 a year-b  Available to 
any purchaser  

Abbott Sub-Sahara  At 'no profit'  Available to any 

Roche Sub-Sahara  15% to 50% discount under certain 
conditions  Only via UNAIDS  

Hetero Sub-Sahara  $347  Available to governments and 
int'l. organizations   

a-Only Merck is currently offering discounts outside Africa.
b-Cipla's $600 offer is for a three-drug combination to countries; its
$350 offer is only to Doctors without Borders, a private organization.

Sources: The companies; Unaids; WSJ research


Indeed, 10 months after five big drug makers announced an initiative to
make AIDS drugs affordable in sub-Saharan Africa, companies are still
struggling over how best to increase access to their life-saving
treatments. Abbott was not part of the five-company initiative, so this
new offer is its first significant price concession since 1998. About 25
million people in sub-Saharan Africa are infected with HIV, the virus
that causes AIDS.

Roche, the Swiss drug-maker that was part of the initiative last year,
offered its first price reduction only last month, in a letter to
Unaids, the United Nations agency that runs AIDS programs. Roche offered
a rebate worth 50% off the existing price in Africa of its protease drug
Fortovase, and worth a 15% reduction off its price for its protease drug
Viracept. According to a Roche spokeswoman, when the rebates are figured
in, Viracept's price will be $3,467 a year and Fortovase's $2,482.

Ben Plumley, the Unaids official in Geneva handling the drug access,
said the Roche offer won't have much effect unless it is followed by
aggressive outreach to individual countries. Merck, Bristol-Myers,
Boehringer-Ingelheim GmbH and GlaxoSmithKline PLC have reached
agreements with Senegal, Rwanda, Uganda and the Ivory Coast to sell
cheaper AIDS drugs. Roche hasn't been part of those agreements, but the
company says it is in "active negotiations" with Uganda and the Ivory
Coast to supply medicines at the new prices.

In Uganda, Sowedi Muyingo, who buys AIDS drugs for Medical Access Ltd.,
a nonprofit drug distributor, said of the Roche rebate, "It is really
not much of an offer because nobody here can afford even the new price."

Under pressure from AIDS activists last year, Pfizer, based in New York,
agreed to spend $50 million on a two-year giveaway program of its
anti-fungal drug Diflucan, but only in South Africa. Pfizer said it has
no plans to reduce the drug's price, which sells for about $20 a day in
Uganda. Robert Huber, a Pfizer spokesman, did confirm that Pfizer is
talking with several other African nations about donating Diflucan there
as well.

Mr. Huber said Pfizer will supply people in South Africa who need the
drug as long as necessary. But he said the company will re-evaluate the
program in two years; that is when Pfizer's patent expires for Diflucan,
which had about $1 billion in world-wide sales last year. The Indian
company Cipla sells a generic version of the drug for about $3.50 a day
in Uganda.

Although Bristol-Myers said it won't use its patent for its drug Zerit
to block South Africa from buying generic versions, the company is in a
patent battle in Thailand over its other AIDS drug, Videx. Tido von
Schoen-Angerer, a Bangkok pediatrician with the advocacy group Doctors
Without Borders, said 11 HIV-infected people, among others, intend to
file a lawsuit in Bangkok's Intellectual Property Court seeking to
revoke Bristol-Myers's Videx patent.

The original patent on the drug is held by the U.S. National Institutes
of Health. The Thai group is targeting the company's patent on a
reformulated tablet that includes the active medicine plus an antacid

GlaxoSmithKline, the United Kingdom-based pharmaceutical company that
has cut the price of its AIDS medicine, Combivir, to $2 a day in Africa,
said it has no plans to reduce the price of its AIDS drug Ziagen or its
new triple combination therapy, Trizivir. A company spokeswoman, Nancy
Pekarek, says GlaxoSmithKline is worried that rare but dangerous
hypersensitivity side effects associated with Ziagen and Trizivir might
be more difficult to deal with in Africa.

Meanwhile, student activists at the University of Minnesota are hoping
to push administrators at the school, which holds the patent for Ziagen,
to discuss with GlaxoSmithKline the possibility of price reductions and
allowing generic competition. "We are at the beginning stages of a
campaign," said Amanda Swarr, graduate student.

-- Mark Schoofs contributed to this article.

Write to Rachel Zimmerman at rachel.zimmerman@wsj.com and Michael
Waldholz at mike.waldholz@wsj.com
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