- Most of the research and development of d4T was paid for with U.S. government funds.
- Bristol-Myers Squibb sells d4T for a price 50 times higher than foreign generic competitors
can.
- The vast majority of People With Aids worldwide could never afford d4T at these prices.
- Bristol-Myers Squibb has already made billions in sales.
- Yale University, which owns the key patents, have been asked to make their IPR available to
third parties.
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Government Expenditure on Research and Development
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- Stavudine (d4T) was initially synthesized under an NCI grant by Dr. Jerome Horowitz
of the Michigan Cancer Foundation (Karmanos Cancer Institute) in 1966.
- Dr. Tai-Shun Lin (Yale) and Dr. William Prusoff (Yale) first discovered d4T's
capability to treat HIV/AIDS. Yale used significant government funding under
Grant CA-28852 from the NIH.
- Bristol-Myers Squibb's role in the development of d4T was the sponsoring of trial AI455-019,
which involved 822 patients, and the median analysis time was six months. Even if the trial
cost-per-patient was $10,000 - far above the average clinical trial cost - BMS would have
spent under $10 million. This is under two percent of d4T sales in 1999 alone.
- OnOctober 5, 1992, the FDA annouced that d4T would be made available for
"expanded invetigational use" under the agency's "parallel track" policy. Here
is the
FDA press release.
- For more information on the R&D expenditures on d4T and other HIV/AIDS drugs, see the
CPT Page on the government's
role in the development of HIV/AIDS drugs.
- Bristol-Myers Squib sells stavudine for $5.00 per 40 mg tablet. Cipla, a generic
manufacturer in India, has agreed to supply generic stavudine for $0.10 per 40 mg
tablet - a 98% price reduction. At this price, furthermore, Cipla still reports
profits on the drug.
- For more information on pricing of HIV/AIDS drugs, see
CPT's page on drug pricing.
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Access in Developing Nations
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- The standard dosage requirement is two 40mg capsules a day (30mg for adults under 130 pounds).
At $5.00 per pill, this comes to US$3,650 each year. Contrast this to the
GDP per people living with HIV/AIDS in the developing
nations where the majority of the HIV/AIDS cases are.
- March 18, 2002. Letter from the Kenya Coalition for Access to
Essential Medicines to Bristol-Myers Squibb regarding a
Supply crisis of ddI and d4T in Kenya.
- In the first quarter of 2000, BMS reported $151 million in sales of Stavudine. This was the
same level of sales as in the first quarter of 1999. (Source:
SEC form 10-Q, which is the most recent SEC filing to date.)
- In 1999, BMS reported $605 million in sales of Stavudine. For 1998 and 1997, the sales were
$551 million and $398 million, respectively. (Stavudine has been on the market since 1994.)
(Source:
SEC Form 10-K).
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Yale Asked to Permit South Africa to Import d4T from Generic Producers
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Medicines San Frontieres has asked Yale University to permit South Africa to import
generic d4T into South Africa. As stated above, Yale holds key patent rights on
the drug, and has licensed it to Bristol-Myers Squibb, which pays Yale roughly $40
million annually in royalties. A group of 600 Yale researchers has petitioned the
school, asking it "to permit a generic version of its patented anti-retroviral
drug d4T to be imported and distributed in South Africa."
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