[Ip-health] [Request] Information on R&D of Sprycel

[seo bokyeong]

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*[Request] Information on R&D of Sprycel *


Korean NGOs including IPLeft and Korean Pharmacists for Democratic Society
are struggling together with leukemia patients to fight against the Korean
government and Bristol-Myers Squibb (BMS) to lower the price of Sprycel
which is an oral inhibitor of multiple tyrosine kinases. Sprycel is
essential for the treatment of adults with chronic, accelerated, or myeloid
or lymphoid blast phase chronic myeloid leukemia with resistance to prior
therapy such as Gleevec (imatinib meslylate).

Sprycel was approved by Korea Food & Drug Administration on January, 2007.
And on October 2007, Drug Reimburesement Assessment Committee (DRAC) under
the Health Insurance Review & Assessment Service (HIRA) decided that Sprycel
had to be reimbursed by the government. On December 2007, National Health
Insurance Corporation started a price negotiation with BMS, and BMS insisted
that the price of Sprycel should be decided at the 69,135 Koran won (about
70 USD) per pill comparing the price of Sprycel with that of Gleevec. BMS
claimed that the price of 2 pills of Sprycel should be same as that of six
pills of Gleevec (current Korea price of Glevec is 23,045 won per pill).

But, the price of Gleevec was determined based on the A7 average price (USA,
U.K., France, Germany, Etaly, Swiss, Japan) in 2003 and has not been changed
since. A7 price was not a right startpoint for Korea, since the Korea are
differ from A7 countries in many soci-economic and public health related
aspects.

The negotiations between BMS and NHIC were broken off on 14, January, 2008.
Since Sprycel is essential drug for patients, the Ministry of Health,
Welfare, and Family Affairs (MHWF) took control over the negotiation, and on
May 2008 they finally decided the price of Sprycel  at the 55,000 won (about
55USD)

The expense which a patient in Korea has to pay to take Sprycel is over
about 40 million won (about 40,000 USD) a year, which most Koreans can't
afford. (Moreover, Norvatis is willing to request that the price of
Tasigna(nilotinib) per pill has to be higher than Sprycel.) While 90% of the
expense is covered by national health insurance, the finances of national
health insurance are getting worse due to high expenses for drug.

We are demanding the Korean government and BMS to provide transparent
standards for deciding the price of drug. However, BMS just said that "It is
natual that the price of drug is high because of astronomical expenses for
developing new drugs" without publicizing its expenses for research,
development and production. Korean government has no standards or datas for
the decision of the drug's price, therefore all it can do is to ask BMS to
offer 10% or 20% lower price than the original suggestion.

Moreover, Korean government has no alternative plans to 'the suspension of
supply' by phamaceutial companies. Actually, Roche had not supplied yet
Fuzeon requesting average price of A7 though Fuzeon had been included as a
drug covered by national health insurance on 2004.

We are searching for information on R&D and production costs of Sprycel.
Such information might include researches done in the universities or public
lab, goverment fund or grant, tax credit, or market prospect of Sprycel.

Following is the information we have found already.

-Sawyers of UCLA's Jonsson. Comprehensive Cancer Center contributed to the
design of Sprycel (dasatinib).
-clinical trial phase I: In a study published in the June 15, 2006, issue of
the New England Journal of Medicine (NEJM), Howard Hughes Medical Institute
(HHMI) researchers at the University of California, Los Angeles, and
colleagues at M.D. Anderson Cancer Center and Bristol-Myers Squibb in
Princeton, NJ, report data from phase I human clinical trials of the
compound, dasatinib (BMS-354825).

-clinical trial:
http://www.cancer.gov/search/ResultsClinicalTrialsAdvanced.aspx?protocolsearchid=4505339

-FDA approval: 28th June 2006.
Sprycel is considered an orphan drug for each of these indications. Under
the Orphan Drug program, sponsors of medications intended for fewer than
200,000 patients in the United States can receive 7-year marketing
exclusivity, tax credit for the product-associated clinical research,
research design assistance by the FDA, and grants of up to $200,000 per
year.

*If you have any information about Sprycel, please let us know. Any
information will be a great help for our fight against BMS. We hope your
support and solidarity for our struggle to improve the access to medicine in
Korea and worldwide.*

Best Regards,