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Viewing cable 07BANGKOK1524, ABBOTT LABS HALTS NEW DRUG REGISTRATIONS

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Reference ID Created Released Classification Origin
07BANGKOK1524 2007-03-14 23:23 2011-08-26 00:00 UNCLASSIFIED Embassy Bangkok
VZCZCXRO5674
RR RUEHCHI RUEHDT RUEHHM RUEHNH
DE RUEHBK #1524 0732323
ZNR UUUUU ZZH
R 142323Z MAR 07
FM AMEMBASSY BANGKOK
TO RUEHC/SECSTATE WASHDC 5544
RUCNASE/ASEAN MEMBER COLLECTIVE
RUEHGV/USMISSION GENEVA 1793
RUCPDOC/USDOC WASHINGTON DC
RUEAUSA/DEPT OF HHS WASHINGTON DC
UNCLAS BANGKOK 001524 
 
SIPDIS 
 
SIPDIS 
 
STATE PASS USTR FOR B. WEISEL, C. WILSON 
STATE PASS USPTO 
HHS/OHGA FOR AMAR BHAT 
USDOC FOR JKELLY 
 
E.O. 12958:N/A 
TAGS: ECON ETRD KIPR TH
SUBJECT:  ABBOTT LABS HALTS NEW DRUG REGISTRATIONS 
 
1. Abbott Labs, the recent target of a compulsory license on their 
patented antiretroviral Kaletra, confirmed to Embassy that the 
company had withdrawn applications for registration of seven new 
pharmaceutical products in Thailand, and had no plans to introduce 
new products until its intellectual property was properly respected. 
 The seven drugs include Aluvia, a new heat-stable version of 
Kaletra.  Although the two drugs are identical in effect, the new 
version is considered ideal for tropical environments such as 
Thailand.  Other drug applications pulled include treatments for 
hypertension, kidney disease, auto-immune disease and congestive 
heart failure.  The applications had been on file with the Thai FDA 
for up to ten months awaiting approval. 
 
2. Abbott said they had notified the FDA's Drug Control Division 
(DCD), but RTG officials interviewed by press said they were unaware 
of Abbott's actions (Embassy's calls to FDA officials were not 
returned today).  The DCD's Senior Pharmacist Dr. Suchart 
Chongprasert told a Wall Street Journal reporter that he was 
surprised that Abbott would choose to unilaterally restrict its 
sales in Thailand and was waiting to see the actual documentation 
withdrawing the applications.  Asked if the RTG would respond with 
further CLs, Dr. Suchart said the process of identifying drugs to 
license was lengthy and no more CLs were in the pipeline. 
 
3.  Matichon newspaper quoted Dr. Siriwat Tiptaradol, Secretary 
General of the Thai FDA, that the Ministry of Public Health planned 
to invite relevant parties, especially the three companies whose 
patents were broken, to meet on March 26 to negotiate.  However, 
none of the three had yet to receive an invitation. 
 
4. Comment:  Abbott's actions will certainly be controversial. 
However, the action may strengthen the hand of Abbott and the rest 
of industry in future dealings with the RTG.  Abbott's move puts the 
RTG on notice that there are visible consequences for its actions, 
rather than solely a vague weakening of the investment environment. 
Whether this focuses the minds of RTG officials at upcoming 
negotiations remains to be seen.  End Comment. 
BOYCE