Abbott To File In Thailand For Kaletra Pediatric AIDS Indication
In an apparent change of position, Abbott will file for approval of a pediatric formulation of its antiretroviral protease inhibitor Kaletra (lopinavir/ritonavir) tablets in Thailand, the firm announced July 27.
The action marks a turning point in the big pharma's policy toward the Southeast Asian country. Earlier this year, Abbott said it would no longer launch new products in Thailand because in January, Thailand's Ministry of Public Health issued a compulsory license for Kaletra.
A compulsory license essentially breaks a firm's patent in that country and allows a more affordable generic versions to be sold there.
In response, Abbott said it would no longer launch new products in Thailand because the country is "ignoring the patent system."
However, Abbott announced in April that it would cut the price of the HIV therapy in more than 40 developing countries, including Thailand, to about $1,000 per patient annually ("The Pink Sheet" DAILY, April 11, 2007). In Africa and countries deemed "least developed," Abbott's current price for the drug is $500 per patient per year.
The firm has since said it is "working in cooperation with the Thai government to have [Kaletra] approved by Thailand's Food and Drug Administration so that patients in Thailand may begin to use this new medical innovation."
"Abbott welcomes Thai government assurances that it will not issue additional compulsory licenses," the firm said in a May 25 announcement.
[Editor's note: For an in-depth look at the Thailand compulsory license dispute, download PharmAsia News' complimentary report Pharma IP Rights at Risk in Asia.]
Kaletra also is marketed as Aluvia in developing countries. It requires no refrigeration and can be taken with or without a meal, according to the company.
Earlier this month, Abbott said it had applied to the FDA and European Medicines Agency for approval of a lower-strength tablet to treat the pediatric AIDS population.
The lower-strength tablet contains 100 mg of lopinavir and 25 mg of ritonavir, half the dose of the adult-strength version. The price of the lower-strength tablet will be half that of the full-strength tablet, Abbott said.
WHO recommends lopinavir/ritonavir for the treatment of children who no longer respond to first-line HIV medicines. HHS recommends the drug combination for the initial treatment of children with HIV.
Thailand has a population of 65 million, an adult HIV/AIDS prevalence of 1.5 percent and annual death rate from AIDS of 58,000, according to the Central Intelligence Agency's World Factbook.
- Pamela Taulbee
This article is reprinted from "The Pink Sheet" DAILY – July 31, 2007
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