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NY N006212

February 12, 2007



TARIFF NO.: 2933.79.8500; 3004.90.9115

Mr. Wyatt S. Holyk
Livingston International Inc.
1140 West Pender Street
Vancouver, Canada V6E 4H5

RE: The tariff classification of ISK247, imported in bulk and capsule forms, from Switzerland

Dear Mr. Holyk:

In your letter dated January 31, 2007, on behalf of your client, Isotechnika Inc., you requested a tariff classification ruling.

The subject product, ISK247, is an investigational new drug (IND) currently being evaluated in phase II clinical trials to determine its safety and efficacy in preventing kidney transplant rejection

See: http://clinicaltrials.gov/ct/show/NCT00270634?order=1., and in phase III clinical trials to determine its safety and efficacy as a treatment for plaque psoriasis See: http://clinical trials.gov/ct/show/NCT00408187?order=2.. An article published in the scientific journal Transplant International See: http://www.ncbi.nlm.nih.gov/entrez/query.fcg?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15827754&itool=iconabs. defines ISK247 as “a novel cyclosporine analog,” describing it as “a more potent immunosuppressant than cyclosporine in vitro,” and concluding that “ISA247 suppresses diverse immune functions more potently than cyclosporine in vitro.” Another article found on the website of Bioscienceworld See: http://www.bioscienceworld.ca/Building BlockbusterPotential. describes ISA247 as a “high-potency cyclosporine analogue.” Finally, we note that the phase III clinical trial alluded to above (see footnote 2) states that “ISA247 represents the possibility of a calcineurin inhibitor which is not only as efficacious as ciclosporin A, but also has an improved toxicity profile.”

You assert in your letter that ISK247 is entitled to duty-free status, pursuant to G.N. 3(c)(i) and G.N. 13, HTSUS, since it belongs to the class of compounds known as cyclosporins, the major component being cyclosporine (names previously used: cyclosporin A; cyclosporin) The International Nonproprietary Name (INN) for cyclosporine is “ciclosporin,” which is listed in Table 1 of the Pharmaceutical Appendix to the Tariff Schedule.. We, however, disagree. Notwithstanding that ISK247 is a synthetically produced cyclosporine analog, there is no evidence that it is also known as “cyclosporine,” per se, or “ciclosporin,” per se. Accordingly, pursuant to the language of G.N. 13, HTSUS, we find that, at the present time, ISK247, imported in bulk form, is not eligible for special tariff treatment.

The applicable subheading for ISK247 imported in bulk form will be 2933.79.8500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Lactams: Other Lactams: Other: Other.” The rate of duty will be 6.5 percent ad valorem.

Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, dated May 24, 2000), the applicable subheading for ISK247 imported put up in capsules will be 3004.90.9115, HTSUS, which provides for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.” The rate of duty will be free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.


Robert B. Swierupski

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