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Wednesday, 08/03/2005 5:58:20 PM

Wednesday, August 03, 2005 5:58:20 PM

Post# of 253567
Price and availability of plasma-derived antithrombin products:

[This is reposted, with minor editing, from Norman Klein’s #21602-04 on the Yahoo GTCB board. The tables below list the plasma-derived antithrombin products that GTCB’s ATryn will compete against if approved in the EU later this year. Note that GTCB is seeking marketing approval via the EU’s central regulatory process rather than on a country-by-country basis and hence ATryn can be sold in any EU country once approved. (Reimbursement is on a country-by-country basis, however.) In the tables below, the lack of a product name to the right of the population figure for a country means that no AT product is available in that country.]


EUROPEAN UNION (approx. 450 million people):
Country, Population (million), Product(s) available
Austria 8.2 Atenativ, Thrombhibin, Antimbin P, Kybernin
Belgium 10.4
Cyprus 0.8
Czech Rep. 10.2 Kybernin
Denmark 5.4 Atenativ
Estonia 1.4
Finland 5.2 Atenativ
France 59.6 Aclotine
Germany 82.5 Atenativ, ATIII, Kybernin
Greece 11.0 Atenativ, Kybernin
Hungary 10 Atenativ, Kybernin
Ireland 4
Italy 57.3 Atenativ, Anbin, Kybernin
Latvia 2.4
Lithuania 3.7
Luxembourg 0.4
Malta 0.4
Netherlands 16.2 Atenativ
Poland 38.8
Portugal 10.4
Slovakia 5.4
Slovenia 2
Spain 40.7 Atenativ, Anbin, Kybernin
Sweden 8.9 Atenativ
United Kingdom 58.8 Kybernin


Non-EU EUROPE:
Country, Population, Product(s) available
Albania 3.1
Andorra 0.1
Belarus 10.2
Bosnia 4
Bulgaria 8.2
Croatia 4.5
Iceland 0.3
Liechtenstein n/a
Macedonia 2
Moldova 4.4
Monaco n/a
Norway 4.5 Atenativ
Romania 22.3
Russia 146.9
San Marino n/a
Serbia-Montenegro 10.6
Switzerland 7.4 Atenativ, Kybernin
Turkey 66.6
Ukraine 50.50
Vatican City n/a


REST OF WORLD:
Country, Population, Product(s) available
Australia 18.9 Thrombotrol
Brazil 170.1 Kybernin
Canada 31.1 Thrombate III
Hong Kong 7 Thrombate III
Japan 126.7 Neuart
New Zealand 3.9 Thrombotrol
USA 278.4 Thrombate III

--

NOTES:

1. The average is based on the formula : units required (IU) = [desired AT-III level (%) baseline AT-III level (%)]/1.4 x body weight (kg). where the average body weight (man and woman) has been set to 70 kg and the desired level 120% and the baseline level at 50 %.
The baseline is normally varying between the 40 and 60 % of the normal level. Thus, if a 70 kg individual has a base-line AT-III level of 50%, in order to increase plasma AT-III to 120%, the initial THROMBATE III dose would be [(120-50) x 70]/1.4 = 3500 IU total.

2. AT-III deficiency is found in approximately 1 in 2,000 to 5,000 persons.

3. Market prices found so far are in the range of EUR350-440 [approx. $285-325M] per 1000 units. An average of 3500 units will be needed (see above). This will give a average of EUR1225-1540 [$1,000-1,250] per treatment. It is expected that compared with the plasma the recombinant version, ATryn can be sold with a small premium as it is safer then plasma.

--
References for market prices:

http://www.sante.gouv.fr/htm/dossiers/retrocession/decret2.pdf (France)
http://www.giofil.it/offline/SObttlth.htm (Italy)
http://www.hidoctor.com.br/tabela/?session=&Description=k&Global=&Offset=120&tpl =win (brazil)
http://www.iespana.es/inspeccion-uvmi1/inde1021.htm (Spain used to be 390 Euro, now 310 Euro, possibly this is the subsidized vendor price)
http://www.oddb.org/en/generika/search/state_id/-873720638/search_query/B01AB02 (Switzerland)

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