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
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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.
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