Russia through the prism of the world biopharmaceutical market

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Biotechnology Journal Table 2. Continued 8 © 2007 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim BTJ 07/07 | TD | DOI 10.1002/biot.200700091 Registered trademark in RF Manufacturer Indication Remarks Hormones Biotechnol. J. 2007, 2 Puregon (INN-follitropin-β) Organon Stimulating ovaries to produce eggs Zadaxin (peptide hormone SciClone, USA Hepatitis B,C, with pegylated Chemically synthesized thymosin-α1) www.zadaxin.ru. IFN-α Blood clothing factors Recombinate rec. factor VIII Baxter Int. Inc. Antihemophilic factor Kogenate FS –”- Bayer NovoSeven rec. factor VIIa Novo Nordisk MAbs Avastin (bevacizumab) Genentech/Roche Tumors, anti-neoplastic mAb Simulect (basiliximab) Novartis Transplantations, anti-CD25 mAb Resoclon anti-Rhesus 0(D) mAb Hematolog. RF Registered in 1999, in 2004 extended Zenapax (daclizumab) Roche Transplantations, multiple sclerosis, binds CD25 of high-affinity human IL2 receptor Remicade (infliximab) Centocor/Shering Plough Artritis, Crohn’s disease, ulcerative colitis blocks TNF-α MabThera (rituximab) Genentech/Roche B cell non-Hodgkin’s lymphoma, CD20 Herceprin (trastuzumab) Disseminated breast cancer with HER2 hyperexpression Orthoclone (muromonab) Ortho-Pharmaceutical, US, Cilag, Swiss Transplantation, anti-CD3 of T cells mAb Reopro (abciximab) Centocor/Lilly Anti-aggregant thrombocyte therapy Enzymes Metalyse (tenecteplase, rec. tissue Boehringer Ingelheim, Myocardial infarction, brain insult plasminogen activator) Germany Rec. pro-urokinase: Russian Cardiology Research Purolase Center, RF Hemase Technogen, RF Ophthalmology Pulmozyme (Dornase α, rec. α-DNase) Genentech/Roche Mucoviscidosis Erisod (rec. superoxide dismutase) GNC HPB, Ophthalmology, solar and Investors needed Resbio, RF thermal burns, cosmetics Cerezyme (rec. imiglucerase) Genzyme, UK Gaucher’s disease Recombinant vaccines against Hepatitis B (contain rHBs-Ag) Engerix B GlaxoSmithKline First rec. vaccine, since 1987 Euvac Aventis Pasteur HB Vac II Merck Sharp & Dohme Biovac-B, Wockhardt, India Shanvac-B Shanta, India HB rec. DNA-vaccine Ever Biotech, Cuba Rec. yeast HB vaccine Microgen, subsidiary Virion, RF Combiotech Combiotech, RF, http://www.combiotech.com GALLEY PROOF
to-use rHI forms Rinsulin ® and tries to market them outside of the federal DLO purchase. Among the aforementioned manufacturers, those of the governmental ownership, i.e., GNC HPB (St. Petersburg), IBCH RAN [Russian abbreviation of the Russian Academy of Science (RAS) (Moscow)], GNC Vector (Vector-Medica; Novosibirsk region) are using renovated industrial facilities created at the end of Soviet era owing to heavy state funding. In addition, a modern biotech complex with the mixed form of ownership, A/S “National Biotechnologies”, was built and equipped in 2003. In spite of an extended list of domestic manufacturers and some preferences for them declared by DLO, the structure of DLO purchases in January–June 2006 [29] shows an absolute domination of the key multinational players. The leader, Janssen-Cilag has shown a unique sales growth of 664% in 2006 in the DLO sector, thus increasing its total share to 10.33%. The Top 10 list in the DLO segment also includes multinational giants Roche, Novartis, Sanofi–Aventis and Novo Nordisk. Blockbuster biopharmaceuticals dominate over corresponding Russian biogenerics in almost all DLO top positions. Indeed, the Federal DLO Top 20 sales list includes Betaferon, Eprex, Mabtera, Lantus, and Humulin NPH, occupying 5th, 7th, 8th, 13th, and 16th position, respectively, with the total market share near 6% (5.1% excluding Humulin NPH). Regional Top 20 lists also include Herceptin, Novo- Seven, and Recombinate, as well as Avastin, Remicade, and Cerezyme in the nomination “Novel Medicines”, which contribute an additional 1.3%. Taken together, recombinant therapeutic proteins (excluding insulins) constituted 6.4% of the DLO market (i.e., $ 83.2 million of the $ 1.3 billion total DLO purchase), while pharmaceuticals for diabetes mellitus treatment (of which more than 90% of medicines in Russia are represented by insulins) contributed 7.7% or $ 100.1 million in the first half of 2006. The expenses for the annual Epo-α cure supplied by the Western manufacturers per patient with kidney insufficiency are estimated to be near $ 7000; treatment of one patient suffering from hepatitis C with pegylated rIFN-α may take annually $ 4000; and for each of 100–150 thousand patients suffering from multiple sclerosis the annual cure by rIFN-β is estimated as $ 16–32 thousand. Current evaluations show that near 300 thousand patients suffering from servere diseases (hemophilia, mucoviscidosis, multiple sclerosis) require 40–50% of the total DLO budget, since every prescription for them may cost more than $ 400 [30]. In other words, if these categories of patients depend on imported recombinant biopharmaceuticals, they require almost the same budgetary provision as the rest 14 million preferential patients included in the DLO supply program. For this reason, according to Russian mass media, independent expert forecasts have estimated costs of DLO 2006 to be $ 2.5 billion, albeit with the Federal Ministry of Healthcare providing only $ 1.4 billion. BTJ 07/07 | TD | DOI 10.1002/biot.200700091 Biotechnol. J. 2007, 2 www.biotechnology-journal.com Currently, federal indebtedness in the framework of DLO has reached $ 1.5 billion, from which only $ 0.6 billion is planned to be reimbursed by the Ministry. The Ministry suggests that the rest should be covered by the manufacturers participating in the DLO program and reimbursed later by regional insurance companies. Because of this, patients suffering from diabetes mellitus, multiple sclerosis, epilepsy, blood diseases and various forms of cancer receive three- to fourfold lower-than-required dosages of necessary medications, and in some regions (e.g., Altay) corresponding groups of medications were not prescribed at all. This demonstrates the urgency of substituting expensive blockbuster drugs by cheap domestic biogenerics. However, the practice of state purchase is accompanied by always delayed payment, which slows down small domestic manufacturers [31]. The Ufa subsidiary of A/S Pharmstandard developed and launched production of ready-to-use rHI in 2005, with the maximum annual capacity of 7.7 billion IU insulin. This would in principle fully cover the domestic needs (ca. 7.4 billion IU calculated on the assumption of average 0.7% population (145 million) suffering from insulin-dependent diabetes mellitus [32]. This minimal calculated demand in rHI corresponds to ca. 280 kg API rHI, assuming that 1 IU is equivalent to 0.0347 mg pure insulin, and preparation of 10 ml of the ready-to-use solution (100 IU/ml) requires 36–38 mg API. However, production of Pharmatsndard is now limited by only 5% of the existing capacities, since it depends on imported API rHI. Budgetary provisions covering all the demands of patients are estimated to reach $ 240 million per annum, whereas real domestic insulin sales by the end of 2006 constituted $ 158 million [33], of which domestic manufacturers of rHI have shared only 1.9%, namely: 0.4% Biosulin (A/S Pharmstandard) and 1.5% Insuran (pilot facility of IBCH RAS). The later was the only domestic recombinant drug mentioned in DLO Top 10 sales lists [34], namely, in the nomination “Novel Medicines” in the largest federal district Moscow constituting 30% of the total DLO market. 4 Russian recombinant insulin (Insuran): The path from bench to market Traditionally, all the patients suffering from diabetes mellitus were supplied in the former Soviet Union and later in Russia received cost-free rHI with the expenses being covered from the budget sources. This demand has formed the guaranteed national rHI market, which has shown 1.6-fold growth since 2000. Since the first recombinant insulin appearance on the US market, the ability to produce rHI was considered an indicator of the national biotech development level. The recommendation of WHO to have domestic production of rHI in all the countries with population exceeding 50 mil- GALLEY PROOF © 2007 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim 9
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Russia through the prism of the world biopharmaceutical market

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