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| Brand Name | Procrit | | Generic Name | | | Epoetin alfa | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Mechanism | Recombinant protein which stimulates erythropoeisis (red blood cell production). Naturally produced in the kidney. 165AA. 30.4kD. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| IP | European patents have expired (2004). US August 2013? Generic biologics are non-substitutable globally (must be marketed by generic company). | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Approved | 6/1/1989 making it JNJ's oldest drug that is still marketed. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Market | 20m patients with chronic kidney disease, 67% are anemic (US). | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Safety | Death and tumor progression with higher doses. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Administration | Sub-cutaneous injection, usually given qw versus Aranesp's q2w/q3w. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Competition | Aranesp (AMGN). Suing AMGN for anti-competitive bundling. Discounting/Contracting cycle? Roche's CERA. Biogenerics from Teva, Stada. Affymax's Hematide. Shire's Dynepo. Merck EPO. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Will Roche enter the market in the US? When will the first biogeneric be approved? How will changes to guidelines affect the competition between Procrit and Aranesp? | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reimbursement | Medicare rolling ASP+6%. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Guidelines | CKD patients should have a hemoglobin less than 10g/dL for initiation. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Usage | Procrit is 50% oncology and 50% is CKD. 25% of oncology is used in "curative" patients (Stage 1-3). | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Model | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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| Procrit/Eprex | Q100 | Q200 | Q300 | Q400 | Q101 | Q201 | Q301 | Q401 | Q102 | Q202 | Q302 | Q402 | Q103 | Q203 | Q303 | Q403 | Q104 | Q204 | Q304 | Q404 | Q105 | Q205 | Q305 | Q405 | Q106 | Q206 | Q306 | Q406 | Q107 | Q207 | Q307 | Q407 |
| Domestic | 387 | 411 | 458 | 554 | 514 | 554 | 742 | 525 | 691 | 764 | 776 | 803 | 723 | 707 | 703 | 671 | 688 | 582 | 613 | 578 | 565 | 566 | 575 | 540 | 527 | 524 | 522 | 491 | 530 | 449 | 380 | 331 |
| International | 215 | 230 | 233 | 221 | 254 | 276 | 286 | 278 | 300 | 322 | 320 | 293 | 274 | 308 | 302 | 296 | 289 | 293 | 274 | 272 | 271 | 280 | 269 | 258 | 259 | 284 | 276 | 297 | 287 | 309 | 302 | 297 |
| Worldwide | 602 | 641 | 691 | 775 | 768 | 830 | 1028 | 803 | 991 | 1086 | 1096 | 1096 | 997 | 1015 | 1005 | 967 | 977 | 875 | 887 | 850 | 836 | 846 | 844 | 798 | 786 | 808 | 798 | 788 | 817 | 758 | 682 | 628 |
| y/y | | | | | 0.27574750830564776 | 0.29485179407176276 | 0.48769898697539804 | 0.03612903225806452 | 0.29036458333333326 | 0.308433734939759 | 0.06614785992217898 | 0.36488169364881684 | 0.006054490413723412 | -0.06537753222836096 | -0.083029197080292 | -0.11770072992700731 | -0.02006018054162484 | -0.13793103448275867 | -0.11741293532338304 | -0.1209927611168563 | -0.14431934493346976 | -0.03314285714285714 | -0.04847801578354005 | -0.06117647058823528 | -0.05980861244019142 | -0.044917257683215084 | -0.0545023696682464 | -0.01253132832080206 | 0.0394402035623409 | -0.061881188118811936 | -0.14536340852130325 | -0.20304568527918787 |
| Aranesp (AMGN) | | | | | | | | | 39 | 56 | 114 | 207 | 255 | 348 | 438 | 503 | 543 | 617 | 608 | 705 | | | | | | | | | | | | |
| y/y | | | | | | | | | | | | | 5.538461538461538 | 5.214285714285714 | 2.8421052631578947 | 1.4299516908212562 | 1.1294117647058823 | 0.7729885057471264 | 0.38812785388127846 | 0.40159045725646125 | | | | | | | | | | | | |
| Epogen (AMGN) | | | | | 503 | 518 | 517 | 609 | 512 | 570 | 558 | 620 | 547 | 611 | 626 | 651 | 590 | 633 | 681 | 697 | | | | | | | | | | | | |
| y/y | | | | | | | | | 0.017892644135188762 | 0.10038610038610041 | 0.079303675048356 | 0.01806239737274229 | 0.068359375 | 0.07192982456140351 | 0.12186379928315416 | 0.050000000000000044 | 0.07861060329067637 | 0.036006546644844484 | 0.08785942492012788 | 0.07066052227342556 | | | | | | | | | | | | |
| Total Market | | | | | 1271 | 1348 | 1545 | 1412 | 1542 | 1712 | 1768 | 1923 | 1799 | 1974 | 2069 | 2121 | 2110 | 2125 | 2176 | 2252 | | | | | | | | | | | | |
| y/y | | | | | | | | | 0.21321793863099914 | 0.27002967359050456 | 0.14433656957928798 | 0.36189801699716706 | 0.16666666666666674 | 0.15303738317756999 | 0.1702488687782806 | 0.10296411856474252 | 0.17287381878821573 | 0.0764944275582573 | 0.05171580473658777 | 0.06176331918906186 | | | | | | | | | | | | |
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| Procrit/Eprex | 1997 | 1998 | 1999 | 2000 | 2001 | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 | 2008E | 2009E | 2010E | 2011E | 2012E | 2013E | | | | | | | | | | | | | | | |
| Domestic | 500 | 752 | 1240 | 1810 | 2335.3 | 3034 | 2804 | 2461 | 2246 | 2064 | 1690 | 1250 | 1000 | 900 | 810 | 729 | 656.1 | | | | | | | | | | | | | | | |
| International | 635 | 743 | 854 | 899 | 1093.9 | 1234.5 | 1180 | 1128 | 1078 | 1116 | 1195 | 1100 | 990 | 891 | 801.9 | 721.71 | 649.5390000000001 | | | | | | | | | | | | | | | |
| Worldwide | 1135 | 1495 | 2094 | 2709 | 3429.2000000000003 | 4268.5 | 3984 | 3589 | 3324 | 3180 | 2885 | 2350 | 1990 | 1791 | 1611.9 | 1450.71 | 1305.6390000000001 | | | | | | | | | | | | | | | |
| y/y | | 0.31718061674008813 | 0.4006688963210703 | 0.2936962750716332 | 0.26585455887781473 | 0.24475096232357396 | -0.06665104837765023 | -0.09914658634538154 | -0.07383672332125946 | -0.04332129963898912 | -0.09276729559748431 | -0.1854419410745234 | -0.15319148936170213 | -0.09999999999999998 | -0.09999999999999998 | -0.09999999999999998 | -0.09999999999999998 | | | | | | | | | | | | | | | |
| Aranesp (AMGN) | | | | | 42 | 415.6 | 1543.8 | 2472.9 | 3273 | 3838.32499275 | 4479.32526653925 | 3583.4602132314003 | 2866.7681705851205 | 2723.4297620558646 | 2587.2582739530712 | 2457.8953602554175 | 2335.0005922426467 | | | | | | | | | | | | | | | |
| | | | | | | 8.895238095238096 | 2.7146294513955724 | 0.6018266614846484 | 0.3235472522139997 | 0.1727237985792851 | 0.167 | -0.2 | -0.19999999999999996 | -0.04999999999999993 | -0.050000000000000044 | -0.050000000000000044 | -0.04999999999999993 | | | | | | | | | | | | | | | |
| Epogen (AMGN) | | | | 1962.4 | 2108.1 | 2260 | 2434.6 | 2600.6 | 2455 | 2460.74 | 2485.3473999999997 | 2361.0800299999996 | 2313.8584293999997 | 2313.8584293999997 | 2336.9970136939996 | 2360.3669838309397 | 2383.9706536692493 | | | | | | | | | | | | | | | |
| | | | | | 0.07424582144313074 | 0.07205540534130273 | 0.07725663716814157 | 0.06818368520496176 | -0.05598707990463736 | 0.002338085539714818 | 0.01 | -0.05 | -0.02 | 0 | 0.01 | 0.01 | 0.01 | | | | | | | | | | | | | | | |
| Total Market | | | | 4671.4 | 5579.3 | 6944.1 | 7962.4 | 8662.5 | 9052 | 9479.06499275 | 9849.672666539249 | 8294.5402432314 | 7170.62659998512 | 6828.288191455864 | 6536.1552876470705 | 6268.972344086357 | 6024.610245911896 | | | | | | | | | | | | | | | |
| | | | | | 0.19435287065975948 | 0.24461850052874023 | 0.1466424734666838 | 0.08792575102984035 | 0.04496392496392487 | 0.047179075646266 | 0.039097492640118636 | -0.1578867111585197 | -0.13550041476541486 | -0.04774177036773419 | -0.04278274372987578 | -0.040877692129755894 | -0.0389796101756571 | | | | | | | | | | | | | | | |
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| JNJ Sales | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Procrit/Eprex % of Total Sales | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Gross Margin | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | | | | | | | | | | | | |
| Gross Profit | 897.3000000000001 | 913.5 | 904.5 | 870.3000000000001 | 879.3000000000001 | 787.5 | 798.3000000000001 | 765 | 752.4 | 761.4 | 759.6 | 718.2 | 707.4 | 727.2 | 718.2 | 709.2 | 735.3000000000001 | 682.2 | 613.8000000000001 | 565.2 | | | | | | | | | | | | |
| FTE | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | 700 | | | | | | | | | | | | |
| Cost/FTE | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | 0.075 | | | | | | | | | | | | |
| FTE Expenses | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | | | | | | | | | | | | |
| Operating Expenses | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | 52.5 | | | | | | | | | | | | |
| Operating Income | 844.8000000000001 | 861 | 852 | 817.8000000000001 | 826.8000000000001 | 735 | 745.8000000000001 | 712.5 | 699.9 | 708.9 | 707.1 | 665.7 | 654.9 | 674.7 | 665.7 | 656.7 | 682.8000000000001 | 629.7 | 561.3000000000001 | 512.7 | | | | | | | | | | | | |
| Operating Margin | 0.8473420260782347 | 0.8482758620689655 | 0.8477611940298507 | 0.8457083764219235 | 0.8462640736949847 | 0.84 | 0.8408117249154454 | 0.8382352941176471 | 0.8372009569377991 | 0.8379432624113475 | 0.8377962085308057 | 0.8342105263157895 | 0.833206106870229 | 0.8350247524752475 | 0.8342105263157895 | 0.8333756345177665 | 0.8357405140758875 | 0.8307387862796834 | 0.8230205278592376 | 0.8164012738853504 | | | | | | | | | | | | |
| JNJ Operating Profit | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Procrit/Eprex % of Total OP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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| | | | | | 2006 | 2007 | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | | | | | | | | | | | | | | | |
| | | | Competitive Entries | | | 0 | 0 | 0 | 0 | 0 | -0.05 | -0.1 | -0.1 | -0.1 | -0.1 | -0.1 | -0.1 | | | | | | | | | | | | | | | |
| | | | Pricing | | | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | | | | | | | | | | | | | | | |
| | | | Unit Growth - Pre-Dialysis | | | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | | | | | | | | | | | | | | | |
| | | | Unit Growth - Cancer | | | -0.2 | -0.2 | -0.1 | -0.05 | -0.05 | -0.05 | -0.05 | -0.05 | -0.05 | -0.05 | -0.05 | -0.05 | | | | | | | | | | | | | | | |
| | | | Market Share | | | -0.05 | -0.05 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | -0.02 | | | | | | | | | | | | | | | |
| | | | Patent Expiry Penalty | | | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | | | | | | | | | | | | | | | |
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| | | | Pre Dialysis | 0.4 | 802.4000000000001 | 732.0937120000001 | 667.9476609545601 | 628.6669949091444 | 591.6963462725274 | 556.8998675409325 | 497.942215124056 | 421.7933064033365 | 357.28963707633216 | 302.65033328923244 | 256.3668652402434 | 217.16139836627562 | 183.95151376603653 | | | | | | | | | | | | | | | |
| | | | Cancer | 0.6 | 1203.6 | 896.4412799999998 | 667.6694653439998 | 577.1067790647397 | 526.5406830830872 | 480.40518843134697 | 416.3964815299427 | 341.9206396364602 | 280.76539787236214 | 230.54826033970718 | 189.31285959186783 | 155.45274015098553 | 127.64877395306056 | | | | | | | | | | | | | | | |
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| | | | Domestic Forecast | | 2006 | 1628.5349919999999 | 1335.61712629856 | 1205.773773973884 | 1118.2370293556146 | 1037.3050559722794 | 914.3386966539988 | 763.7139460397966 | 638.0550349486944 | 533.1985936289396 | 445.6797248321112 | 372.61413851726115 | 311.6002877190971 | | | | | | | | | | | | | | | |
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| | | | | International | 2064 | 2218.8 | 2053.6800000000003 | 1902.2340000000002 | 1763.2365 | 1635.577455 | 1518.25108425 | 1410.3457818375 | 1311.035019365625 | 1219.5691423553437 | 1135.2679717997764 | 1057.5141311157677 | 985.7470266753612 | | | | | | | | | | | | | | | |
| | | | Pre-dialysis | 0.25 | 516 | 567.6 | 539.22 | 512.259 | 486.64605 | 462.3137475 | 439.198060125 | 417.23815711874994 | 396.37624926281245 | 376.5574367996718 | 357.72956495968816 | 339.84308671170373 | 322.8509323761185 | | | | | | | | | | | | | | | |
| | | | Dialysis | 0.25 | 516 | 567.6 | 539.22 | 512.259 | 486.64605 | 462.3137475 | 439.198060125 | 417.23815711874994 | 396.37624926281245 | 376.5574367996718 | 357.72956495968816 | 339.84308671170373 | 322.8509323761185 | | | | | | | | | | | | | | | |
| | | | Cancer | 0.5 | 1032 | 1083.6000000000001 | 975.2400000000001 | 877.7160000000001 | 789.9444000000001 | 710.9499600000001 | 639.8549640000001 | 575.8694676000001 | 518.2825208400001 | 466.4542687560001 | 419.8088418804001 | 377.8279576923601 | 340.0451619231241 | | | | | | | | | | | | | | | |
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| | | | | Total Procrit (WW) | 4070 | 3847.334992 | 3389.29712629856 | 3108.0077739738845 | 2881.473529355615 | 2672.8825109722793 | 2432.589780903999 | 2174.0597278772966 | 1949.0900543143193 | 1752.7677359842833 | 1580.9476966318875 | 1430.1282696330288 | 1297.3473143944582 | | | | | | | | | | | | | | | |
| | | | | | | -0.05470884717444713 | -0.11905328406646842 | -0.0829934177626589 | -0.07288728378199127 | -0.07239039896020938 | -0.08990022160789712 | -0.10627770249475743 | -0.10347906760714098 | -0.10072511421187325 | -0.09802784238033035 | -0.09539811299271339 | -0.09284548670074344 | | | | | | | | | | | | | | | |