by Barry Werth
patent issues and, 47–48, 101
Pharmasset and, 182–83, 220, 261–62, 324–25, 327, 329, 342, 347–51, 353–56, 359, 363
and proteases and protease inhibitors, 22–23, 32–35, 37–38, 40, 44, 49, 61–62, 76–77, 82–83, 91, 93–95, 101, 105, 128, 131, 140, 148, 151, 158, 172, 176, 220, 276, 289, 336
PSI-7977 and, 327, 329, 347–51, 355–56
resistance and, 62–63, 137, 140, 147, 150, 209, 220–21
shorter-duration treatments in, 135, 137–38, 149–50, 276
VCH-222 and, 199, 220
Victrelis (boceprevir) and, 172, 200, 208, 212, 228–31, 238, 245, 260, 263–68, 273, 275–77, 282–88, 299, 307, 311, 315–16, 341–42, 354, 374
VX-222 and, 215, 220, 262, 299–300, 325, 347, 355, 358, 362–63, 383
hepatitis C virus (HCV):
comparisons between HIV and, 21–23, 33–34, 38, 64, 147, 163–65, 183, 220, 262, 286, 356–57
genetics and, 32–34, 39, 47–48, 61, 94–95, 147, 183, 373
genotypes of, 137, 142–43, 150, 261, 275, 348, 355–56. 358, 373
replication of, 63, 101
screening assays and, 61–62
structure of, 22–23
testing for, 21, 203, 213, 277, 292–93, 300, 351, 374
Herper, Matthew, 251
high-throughput screening, 66, 78, 81, 86, 89, 205
Hoechst Marion Roussel (HMR), 47, 49, 51–52, 65
Hoffman–La Roche, see Roche
Houghton, Michael, 47–48
Howton, Ty, 367, 370
Huckman, Mike, 193–94, 216–17, 237
human bronchial epithelial (HBE) cells, 118–21, 125–26, 142–43, 179, 302, 344
human immunodeficiency virus (HIV), 49, 63, 127, 193, 219, 256, 350, 365
Agenerase and, 25–26, 28–32, 35–36, 46–47, 50–51, 56, 65, 77, 85, 92, 97–98, 102, 147, 186, 225
collaborations and, 12–13, 24–27, 31–32, 35–36, 46, 50, 53, 77, 85, 98
combination therapies for, 85, 146–47, 230, 357
comparisons between HCV and, 21–23, 33–34, 38, 64, 147, 163–65, 183, 220, 262, 286, 356–57
Cumbo and, 224–26, 229, 242
Lexiva and, 77, 97–98, 102, 111, 186
Merck and, 5, 14–15, 19, 24–26, 30–31, 36, 49, 94, 357
Murcko and, 13–14, 17–18, 28–29, 91, 335
patents and, 30–32, 35–36, 357
PK and, 25, 35
in prisons, 224, 229
and proteases and protease inhibitors, 13–15, 17–20, 24–32, 35–36, 46, 50, 76–77, 82, 147–48, 183, 220, 230, 242, 357
resistance and, 137, 140, 147–48
Vertex councils on, 18–19, 25
Vertex’s reorganization and, 64–65
VX-328 and, 18–19
VX-330 and, 18–20, 25
Humira, 317, 357
Huntington’s disease, 201, 380
Hurter, Trish, 336
HCV and, 112–14, 124, 132–33, 159–61
Incivek and, 168–69, 232, 239, 289
management style and skills of, 134–35, 158–61
hypertension, 4, 55, 261, 316
Idenix, 288, 352, 360, 373
Imclone, 216, 223
immunosuppressants, 128, 177, 227, 257, 277
IMS Health, 299, 307, 313, 315, 324
data misreported by, 327–32, 339–40
Incivek (telaprevir, VX-950), 295
AdComm and, 226–27, 230–31, 238, 240, 243–44, 255–58, 264–65, 268–76, 292, 344
all-oral HCV treatment and, 300, 341–42, 347, 363, 372
animal studies and, 112, 132
approvals of, 275–77, 284–85, 289, 316, 341–42, 344
black box warning on, 378
Boger and, 76, 109–11, 131, 136, 165, 178, 185, 189, 194, 200, 232, 239, 242, 244, 293–94, 316, 375
combination therapies and, 171, 215, 262, 300, 325, 347, 358, 363
commercialization of, 132–33, 160–61, 168, 176, 207, 212–14, 217–18, 222, 240–42
comparisons between Victrelis and, 260, 282–84, 288, 307, 315–16
DDIs with, 256–57, 268, 285
demand for, 327, 340–41
and Emmens’s interview with Huckman, 216–17
FDA and, 168–69, 171, 176, 185, 200, 208–9, 216, 222–23, 226–29, 233, 238, 240, 243–44, 264–65, 268–76, 285, 347, 369, 378
finances and, 83, 93, 109–10, 112, 129–31, 146, 167, 171, 176–78, 186, 194, 212, 247–48, 286–87, 289–90, 307–8, 313–16, 324, 326–33, 339–42, 344, 352–53, 355–57, 359, 362, 372, 378, 383
in human trials, 111–14, 121, 124, 128, 130–32, 136–39, 148, 150–51, 153, 155, 168–72, 182–83, 186, 194, 209, 212, 214, 220, 222–23, 231, 255–56, 268–72, 316
label of, 264, 276–77, 283, 285
launch of, 159, 168, 185, 189, 212, 216, 218, 224, 230, 240–43, 249, 259, 264, 276–94, 300, 303, 310, 313–16, 318, 324, 330, 332–33, 339, 341–42, 347, 356–57, 359, 365, 373, 378
Lilly’s rejection of, 83, 105, 110, 128–29, 146, 227, 239
Liver Meeting and, 82–83, 121, 124, 149–50, 155, 212, 231–32, 347–48
manufacturing of, 168–69, 173, 201, 239–40, 290
marketing of, 167–71, 176, 185, 187, 194, 200, 213–14, 238, 247, 264, 277, 282–83, 288–89, 311, 332–33, 341, 347, 355, 378–79
Merck-Roche partnership and, 287–88
Morgan conference and, 214–15
Mueller and, 109–11, 168, 201–2, 211, 223, 227–29, 232, 243–44, 258, 273, 276–77, 285, 288–90, 347, 355
NDA and, 194, 207, 222–24, 226–29, 231–33, 336
patient advocates for, 273–76
politics and, 167, 169
portfolio process and, 92–95, 99–100, 105
potency of, 106, 129–30, 137, 150–51, 194, 231
prices and, 194, 247, 277, 285–86, 288, 315–16, 324, 332
promotional literature for, 369
sales and, 212–13, 222, 224–26, 238, 241–42, 247, 277, 284–85, 299, 303, 307–8, 314–16, 325, 327–32, 339–42, 347–48, 350, 356–57, 362, 372–73, 375–76, 379
shorter treatment time of, 183, 275
side effects of, 151, 171, 182–83, 186, 257, 268–73, 275, 287, 344, 347, 378
successes of, 95, 101, 130–31, 139–40, 146, 359
supply chain for, 168, 185, 222, 239–40, 290, 310
sustained viral response (SVR) rates of, 151, 171, 212, 274–75, 282
inflammations, 23, 47, 53, 71–72, 80, 93, 177, 314
influenza, 237, 252, 314, 326, 335, 379–80
phenotypic screening and, 205–6
symptoms of, 61, 221
Inhibitex, 360, 373
inosine 5'-monophosphate dehydrogenase (IMPDH), 93, 99, 109, 183
insider trading, 74–75
interferons, 61, 129, 135–39, 148, 155, 165, 167, 171–72, 193, 208, 220–22, 229, 257, 262, 266, 274–75, 283–84, 299, 320, 348–49, 356, 373, 375
interleukin-1 beta-converting enzyme (ICE), 23, 38
crystal structure of, 29–30
pralnacasan and, 47, 49, 52, 77–78, 85, 87, 92–93, 99–100, 106, 129, 131, 146, 177, 215, 335, 368
Vertex-Aventis partnership and, 65, 77–78, 85, 99, 215
Vertex-HMR partnership and, 47, 49, 51–52, 65
InterMune, 220, 312–13
Internet, 43, 55, 58–59, 74
Intron A, 39, 61, 166
ivacaftor, see Kalydeco
Jacobson, Ira, 255–56
Janus kinases (JAKs), Janus kinase 3 (JAK3), 313–14, 335, 375
RA and, 177, 215, 317–18, 380
Japan, 12–13, 91, 193
HCV and, 42, 111, 149, 326, 378
Jobs, Steve, 45, 350
Johnson, Earvin “Magic,” 146
Johnson, Keith, 252–55
FEV1 of, 252–54, 307, 363, 371, 381
Kalydeco taken by, 252–54, 302–3, 305–7, 371, 381
and termination o
f Kalydeco study, 303–7
VX-661 and, 363–64, 372, 381–82
Johnson & Johnson (J&J), 207–8, 278, 372
HCV and, 149, 179, 357, 375, 378
Vertex’s partnership with, 149, 178, 186, 193, 216, 375, 378
Kalkeri, Raj, 94–96
Kalmar, Dawn, 295, 297
Kalydeco (ivacaftor, VX-770):
approvals of, 361–62
CF and, see under cystic fibrosis
FDA and, 303–4, 359, 361, 367, 369, 371, 377, 380–81
finances and, 250, 304–5, 327, 346, 353
in human trials, 140–43, 179–83, 186, 215, 248–55, 295–98, 301–7, 363–64, 367–71, 381–82
inaccurate data on, 367–70
Johnson case and, 252–54, 302–7, 371, 381
label of, 362
launch of, 249, 358
markets and, 343–46, 353, 361–62, 369
as monotherapy, 302, 313
NDA and, 237, 345
prices and, 305, 361, 377–78
sales and, 250, 343–44, 353, 386
successes of, 180–82, 248–55, 345
termination of study on, 303–7
VX-661 combined with, 363–64, 382
VX-809 combined with, 295–99, 301–2, 364, 367–70, 381
Karabelas, Argeris “Jerry,” 58, 88
Kauffman, Robert:
AdComm presentation of, 268–73, 275
CF and, 180, 248, 300, 302, 327, 351
on DDIs, 256–57
earnings calls and, 339–40
HCV and, 128, 130–32, 150–51, 183, 220–22, 227, 351, 356
Incivek and, 171, 201, 209, 222, 227–29, 232, 238, 240, 243–44, 256–58, 264, 268–73, 275, 285, 289, 295, 376
Merck’s AdComm and, 264, 267
mock AdComm presentation of, 256–58
NDAs and, 227–29, 232
Kelly-Crosswell, Lisa, 164–65, 167, 322, 334–35, 370
Kennedy, Ted, 214, 217
Kesey, Ken, 124
Kieffer, Tara, 148–51, 208–9, 232, 289, 336
Kim, Eunice, 18–19, 26
kinases, 53–58, 88, 107, 114, 206
see also Janus kinases, Janus kinase 3; p38 mitogen-activated protein kinase
Kissei Pharmaceutical Co., 12–13, 18, 25, 53, 75
Koppel, Adam:
CF and, 343–46, 352–54
HCV and, 345–46, 351–56, 362, 373
Incivek and, 287–88, 344, 352–53, 355
Kwong, Ann, 45, 80, 205, 379
HCV and, 39–41, 44, 49, 62–63, 82, 94–96, 101, 106–7, 148, 183, 262, 356
HIV and, 356–57
Incivek and, 208–9, 227, 229, 232, 265, 289
layoffs and, 89–90, 94–96
recruitment of, 39–42
Launch Week, 277–83, 293, 320
Lehman Brothers, 186
Leiden, Jeffrey, 375, 377, 386
CF and, 360–61, 367–69, 380
HCV and, 360, 362, 380
succession and, 357–59, 361
Lewis, Sinclair, 265
Lewis-Hall, Freda, 183–84, 200–201, 207
Lexiva (fosamprenavir, VX-175):
HIV and, 77, 97–98, 102, 111, 186
Porges on, 97, 102
Life Sciences Initiative, 156
lifestyle drugs, 46
Eli Lilly and Company, 43–44, 80, 316
HCV and, 44, 48, 61–64, 68, 75–76, 78, 82–83, 105, 110, 128–29, 146, 227, 232, 239
HIV and, 24, 63, 82
Vertex’s partnership with, 44, 48, 61–64, 68, 75–76, 78, 82–83
Lindbergh, Erik, 153–54
Lipitor, 6, 98, 195, 317
Little, Grady, 96
liver, 5, 32, 56, 105, 132, 237, 255, 318
HCV and, 42, 62–64, 82, 94–95, 101, 129, 138–39, 151, 167, 194, 203, 218, 256, 263, 292, 373–74
ICE and, 99, 215
Liver Meeting, 101, 209, 212, 230–32, 324, 343, 346–51, 356–57, 375–76
Gane’s speech at, 348–49
Incivek and, 82–83, 121, 124, 149–50, 155, 212, 231–32, 347–48
Pharmasset and, 333, 347–50
Lovers and Livers (Duffin), 165
lumacaftor, see VX-809
lungs, 67, 69, 80, 119, 125–26, 142–43, 179–80, 249, 252–53, 296, 302, 364, 367, 382
McCain, John, 176, 187
McColley, Susanna, 301–3
McHutchison, John, 207, 287–88
departure of, 255–56
HCV and, 138–40, 155, 182, 357
McKinsey & Company, 115, 287
McMinn, Rachel, 329, 331, 340–41, 343–44, 362
Mann-Hester, Kelly Ann, 273–74, 292–93
Marion Merrell Dow, 47
market capitalization:
of Merck, 15
of Pharmasset, 346
of Vertex, 185–86, 247, 283, 346, 357, 359, 365, 372, 382
see also stock market
marketing, 3, 4, 11, 55, 65, 120, 150, 238, 372
Boger and, 45
CF and, 120
guerrilla, 49–50
of Incivek, 167–71, 176, 185, 187, 194, 200, 213–14, 238, 247, 264, 277, 282–83, 288–89, 311, 332–33, 341, 347, 355, 378–79
of Lipitor, 6
by Merck, 98, 217, 284
off-label, 46, 65, 166, 195, 372
Roche-Schering war and, 61, 165–66
by Vertex, 26, 49–50, 160, 218, 240, 376
markets, market share (for drugs), 4, 5, 6, 12, 14, 36, 141, 165, 317
Agenerase (VX-478) and, 46, 50, 65, 98, 262
AIDS/HIV and, 5, 36, 46, 77, 183, 225–26, 229
CF and, 68–69, 301, 326–27, 343, 345, 346, 353, 361–62, 369
in China, 169–70, 172–74, 326
disease as opportunity for, 84, 139
FDA and, 137–38, 150, 171, 238
Incivek (VX-950) and, 93–94, 100, 149, 167–68, 176, 187, 213–14, 247, 282–84, 288–89, 293, 324–25, 327–28, 340, 341–42, 347–48, 360, 362, 363, 374, 378
JAK inhibitors and, 177, 317
Kalydeco (VX-770) and, 343–46, 353, 361–62, 369
Merck and, 19, 210, 238, 287
risk and, 92–93, 100
timing and, 41
Vertex and, 28, 45, 99–100, 102, 162, 171, 205, 218–19, 221, 238, 240, 314, 315, 324–25
Victrelis and, 283–84, 299, 307, 311, 316, 342
Vioxx pulled from, 121–22, 245
VX-740 and, 52
VX-745 and, 71–72
see also sales, selling, salespeople
Marks, Andrew, 74–75, 128
Markush structures, 30–31, 35
Martinez, Pedro, 96
Meacham, Geoff, 317–18, 332, 344
CF and, 297, 302, 365
Medicaid, 166, 305
Medicare, 166, 203–4, 208, 305, 312
Merck, 1, 13–16, 28, 46–47, 97, 101, 115, 160, 163, 224, 240, 244–47, 276, 282, 299, 321, 351, 385
AdComm and, 226, 230, 238, 244, 264–68, 272–73, 275
Boger’s background and, 3–5, 7, 15, 91, 94, 132, 134, 184, 381
commercial organization of, 260–61
comparisons between Vertex and, 88, 279, 291–92
corporate culture of, 161, 260–61, 278, 354
Emmens’s background and, 123, 210
finances of, 14–15, 168, 200, 245–47, 265, 283–84, 311, 342
HCV and, 22, 34, 44, 82, 200, 207–8, 216–18, 223, 226–31, 233, 238, 244, 249, 256, 260–61, 263–64, 284, 307, 316, 347–49, 357
HIV and, 5, 14–15, 19, 24–26, 30–31, 36, 49, 94, 357
honors of, 278–79
Hurter’s background and, 112–13
Ken Boger on, 278–79
Mevacor and, 14–15
Murcko’s background and, 13, 15, 324
NDAs and, 226–29, 231, 233, 238, 244
and pricing of Victrelis, 283–84, 286
Roche’s partnership with, 284, 287–88
sa
les and, 277, 284–85, 307, 311
Schering acquired by, 199–200, 217–18, 245, 260, 311
values and, 162, 245–46
Vertex’s partnership with, 107, 114
Vioxx and, 121–22, 228, 238, 245, 261, 279
Washington retroviral conference and, 26, 30–31
World War II and, 151–52
Merck, George, 97–98, 151–52, 247, 279
merimepodib (VX-497), 93–94, 99–100, 102, 105, 108, 128
Mevacor, 14–15
Milestone Day, 320–24, 327
Millennium Pharmaceuticals, 43, 55–56, 84, 86, 167
Mitsubishi, 111, 114, 169–70, 326
“Molecular Approaches to Drug Design” (Scolnick), 14–15
molecular subterfuge, 62
Moore, Jon, 88–90
J. P. Morgan, JPMorgan Chase & Company, 178, 297, 302, 317–18, 332, 344, 365
J. P. Morgan H&Q Healthcare Conference, 76–77, 84, 87, 101, 136, 139, 153, 192–93, 214–16, 237–38, 358, 360–61, 379–80
Morgan Stanley, 318–19, 321
Morningstar, 311
Mueller, Peter, 91, 126, 159, 281, 370, 380, 386
Boger’s relationship with, 163, 204
CF and, 127, 180–81, 201, 295, 297, 382
Condon’s hiring and, 167–68
earnings calls and, 339–40
East Asian prospects and, 326–27
HCV and, 93, 95–96, 108–11, 130, 161, 181, 183, 299–300, 347–49, 356–58
Incivek and, 109–11, 168, 201–2, 211, 223, 227–29, 232, 243–44, 258, 273, 276–77, 285, 288–90, 347, 355
layoffs and, 95–96
management style and skills of, 144–46, 161, 201, 206–7
Milestone Day and, 321–23
Murcko’s relationship with, 333–34
NDA and, 227–29, 232
nucs and, 299–300, 347
phenotypic screening and, 205–6
pressures on, 207, 222
reorganization of, 333–37
succession and, 196, 338–39
transformational life bell of, 289–90, 361
multiple sclerosis (MS), 93, 336–37, 380
Murcko, Mark, 30, 56, 65, 71, 113, 116, 143, 145–46, 157–58, 160, 218, 257
Boger’s relationship with, 28, 145
Boger’s retirement and, 196–97, 206
CF and, 80, 335
departure of, 334–38, 379
disruptive technology and, 145, 205–6
HCV and, 32–35, 37, 63
HIV and, 13–14, 17–18, 28–29, 91, 335
Incivek and, 222, 232, 289, 335
kinases and, 54–55, 335
Kwong’s recruitment and, 40–41
lawsuit against, 75–76
management style and skills of, 29, 79, 205–7
