The Antidote: Inside the World of New Pharma (79 page)

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 of 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