A	B	C	D	E	F	G	H	I	J	K	L	M	N	O	P
1	Main
2		Brand Name	Lipitor		Generic Name	atorvastatin
3		IP	Ranbaxy settles 6/18/08 to launch generics 11/30/11.
4			5273995 reissued 3/17/09 as RE40667. Expires 6/2011 including pediatric exclusivity. This is a salt/R-trans patent. Ranbaxy FTF?
5			4681893 patent protects until March 2010 and claims racemate production process. Upheld in court and USCAFC, including patent term extension.
6			6126971 is a salt patent, expiring 2013.
7			5969156 is crystal form patent expiring 2016.
8			5686104 is stability patent expiring 2015.
9		Notes	5/25/06 - ML meets with mgmt and notes aggressive 2-tier formulary contracting (3-year deal with WLP to keep Lipitor on 2nd-tier).
10			Other growth drivers include SPARCL, pharmacoeconomic studies and lower cholesterol guidelines.
11			Mgmt feels low-cost statins will bring new patients to the market. Pharmacoeconomic analysis of IDEAL shows Lipitor adds more value than 75% discounted Zocor.
12		Indication	Dyslipidemia, ACS
13		Mechanism	HMG-CoA reductase inhibitor. Beneficial effects in acute coronary occlusion: remodeling/anti-inflammatory effects due to nitric oxide release. Anumal studies show reversal of hypertrophic cardiomyopathy.
14		Clinical Trials
15			IDEAL - patients with history of prior MI - failed to show PE benefit vs. Zocor (80mg Lipitor vs. 20-40mg Zocor), p=0.07
16			TNT - showed 22% reduction in events with 80mg vs. 10mg lipitor
17			SPARCL - showed 16% reduction in the incidence of recurrent stroke. PE: reduce second stroke with 80mg Lipitor - Published in NEJM - 2.2% absolute reduction
18			CARDS - 10mg Lipitor reduced CV events 37% and stroke by 48% in T2D patients.
19			REVERSAL - Lipitor had no plaque progresion vs. progression with pravastatin 40mg
20			ASCOT-LLA - atorvastatin vs placebo arm of atenolol vs Norvasc stopped early on events
21			PROVE-IT n=4162 Pravachol vs Lipitor. 26.3% vs 22.4%.
22			MIRACL - ACS study n=3086 placebo vs 80mg. 14.8% vs 17.4% primary endpoint.
23			SAGE - Lipitor 80mg vs. Pravachol 40mg showed sig. reduction in duration of myocarial ischemia
24			ALLIANCE - Lipitor reduces MI 47% vs SOC (post-MI)
25			BELLES - no effect on calcification as measured by Ultrafast CAT in postmenopausal women
26			BONES - no effect of lipitor on BMD
27			A to Z
28			CASHMERE - Failed to beat placebo in CIMT.
29			SSSS - Scandinavian Simvastatin Survival Study Group - Lancet 1994;344:1383-1389. Cholesterol lowering in n=4444 CHD to achieve secondary prevention.
30			Cholesterol and Recurrent Events Trial - Pravastatin on coronary events after MI in patients with average cholesterol levels. NEJM 1996;335:1001-1009.
31			LIPID: Prevention of CV events/death with pravastatin in patients with CHD. NEJM 1998;339:1349-1357.
32			L-CAD: Pravastatin initiated immediately after a coronary event. Am J Cardiol 2000;86:1293-1298.
33			Intensive versus moedate lipid lowering with statins after ACS. NEJM 2004;350:1495-1504. Cannon et al.
34			Early intensive vs a delayed conservative simvastatin strategy in patients with ACS. Phase Z of A to Z. JAMA 2004;292:1307-1316. de Lamos et al.
35			RECIFE - Cholesterol reduction rapidly improves endothelial function after ACS. Circulation 1999;99:3227-3233. Dupuis et al.
36			Statin therapy on ventricular late potentials in AMI. Intl J Cardiol 2003;90:63-72.
37			MIRACL--high-dose atorvastatin enhances the decline in inflammatory markersw in patients with ACS - Circulation 2003;108:1560-1566.
38			Benefits of early lipid-lowering intervention in high-risk patients: the lipid intervention strategies for coronary patients study. Clin Ther 2000;22:949-960. Pedersen et al.
39			MIRACL - Effects of atorvastatin on early recurrent ischemic events in ACS. JAMA 2001;285:1711-1718.
40			MIRACL - Effects of atorvastatin in patients with unstable angina or non-Q wave MI. Circulation 2002;106:1690-1695.
41			GRACE - Global Registry of Acute Coronary Events
42			PRISM - Platelet Receptor Inhibition in Ischemic Syndrome Management
43		Papers	The Editor's Roundtable: Statin Therapy in Acute Coronary Syndrome. Am Journ Cardiology Friedewald.
44		Price	1/1/07 5% price increase. Lipitor 874-1246 annual cost. Crestor 945, Vytorin 982, Zetia 913, Zocor 20-58.
45		HMO	Tier 2 or better for 70% of commercial lives through 2007
46		Efficacy
47			Drug	Tot. Chol	LDL-C	Apo-B	Triglyc	HDL-C
48			Lipitor	-29-45	-39-60	-32-50	-19-37	+5-9
49			Torcetrapib	NA	-11	-1	NA	+62
50			Crestor	-33-46	-45-63	-38-54	-10-35	+8-14
51			Lescol	-17-25	-22-35	-19-27	-12-19	+3-7
52			Niaspan	-2-12	-3-17	-2-16	-5-35	+10-26
53			Mevacor	-12	-17	NA	-35	+7-12
54			Advicor	NA	-45	NA	-42	+41
55			Pravachol	-16-27	-22-37	NA	-11-24	+3-12
56			Zocor	-23-35	-14-47	-29-39	-17-27	+5-8
57			Vytorin	-31-43	-45-60	-35-49	-23-31	+6-10
58
59			Crestor		Lipitor		Pravachol		Zetia		Zocor
60			5mg	2.47	10mg	2.28	10mg	2.75	10mg	2.27	10mg	2.27
61			10mg	2.47	20mg	3.31	20mg	2.79			20mg	3.97
62			20mg	2.47	40mg	3.15	40mg	4.1			40mg	3.97
63			40mg	2.47	80mg	3.15	80mg	4.1			80mg	3.97
64		Market	41m americans have elevated cholsterol (total over 240mg/dL). 12m treated patients, only 40% achieving goal cholesterol levels
65		RX
66			Lipitor				Crestor		Crestor		Vytorin		Zocor		Pravachol
67			TRx Y/Y	NRx Y/Y	TRx	NRx	TRx Y/Y	NRx Y/Y	TRx	NRx	TRx	NRx	TRx	NRx	TRx	NRx
68		2/12/2010
69		2/5/2010
70		1/29/2010
71		1/22/2010
72		1/15/2010
73		1/8/2010
74		1/1/2010
75		12/25/2009
76		12/18/2009
77		12/11/2009
78		12/4/2009
79		11/27/2009
80		11/20/2009
81		11/13/2009			1244936				553680		267299		1968344		413240
82		11/6/2009	0.16059951450905285		1302860				574381		279971		2044059		416568
83		10/30/2009			1264561				549275		270499		1966266		412101
84		10/23/2009	0.18308012307456356		1234272				542200		264541		1919054		391659
85		10/16/2009	0.15180250558340602		1201641				524453		257895		1854237		377304
86		10/9/2009	0.15812828646086508		1255623				539816		268125		1927398		395357
87		10/2/2009			1311075				562927		282165		2009078		413265
88		9/25/2009	0.16611351798846918		1256450				542271		270801		1909664		397841
89		9/18/2009
90		9/11/2009
91		9/4/2009
92		8/28/2009
93		8/21/2009
94		8/14/2009
95		8/7/2009
96		7/31/2009
97		7/24/2009
98		7/17/2009
99		7/10/2009
100		7/3/2009
101		6/26/2009
102		6/19/2009
103		6/12/2009
104		6/5/2009
105		5/29/2009
106		5/22/2009
107		5/15/2009
108		5/8/2009
109		5/1/2009
110		4/24/2009
111		4/17/2009
112		4/10/2009
113		4/3/2009
114		3/27/2009
115		3/20/2009
116		3/13/2009
117		3/6/2009
118		2/27/2009
119		2/20/2009
120		2/13/2009
121		2/6/2009
122		1/30/2009
123		1/23/2009
124		1/16/2009
125		1/9/2009
126		1/2/2009
127		12/26/2008
128		12/19/2008
129		12/12/2008
130		12/5/2008
131		11/28/2008
132		11/21/2008
133		11/14/2008
134		11/7/2008			1122575	337278			366666	122355	277672	80237	1456845	472225	285700	95102
135		10/31/2008
136		10/24/2008			1043270	315823			337257	113989	262636	76234	1342025	446292	263570	88767
137		10/17/2008			1043270	315823			337257	113989	262636	76234	1342025	446292	263570	88767
138		10/10/2008			1084183	326304			349957	117208	273062	78661	1377413	460702	268780	89714
139		10/3/2008
140		9/26/2008			1077468	327911			341434	115173	271605	78151	1341811	467422	262879	88483
141		9/19/2008			1068721	326103			335336	114108	272695	78520	1329844	473081	258922	86978
142		9/12/2008
143		9/5/2008
144		8/29/2008
145		8/22/2008
146		8/15/2008			1071035	304626			333303	105689	278519	75857	1328758	460202	255717	80234
147		8/8/2008			1102924	330100			337562	112241	295350	84566	1332313	499433	258087	85574
148		8/1/2008			1111568	331983			339824	113623	297938	85087	1328223	493634	256863	84489
149		7/25/2008			1064350	323461			325204	110435	286253	83253	1272391	471861	245845	82199
150		7/18/2008
151		7/11/2008
152		7/4/2008
153		6/27/2008			1097626	334955			328162	112676	305798	89079	1262484	430535	244748	82141
154		6/20/2008			1085854	332164			325513	111389	304164	88640	1254038	418719	244074	81896
155		6/13/2008			1096990	335427			324610	110347	308439	89439	1249507	410741	243627	80864
156		6/6/2008			1180313	356659			346921	116333	334600	95244	1339610	436458	258135	84643
157		5/30/2008			1034153	304092			302172	99025	295583	80785	1171586	370755	227255	72679
158		5/23/2008			1093517	335876			321678	110927	314551	90211	1237003	413427	240880	81245
159		5/16/2008			1097560	337807			321467	110885	316192	89770	1235906	418399	239407	79796
160		5/2/2008			1166306	355012			335348	114439	339650	94995	1292901	432797	248171	82915
161		4/4/2008			1183952	363506			333850	114883	350417	99475	1279837	440822	242924	81589
162		2/29/2008			1150494	366738			312554	109493	380219	114578	1181871	413072	219469	77044
163		2/28/2008			1100449	354021			302041	106269	364323	110031	1072550	378179	208645	73266
164		8/10/2007			1221454	361618			302735	101123	430336	136145	949365	319579	197625	64311
165		8/3/2007
166		7/27/2007
167		7/20/2007
168		7/13/2007
169		7/6/2007
170		6/29/2007
171		6/22/2007
172		6/15/2007
173		6/8/2007
174		6/1/2007
175		5/25/2007
176		5/18/2007			1247116	378113			298905	101563	417761	136009	900625	309194	195188	63480
177		5/11/2007			1284240	390754			304049	104454	425365	139098	917785	317755	199524	65198
178		5/4/2007
179		4/27/2007			1267538	388603			296076	102731	416712	138082	882758	309148	195033	63464
180		4/20/2007
181		4/13/2007	-0.11	-0.12	1280780	387310			296843	101859	414757	136497	872596	303569	193011	62235
182		4/6/2007	-0.1	-0.13
183		3/30/2007	-0.1	-0.12
184		3/23/2007	-0.12	-0.14
185		3/16/2007	-0.11	-0.14
186		3/9/2007	-0.11	-0.15
187
188
189		1/26/2007			1303591	414213			287525	102818	388789	134920
190		1/19/2007			1282006	412825			281699	102426	382442	134348
191		1/12/2007	-0.07	-0.13
192		1/5/2007	-0.07	-0.14
193		12/29/2006	-0.09	-0.13
194		12/22/2006	-0.07	-0.1
195		12/15/2006	-0.07	-0.1			0.57	0.57
196		12/8/2006	-0.04	-0.07			0.6	0.58
197		12/1/2006	-0.08	-0.12			0.56	0.55
198		11/24/2006	-0.09	-0.11			0.59	0.6
199		11/17/2006	-0.09	-0.13			0.57	0.54
200		11/10/2006	-0.07	-0.11			0.6	0.58
201		11/3/2006
202		10/27/2006
203		10/20/2006
204		10/13/2006
205		10/6/2006
206		9/29/2006
207		9/22/2006
208		9/15/2006
209		9/8/2006
210		9/1/2006
211		8/25/2006
212		8/18/2006
213		8/11/2006
214		8/4/2006	-0.05	-0.07
215		7/28/2006	-0.04	-0.04
216		7/21/2006	-0.05	-0.06
217		7/14/2006	-0.05	-0.07
218		7/7/2006	-0.04	-0.07
219		6/30/2006	-0.06	-0.07
220		6/23/2006	-0.04	-0.05
221		6/16/2006	-0.05	-0.09
222		6/9/2006	-0.02	-0.05
223		6/2/2006	-0.03	-0.06
224		5/26/2006	-0.01	-0.05
225		5/19/2006	-0.03	-0.06