A	B	C	D	E	F	G	H
1	Main
2		Brand Name	Chantix (US), Champix (Ex-US).
3		Generic Name	varenicline
4		Mechanism	Alpha4-Beta2 nicotinic partial agonist. Nicotinic acetylcholine receptors are pentameric and the receptors with the highest affinity for nicotine contain 2 Alpha-4 and 3 Beta-2 subunits.
5			The highest concentration of Alpha4-Beta2 receptors is in the mesolimbic ("reward center") dopaminergic system. Binding results in dopamine release.
6			The receptors are ion channels and binding results in sodium (Na+) influx.
7		Cost	Pharmacoeconomic argument - $157bn in health-related economic costs.
8		Price	7/14/2007 price increase. ~$120/1mg (4 weeks). Recommended 12 week treatment program, with option of additional 12 weeks depending on severity of addiction.
9			Only $336 PPPY?
10		Market	Break down # of smokers in US/EU.
11			1995	1999	2001	2002	2003	2004
12			24.6	23.3	22.6	22.3	21.5	20.8
13			Europe - 30% avg in adults over the age of 15.
14			215m in EU, 45m in US, >100m in India, >300m in China. PFE notes 60% motivated to quit in the US.
15			2006 20.8% prevalence among adults.
16		IP	COM patent 6,410,550 issued 6/25/2002, expires 5/10/2020.
17		Guidance	>1B in 2010.
18		Notes	Once ban in smoke-free workplaces was implemented in NYC 2003, adult smoking decreased from 21.5 - 18.4% (-200,000)
19		Timeline	May 11, 2006 US approval. Launch August 2006.
20			September 29, 2006 EU approval. EU launch December 2006.
21		Competition	Head-to-head superiority vs Zyban.
22		Safety	Serious psychiatric symptoms can occur. Insomnia and abnormal dreams occur more than twice the rate of placebo.
23		Papers	Varenicline for tobacco dependence. Hays et al. NEJM 2008;359:2018-24.
24		Commentary	PFE Q207 10-Q: Chantix/Champix, the first new prescription treatment to aid smoking cessation in nearly a decade, became available to patients in the U.S. in August 2006, in select E.U. markets in December 2006 and in Canada in April 2007. Chantix/Champix continues to demonstrate strong uptake, with nearly 2.5 million U.S. patients having filled a prescription as of June 15, 2007, representing slightly more than 5% of adult smokers in the U.S. In the U.S., an unbranded advertising campaign introduced earlier in 2007 is working to effectively develop the market, and branded advertising is planned for the third quarter of 2007. We continue to focus on increasing adherence and have introduced tools to physicians that provide data behind the benefit of a full 12-week course of therapy. In addition, we are conducting several pilot programs to reach patients in their first month of therapy through pharmacy programs, as well as through our GetQuit behavior modification program. Champix has secured final approval from the National Institute for Health and Clinical Excellence (NICE) for use in the state-funded National Health Service in the U.K., following a positive appraisal decision in May 2007. Our strategy for this innovative medicine is to build a sustainable, medically supported market over time and to seek to secure reimbursement--initiatives that we believe will drive future growth. Chantix/Champix recorded worldwide revenues of $362 million in the first six months of 2007.
25		Clinical Trials
26			3659 chronic smokers (>=10 cigarettes/day) in six clinical trials - Label Summary
27			Abstinence from smoking was determined by patient self-report and verified by measurement of exhaled carbon monoxide (CO <=10ppm) at weekly visits.
28			Among Chantix-treated patients, the completion rate was 65%.
29			79-96% of subjects were white, average age 43 years.
30			subjects on average had smoked about 21 cigarettes a day for an average of approximately 25 years
31			all patients were provided with an educational booklet on smoking cessation and received up to 10 minutes of smoking cessation counseling at each weekly treatment visit
32			patients set a date to stop smoking (target quit date, TQD) with dosing starting 1 week before this date was set
33
34
35
36
37		11/13/2009		63426
38		11/6/2009		67278
39		10/30/2009		65729
40		10/23/2009		66093
41		10/16/2009		65550
42		10/9/2009		71143
43		10/2/2009		74816
44		9/25/2009		72361
45		9/18/2009
46		11/7/2008	64589	83261