A	B	C
1	Main
2		Brand Name	Vivitrol, fka Vivitrex
3		Generic Name	naltrexone, poly-(lactide-co-glycolide)
4		Indication	Alcoholism. As many as 20m alcoholics in the US. Likely 500k receiving treatment.
5		Reimbursement	VIP3 marketing/reimbursement program. 2000 physicians enrolled as of August 3rd, up from 400 at launch. Reimbursement proceeding.
6			covered as a medical benefit - product is appropriately priced - price has not been a barrier to physician interest
7			J-code for Vivitrol became effective on 1/1/07
8		Timeline	Approved 6/13/2006
9		Guidance	35-45m for 2006.
10		Dosing	qm injectable
11		Mechanism	mu-opioid receptor antagonist
12		Marketing	2-3k psychologists/psychiatrists were targeted by CEPH with 120 sales reps. ALKS has 28 MMD (managers of market development)
13			How large is the alcoholism market? How many rx for naltrexone are written?
14		Sales	Do not expect stocking. Ships from ALKS to specialty pharmacy.
15		Economics	CEPH returned product rights in 12/2008. ALKS sold Vivitrol to CEPH at cost, books sales as manufacturing revenue and records an offsetting COGS expense.
16		Sales	1.1, 2.3, 3.2, 4.1, 4.7, 5.0, 4.3, 4.8, 4.7 (Q207-Q209).
17		Papers	Naltrexone long-acting formulation in the treatment of alcohol dependence. Johnson et al. Therapeutics and Clinical Risk Management 2007:3(5) 741-749
18			Use of Naltrexone in the Treatment of Alcoholism Nationally in the Department of Veterans Affairs. Petrakis et al. Alcoholism: Clin and Exp Res 2006.
19		Competition	Naltrel (DrugAbuse Sciences, Elbion), DepoTrex, Campral (FRX), topiramate, Seroquel (AZN), disulfiram
20		Clinical Trials
21			Phase III n=600 published by Garbutt et al
22			S.S. lower percentage of heavy drinking days vs placebo, subgroup showed improvement was only in men.