A	B	C	D	E	F	G	H	I	J	K
1	Main
2		Brand Name	Gardasil
3			Gardasil 9, fka V503
4		Indication	Human papillomavirus (HPV) vaccine.
5			Genotype 16 and 18 of HPV are commonly associated with cervical cancer. Gardasil has 100% efficacy in protection infection against these two genotypes.
6			19-26 age cohort penetration will be a function of creating adoption through OBGYN.
7			Approved for men age 9-26 for the prevention of genital warts caused by HPV. 10/16/2009.
8		Price	$360/regimen - probably ~$300 realized
9		Guidelines	ACIP recommended females age 11-26 receive Gardasil. Also, added to VFC (vaccines for children) program.
10		Timeline	Cervarix filed in the EU in March 2006 and will file in the US in late 2006. Cervarix approved in the US 10/16/2009.
11		Papers	Flogging Gardasil. Nature Biotechnology Volume 25, Number 3, Pg 261.
12		Competition	Cervarix (GSK). Pap smear?
13		Reimbursement	UK delay - 3/8/2007
14			Mahmoud says FDA will require: pathology endpoint of reducing CIN2/3 lesions as well as infection rates.
15			Morgan has datapoint that says FDA would require 7-month antibody titres relative to natural infection.
16
17			MRK covers HPV 16, 18, 6 and 11
18			GSK covers HPV 16 and 18 (cervical cancer)
19
20			GSK using MPL which may result in longer duration of immunity.
21			However, MPL introduces uncertainty in the filing strategy.
22			Dr. Mahmoud - head of MRK vaccine
23			GSK vaccine meeting: 6/30/2005
24			Pricing is often thought to be near Prevnar
25
26			FUTURE II - quadravalent (Gardasil) 3-dose test with 4-year followup, n=11000
27
28				2006	2007	2008	2009	2010	2011	2012	2013
29			B of A					2800
30
31			government purchases 57% of all vaccines
32
33			MMR+Varicella	ProQuad	0	123.35	MRK	1 dose
34			Meningococcal Conjugate	Menactra	68	82	SAN	1 dose
35			Tetanus, Diphtheria, Pertussis	BOOSTRIX	28.75	35.25	GSK	1 dose
36			Influenza	FluMist	17.24	19-20	MEDI	1-2 doses
37			Pneumococcal	Prevnar	54.12	66	WYE	4 doses
38			Hep A/B	Twinrix	36.91	78.16	GSK	2 doses
39			Varicella	Varivax	52.25	66.81	MRK	1 dose
40			Hep B	Recombivax	24.25	59.09	MRK	2 doses
41
42			Leerink notes 27% penetration at 6 months and 59% at 2 years. 43% of formulary managers note plans will cover Gardasil.
43			Cowen notes 20% penetration at 12 months