A	B	C	D
1	Main
2		Brand Name	Advair (US), Seretide (EU), Adoair (Japan), Viani (German).
3		Generic Name	fluticasone/salmeterol fixed combination.
4		Mechanism	Steroid/long-acting beta agonist combination.
5		Indication	bid maintenance asthma, stage III COPD
6		Market	7% of the United States has asthma, 500k hospitalizations. ~1.5m US patients versus 20m asthmatics. Albuterol emergency inhaler is 1L therapy.
7		Price	$2,500 per patient per year means 3.3 million people take Advair globally.
8		Competition	Inhaled steroids: Pulmicort (AZN), Flovent (GSK), Asmanex (SGP), Alvesco (SNY/AAA). Fixed-combination: Symbicort. Pills: Singulair (MRK's leukotriene antagonist). Spiriva.
9		Safety	adrenal suppression, glaucoma and decreased BMD possible side effects. label change and resurfaced fear in pediatric population.
10			Label changes?
11		Economics	Mitsubishi Tanabe co-promote in Japan?
12		IP	Salmeterol 5126375 expires August 2008. Device claims expire between 2008-2017. Sandoz/Vectura preparing ANDA.
13			GSK at Citi 2008: "Not particulary fearful about the 2010 date, we think Advair has a lot more runway than that".
14			5590645 device patent expires 11/1/2011.
15			5873360 device patent expires 8/23/2016. Blister pack patent.
16			RE40045 combination patent expires 9/7/2010.
17			Sandoz was first partnered with Vectura, but then discontinued the relationship and subsequently acquired Oriel (ex-GSK executives and device similar to Diskus).
18			Cipla, Respirics and Vectura.
19			Licensed some Vectura patents in 8/10.
20			German court rules Viani combination patent not valid on 5/20/2010. German patents still applicable for 2011/2012 as well as technical hurdles.
21			Irish court rules Seretide combination patent not valid on 6/26/2009. Other patents still exist with 2011/2012 expiry. IVX/TEVA challenger.
22		Lifecycle	THRX's Beyond Advair/Horizon.
23		Approval	COPD with chronic bronchitis November 2003: US
24
25		Clinical Trials
26			TORCH - stage II COPD study n=6000
27			17% relative reduction in mortality over 3 years for patients receiving 50/500mg vs place (p=0.052) narrowly missed significance
28			25% reduction in exacerbations vs placebo (p<0.001) with better QOL but more lower RT infections.
29				higher dose/higher price? - also COPD market expansion - 500/50 dose priced at 41% premium over currently approved dose for COPD 250/50
30			arguably not relevant given trial not compared to long-acting broncho-dilators
31			filed sNDA 10/11/2006
32
33
34
35			Alvesco - SNY/AAA - ciclesonide - FDA delay - combo with foradil
36			KOSP/SKYE flutiform - formoterol/fluticasone dry powder combo
37			QAB149 - Indacaterol - NVS - qd dosing - potential combo with asmanex
38			159797 - Beyond Advair - qd LABA
39			NVA237 - qd antimuscarinic in COPD
40
41
42			COPD mortality claim?
43
44			FDA mandated label changes
45
46			10% price increase - 4-5% increase going forward
47
48
49
50
51
52
53			16% reduction, HR=0.84