A	B	C	D	E	F	G	H	I	J	K
1	Main
2		Brand Name	Levaquin
3		Generic Name	levofloxacin
4		Administration	Oral, IV
5		Label	http://www.levaquin.com/levaquin/shared/pi/levaquin.pdf
6		Mechanism	Member of fluorouinolone class of antibacterial agents. L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent.
7			Levofloxacin and other flouroquinolone antimicrobials inhibit bacterial topoisomerase IV and DNA gyrase (both are type 2 topoisomerases)
8			enzymes required for DNA replication, transcription, repair and recombination. Acitivity against Gram+ & - in vitro
9		IP	December 2010 expiration (June 2011). Court found MYL infringes on 12/23/2004.
10			Approved 12/20/1996, Expires 12/20/10, Pediatric Exclusivity until June 20, 2011. 3 year PTR included.
11		Economics	Daiichi is the patent owner. Marketed in Europe by SNY under Tavanic. US sales only, largely.
12		Competition	Trovafloxacin (Trovan by PFE?, gatifloxacin (Tequin by BMY)?, moxifloxacin (Avelox by Bayer)? Cipro (generic), Factive (OSCI), Ceftriaxone?(differnet class)
13		Clinical Studies
14			Phase III UTI n=1109 Levaquin vs Cipro
15			75.7% cure rate vs 75.2% for Cipro in mITT.
16			86.0% cure rate vs 89.2% for Cipro in evaluable population.
17
18			Phase III cSSI n=390 Levaquin vs approved comparator
19			84.1% cure rate vs 80.3% for comparator, SS not mentioned.
20
21			2 Phase III – Community Acquired Pneumonia: 7-14 day Treatment Regimen
22			Study 1 – n=590, unblinded randomized, 500mg levaquin a day for 7-14 days vs ceftriaxone IV 1-2mg / day followed by 500mg cefuroxime axetil twice a day for 7-14 days.
23			Patients were given erythromicyn (or doxycycline) if infection due to atypical pathogens was present
24			Clinical evaluation at day 5-7 and week 3-4 post therapy
25			Clinical Success (cure plus improvement), efficacy was 95% for levofloxacin vs 83% in control group (superiority achieved).
26			Study 2 – n=264, multi center, non comparative, 500mg IV or oral for 7 to 14 days. Clinical success was 93%.
27
28			Phase III – Acute Bacterial Sinusitis – 5 day (750mg) and 10-14 (500mg) day Treatment n = 780, double blind, double randomized, prospective, multicenter
29			Clinical Success – 91.4% (139/152) in 750mg group, 88.6% (132/149) in 500mg group at Test of Cure Visit. - comparison group
30			Antral tap results at test of cure (22 days post) were comparable between the 5 and 10 day group.
31
32			Phase III – Community Acquired Pneumonia: 5 day treatment. N=528. 750Mg (5 days) or 500mg (10 days) IV or Orally
33			Clinical Success rate – 90.9% for 750mg, 91.1% for 500mg.
34			31-38 days post enrollment – pneumonia observed in 7/151 patients from 750mg group, 2/147 from 500mg group, however it was not statistically significant due to low n#
35
36			Phase III – Nosocomial Pneumonia. N = 187
37			750mg IV followed by 750mg oral for 7-15 days vs. IV imipenem/cilastatin (500-1000mg) every 6-8hrs daily
38			followed by oral ciprofloxacin (750mg ever 12 hrs) for total of 7-15 days.
39			Levofloxacin – 7 days IV avg
40			Comparator – 8 days IV avg
41			Clinical success rate was 58.1% for levaquin and 60.6% for comparator
42			Microbial eradication rates at post therapy visit were 66.7% for levaquin and 60.6% for comparator.
43
44
45		Levaquin	2000	2001	2002	2003	2004	2005	2006	2007	2008
46		US		#ERROR_#REF!	#ERROR_#REF!	#ERROR_#REF!	#ERROR_#REF!	#ERROR_#REF!
47		ROW		#ERROR_#REF!	#ERROR_#REF!	#ERROR_#REF!	#ERROR_#REF!	#ERROR_#REF!
48		Total	1089	1052.3	1032.2	1149.4	1296	1492	1529	1646