A	B	C
1	Main
2		Brand Name	Cayston
3		Generic Name	aztreonam lysine
4		Indication	Cystic Fibrosis related pulmonary infections - 30k CF in the US, 30k in EU.
5		Mechanism	antibiotic against pseudomonas aeruginosa and Burkholderia cepacia gram negative bacteria
6		Competition	TOBI - inhalable tobramycin, Pulmozyme (inhalable dornase alfa), inhaled bronchodilators and steroids
7			TOBI is poorly tolerated and susceptible to viral resistance
8		Administration	Inhaled nebulizer which takes 3 minutes. TOBI is 20 minutes.
9		Timeline	9/16/2008 PDUFA date. FDA requesting more studies. EMEA changed opinion in June 2009--expect approval 3 months thereafter.
10		Clinical Trials
11
12
13			AIR-CF2 Phase III study
14			n=247 cystic fibrosis patients with P. Aeruginosa infections.
15			Met primary endpoint: time to need for inhaled or IV antibiotics.
16
17			AIR-CF1 Phase III study
18			75mg inhaled of Cayston vs placebo given for 28 days.
19			QOL endpoint requested by FDA. 10 point difference was found. 5 points is considered clinical advantage.
20			FEV1 improved significantly, similar to TOBI except in older patients.
21			cfq-r score was primary endpoint.
22
23			AIR-CF3