A	B	C
1	Main
2		Brand Name	Remodulin
3		Generic:	treprostinil
4		Indications:	PAH (Pulmonary Arterial Hypertension)
5		Administration	IV
6		Economics
7		Pricing	3.5% increase on 7/1/2006 to 100K a year. North of 100k in Q1 2009. 3/25/10 price increase of 9.6%.
8		Safety	Sepsis investigation ongoing by CDC. Report issued on 2/23/2007.
9			Remodulin shoewd a higher rate of BSI and gram- sepsis compared to Flolan. The CDC did not make recommendations.
10			2.6 higher BSI and 12.7 higher risk of sepsis. It is still very rare.
11		IP	5,153,222 (method of use) expires 2014. May 2009 orphan status expiry. Schoenebaum: "Tough to make, why hasn't anyone filed ANDA?"
12			Assigned to Burroughs Wellcome
13		Competition	Actelion's room-temperature stable Flolan?
14		Clinical Trials
15			Phase III P01:04 n=224
16			Failed to meet primary endpoint.
17			Median improvement in 6MW was 1 meter for placebo and 3 meters for Remodulin, p=0.06.
18
19			Phase III P01:05 n=244
20			Median decline in 6MW was 3 meters for placebo versus an improvement in 16 meters for Remodulin, p=0.06.
21
22			Phase II n=25 enrolled during 1998
23			Placebo declined by 6 meters from baseline at week 8.
24			UT-15 (Remodulin) increased by 37-39m at week 8.