Replies to post #188508 on Biotech Values

[DewDiligence]

OCRX +10%. I’m seriously wondering if the discussion on this board is what’s driving the move. (The stock is very thinly traded.)

[DewDiligence]

(OCRX)—Section of Xifaxan FDA label re HE indication:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf

1 INDICATIONS AND USAGE

1.2 Hepatic Encephalopathy

XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients = 18 years of age.

In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. Differences in the treatment effect of those patients not using lactulose concomitantly could not be assessed.

XIFAXAN has not been studied in patients with MELD (Model for End-Stage Liver Disease) scores > 25, and only 8.6% of patients in the controlled trial had MELD scores over 19.

Not indicated as a treatment for acute HE.

[DewDiligence]

(OCRX)—Bloomberg piece on HPTX buyout vig is somewhat bullish for OCRX:

http://www.bloomberg.com/news/articles/2015-03-27/hyperion-could-be-next-pharma-target-with-orphan-drugs-real-m-a

Hyperion Therapeutics Inc. could be the next [buyout] target in what’s already been a busy year for deals in the drug industry.

…Hyperion is preparing to start a phase 3 trial to test whether its ammonia-scavenger drug Ravicti can also treat hepatic encephalopathy, a neurological condition that affects patients with liver cirrhosis. Salix Pharmaceuticals Ltd.’s Xifaxan can be used to treat the same ailment so Valeant, which struck a deal for Salix this month, could go after Hyperion as well, said Yang of Brean Capital. Endo International Plc, which lost out in the bidding for Salix, could also be interested…

As previously noted (#msg-111690701), Xifaxan is not indicated for acute HE. Ravicti won’t be either, if it gets a label expansion for HE (https://www.clinicaltrials.gov/ct2/show/NCT00999167 ).