ENCY/Myog/Tracleer: Hi Charlie & Board,
I will just add my opinion on Ency/Myog/Tracleer episode
Tracleer and Thelin:
The most important is safety. It is well known that Tracleer elevates liver enzymes more than thelin with a black box warning to its label. In a phase 3 clinical trial by Ency, the 100 mg dose of Thelin was associated with a 3% rate of liver function abnormality in the 18-week study, compared to 6% for the placebo.
In the study, Thelin also improved the distance patients could walk in a six-minute period over Tracleer, although the drugs are comparable in terms of efficacy.
Thelin also has a dosing advantage in that it only needs to be taken once a day, compared with twice a day for Tracleer. That should improve patient compliance and make it a more desirable treatment option.
Also Tracleer recently burnt it's finger by failing in Idiopathic pulmonary fibrosis trial and I think thelin will fail too but it is smart in not wasting it's resources.
Thelin And Ambi:
Ambi recruited all classes from Grade 1 to grade 4 Pulm HTN patients while Thelin went for grade 2 to 4 pts (More worse pts)
Ambi had a criteria that it took only pts who were able to cover 150m in 6min which implies its pts were more healthy.
Thelin liver function tests were more more worse in stride 2 than stride 1 with more pts. It might happen with Ambi too but at present Ambi's LFT's were more better than thelin's
Reg Ambi efficacy there was no tracleer arm to compare although it's results might be better.
Ency has 2nd gen drug in trials for Pulm HTN which may or may not be better than Ambi.
Thelin:
The best case scenario is thelin will get sales of 400Milion$ by 2010-11. The worst case scenario is it will only get sales of 200Million$. Either way investment in Ency will get good returns but might not be a great one with some if's and and's in between.
Dr.P
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