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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Michael Young who wrote (3534)	4/22/2001 10:54:48 PM
From: Biomaven	Respond to of 52153

<<ITMN>> Mike, A trial entry criterion is biopsy-proven IPF. There has now developed a consensus on IPF diagnosis from histopathology (usual interstitial pneumonia - UIP), so I feel they have a clearly defined disease entity. If you are interested in IPF and Intermune, the following monograph is very informative: Title: "New Approaches to Managing Idiopathic Pulmonary Fibrosis:" Summary: “New Approaches to Managing Idiopathic Pulmonary Fibrosis” is an educational monograph that was published by the American Thoracic Society (ATS) in September 2000. The monograph was developed from the proceedings of an ATS advisory panel held in April 2000 and reviews advances in the diagnosis and treatment of idiopathic pulmonary fibrosis (IPF), a life-threatening pulmonary disease. You can get a PDF of it at: intermune.com In particular, note the paper by the Austrian doctors on interferon-gamma in IPF and the following paper, which is an independent re-analysis of the Austrian's NEJM article. Personally, I put the odds of approval for IPF at well over 50%. Peter

To: Michael Young who wrote (3534)	4/22/2001 11:15:17 PM
From: IRWIN JAMES FRANKEL	Read Replies (1) \| Respond to of 52153

ITMN - Hi Mike - A response, <Drugs for ideopathic type conditions have a very dismal track record. Frankly, I'm not sure IPF can really be accurately defined for trial purposes.> It is not surprising that dealing with "ideopathic" diseases has been dismal. Likely, diseases described as "ideopathic" represented multiple diseases not a single disease. Thus, it would be partly luck to hit on a treatment that worked for enough of them to demonstrate the required P-value. So I agree with the first part of your statement. However, I part company on your conclusion. ("I'm not sure IPF can really be accurately defined for trial purposes.") Here is why. (My opinions were largely formed from attending the American college of Chest Physicians meeting last fall in SF.) Historically the disease that carried the label IPF included what are now several distinct diseases. Those distinct diseases can now be eliminated by a careful clinical and radiological workup. I watched (and talked to MD's) who carefully delineated the methods to identify IPF. Thus, it appears to me that IPF may really now constitute a single disease rather than a grouping of similar lung diseases. I do not want to represent that this is what the presenters were saying but it seems to follow. Admittedly, I am a lawyer with a very limited science background. Thus, if we really have a fairly well defined single disease it is more likely that we will find a single treatment to work. As always - I welcome criticism of my statements. After all, I want to get this right.

To: Michael Young who wrote (3534)	4/23/2001 9:53:42 AM
From: rkrw	Read Replies (1) \| Respond to of 52153

<<It can be a huge home run from here if they get IPF approval. Unfortunately I put the odds of that happening under 10%. Drugs for ideopathic type conditions have a very dismal track record. Frankly, I'm not sure IPF can really be accurately defined for trial purposes.>> Michael, I've talked to a number of pulmonary specialists. I've also corresponded with a handful of patients using Actimmune. Based on the feedback I'm getting, I put the odds of success at much greater than 50/50. $25M in off label sales expected this year. Piles of anectdotal reports. As IPF is a progressive disease there should be virtually no placebo effect. Given off label accessibility, fully enrolling the trial has been their only bottleck. This is a disease where nothing has been shown to be effective. The prognosis upon diagnosis in terms of mortality is worse than getting lung cancer. This is a potential breakthough drug and the anectdotal evidence continues to point to this. I'm not one to hype or tout stocks and I'm not trying to here. No disrespect intended but you should rethink your odds. RKRW