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Biotech / Medical : Abgenix, Inc. (ABGX) -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (206)	5/31/2003 6:42:38 PM
From: Icebrg	Read Replies (1) \| Respond to of 590

Miljenko I do also hold some shares. But not so many that I am feeling uneasy about it - just unhappy. << I suppose Amgen would very much have preferred to say nothing at all at this point.>> I do not buy this at all. Never will. While there is agreement between investigator and sponsor to what and when results will be reported, ASCO is place where betel for market share and prestige intensify. I believe that there is a big difference here between bios and pharmas. And Amgen does sizewise qualify as a pharma. And their mindset when it comes to PR is like the pharmas. They prefer to keep most things under wraps until they are fairly well advanced and good-looking. Then they will unwrap and let the world have a look. They can afford to do so, as the valuation of their company is based on history and profit-driven. Whilst the valuation of the typical bio is based on the future and sentiment-driven. I know that (for example) Harry Tracy at a number of occasions has made remarks indicating that silence is Amgen's preferred mode of market communication. [Harry, if you read this - please confirm]. As for the investigator. This was a trial they inherited from the bio combo of ABGX/IMNX. It was initiated in December 2001. So, they had to let him say something. We'll have to wait for the abstract to know exactly what he had to say. Do you think that IF AMGN have something to say about any of their candidate (like what did DNA reported) they will be silent? NO! Future speed of accrual, investigator and pts excitements, cost of the trial, …all depend of the early data that candidate generated. You let news fly, if good! You cannot compare with DNA. They had what appears as a major success in a pivotal trial . They had to announce it (more or less). Amgen on the other hand - they are in an early phase II trial where we really shouldn't expect spectacular results. After all this was a monotherapy. Patient enrollment does not appear to be a problem. They say that they have almost recruited the 150 they need including the extension. Investigators will be excited about what they see in their clinic, not by what the company tells its PR-department to write. Just as idea that BMY can make AMGN life miserable in regards the ABX-EGF is enough. DNA and IMCL patents may not hold in real, but I will not bet that IF DNA can/may suppress both competitors (IMCL/BMY and AMGN/ABGX) will not try hard. Oh, I am not aware of the DNA patent problem. Is it specific to the mAb or to the target? >> They amended protocol with inclusion of the second CC group, those who do not express HIGH (+2 and +3) level of the EGFr, those with +1 expression>> I was not aware of that either. The original design called for 100 patients though. To have included +1 expressionists runs somewhat counter to the idea with the therapy. You know, I look upon phase II trials as a way to find out and make relatively sure that there is efficacy at the dose-level chosen. Of course not all companies do, but they should. So, from that point of view it doesn't appear to make much sense to increase from 100 to 150. If they continued to have a 65 % response rate, they would not be much wiser increasing the recruitment with 50 %. So, (in my mind) either they want to change some of the parameters (dose level or dosing intervals) or they want to build in more power into the study to be able to go to FDA and say: "Look here - we can stabilise 65 % of these very sick relapsing and/or refractory patients for x months. We think you should approve our drug based on that and we promise to continue with our phase III trial." Perhaps this is a new approach from the bios to do like Millennium did. To apply for approval based on a phase II, but at the same time to run a phase III, so that not much time is lost if FDA turns down the first NDA. That is of course very speculative, but what more can we do in the absence of facts. Erik