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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?


To: Cacaito who wrote (14089)7/11/2000 10:36:27 PM
From: StockDoc  Read Replies (2) | Respond to of 17367
 
Baxter's (Immuno's) lyophilized PC is as pure as a plasma-derived immuno-affinity purified protein prep can be. By the way, outdated frozen plasma is dirt cheap, and 1 liter can yield 4 grams of pure and functional PC. That's a lot. Making APC, however, requires an additional step either before or after purification. Selected patients have been receiving Baxter's PC free of charge on a humanitarian basis since the early 1990s. None reported to acquire infectious complications. This is long and real human safety data and would work in favor of FDA approval of the plasma-derived products. rhAPC, at present, lacks this history on safety.

I don't know how much it cost to make rhAPC but it certainly requires making the product using a mammalian cell line for gamma carboxylation (yeast, planst, bacteria don't work). The culture media might contain proteome contaminants, viruses and prions. It is very very difficult to get rid of prions and the latency of prion diseases can be as long as 15 years. rhAPC is purified from the culture media. Advantage: it does not require activation. Purification of recombinant proteins from culture media is not at all easier or cheaper than purification from plasma.

However, I don't think that purity is a problem with either of these products, and I don't really care. They're both just fine.

I don't know how you figured the market but I stand by my sepsis market estimates. The market for rhAPC (or other sepsis products) is not all sepsis patients. Remember that sepsis is not a very bad disease in the age of antibiotics. Those who respond to antibiotics will not benefit from rhAPC or PC or BPI. And believe it or not, over 96% respond to current treatment. The 500 thousand cases developing sepsis every year is a conservative estimate, the number is probably closer to one million a year. Of these patient, approximately 4 percent dies (23,436 reported cases in 1998). The rest recovers (without rhAPC). Accordingly, 96% or less of the septic patients would not benefit from rhAPC. LLY thus decided to find those patients who would most likely benefit from the treatment, i.e., to identify those who were at high risk of death. This is a subpopulation of all septic patients, numbering up to 50,000 cases per year, and can be identified by determining their PC, AT, FVII levels and some other lab and clinical markers. There are commercially available tests for all of these markers and these tests will be used to select the patients for rhAPC treatment. It will be something like a mandatory screen for cancer cells before we administer chemotherapy.
By the way, I survived two septic episodes, and there are other sespsis survivors in my near family, all followed injuries and infections.

The insurance companies are aware of these facts and the expensive treatment will be covered only in those patients that likely benefit from the treatment. That number is less than 50,000 (more precisely, 23,436 cases in 1998). Come to the CDC web site if you have further doubts.