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Biotech / Medical : Biotime-Nasdaq's best kept secret? -- Ignore unavailable to you. Want to Upgrade?

To: Doug Shapiro who wrote (906)	5/3/1998 10:43:00 PM
From: Stephen How	Respond to of 1432

Doug, I'm pretty sure Pentaspan is approved for the US, but I don't know about it's generic status here. I don't know anything about what the FDA approval process for pentastarch would entail. I don't know why pentastarch is used as an albumin replacement in Canada, while it's not used here, especially in light of it's coagulation properties. I've received package inserts from Dupont Pharma for both Hespan and Pentaspan. For more info, you may want to contact either Dupont, or Dr. DJ Doyle of the University of Toronto, who runs a pentaspan webpage: home.inforamp.net Steve

To: Doug Shapiro who wrote (906)	5/10/1998 1:32:00 PM
From: Stephen How	Read Replies (1) \| Respond to of 1432

I was suprised to see that while FDA approved, Dupont's Pentaspan&reg is not indicated for treatment of hypovolemia in the US! The package insert for Pentaspan&reg in Canada reads: --- INDICATIONS AND CLINICAL USE: PENTASPAN&reg is indicated when plasma volume expansion is desired as an adjunct in the management of shock due to hemorrhage, surgery, sepsis, burns or other trauma. It is not a substitute for red blood cells or coagulation factors in plasma. --- In the US the package insert (Y36-002-349 [1997]) reads: --- INDICATIONS AND USAGE PENTASPAN&reg is indicated as an adjunct in luekapheresis, to improve the harvesting and increase the yield of leukocytes by centrifugal means. --- The effect of plasma volume expansion is described, but only in the description of clinical pharmacology. This may explain Abbott's interest in the agreement. The recent Biotime 10-Q states: During January 1998, Abbott notified the Company that Abbott is exercising their rights pursuant to Paragraph 11(b) of the License Agreement and will supply BioTime with batches of PentaLyte, characterization and stability studies and other regulatory support needed for BioTime to file for an IND and to conduct clinical studies. Abbott's actions preserve its rights to obtain an exclusive license for PentaLyte. Who is going to pay for pentastarch tests for hypovolemia? I hope Abbott is paying for the clinical studies. It looks like Abbott will supply "PentaLyte, characterization and stability studies and other regulatory support", but Biotime will file the IND and "conduct clinical studies". I would not like to see Biotime burn their remaining cash on these studies. Perhaps we need to see the entire License Agreement. If an albumin replacement will be such a blockbuster, why isn't Dupont trying to get FDA approval for Pentaspan&reg for plasma expansion in the US? Pentaspan&reg is already a big albumin replacement in Canada since 1993. Steve btim.dyn.ml.org