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

To: Jim Roof who wrote (918)	5/7/1998 5:49:00 PM
From: mesaone	Read Replies (3) \| Respond to of 1432

crossen's report was forwarded to me. These are the 6 points that he made (this is not the whole report). . but instead of speculating, i thought you should know what he said (forgive the typos.. my hands are really tired today). 1. Hextend is clearly not an oxygen carrying blood substitute and therefore the 1994 reference has not bearing on any issue related to the products approvability or use by physicians. However, bankers, seconded by lawyers write prospectuses and in 94 the company's bankers clearly made the decision to call hextend a blood substitute (it does literally substitute for blood to maintain normal volume and blood pressue and therefore organ perfusion) 2. If the volume replacement market is a $30 million market, then it consists solely of hespan, a standard hetastarch and does not include either crystalloids such as ringer's lectate and albumin. This is factually incorret. Albumin is widely used as a volume expander and crystalloids are also widely used. this is not rocket science. standard medical practice dictates that if patients lose 20% of blood during surgery or more, that blood is replaced by a volume expander. five million surgeries out of 27 million annualy involve the loss of 10.5 million liters of blood. while most of this market consists of low priced crystalloids, 1 million liters of hetastarch (at roughly $40. per liter) and 1 million lters of albumin (at $250 per liter) are used because physicians often want to avoid the adema caused in surgery by the use of crystalloids. with other uses, the effective market for a colloid such as hextend is 11 million liters in the US. alone. that is the market. the phase 3 clinical trial of 117 patients was sized to show equivalence of hextend to hespan, and this primary endpoint was met (as defined by urine output, heart rate and blood pressure) at the same time, 1.6 liters of hextend were used on average with a maximum of 5 liters used. hespan, the comparator drug, is limited to 0.5 liters in each patient. we believe hextend will have a label without a limitation on use and that this ability to use much more hextend without an enhanced bleeding risk will be a major marketing advantage over hespan. albumin is widely used at a much higher price than hespan because it does not require a limitation in how much can be used. at the same time, two major recalls of albumin for blood virus contamination have occured in the last two years. we belive hextend will easily replace albumin primarily because of a much lower price, but also because worldwide shortages of albumin and contamination risks.... The WSJ article stated that hextend failed to show an advantage over hespan and that additional studies in an ad hoc fashion are being planned to accentuate advantages but this may be too little too late. in this small study, 41% of patients did not get transfused. therefore, the patients who received blood transfusions were an especially small group and yet, in this group , the hextend patients experienced one liter less blood loss than the hespan patients (p<.03 in this small group). much more interestingly, every variable related to blood loss went in the same direction in favor of hextend. this includes fewer red blood cells transfused, less fresh frozen plasma used, less platelets used and less calcium transfused. in this study, however, eight out of 56 hespan patients experienced 12 adverse events related to clotting, whereas only two out of 59 hextend patients expereinced two adverse events. we believe that the market for hextend is real and large and that this product will be seen as having compelling advantages over hespan and albumin.