rec. part 2.
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more of the recommendation
mesaone
Jun 9 1998
9:11AM EDT
further, while we have not seen the rest of the nda, we are confident that it includes all reelvant chemitry data
about the well known ingredients of hextedn, and the manufacturing data as supplied by the company's
manufacturing and marketing partner abbott labs. we are hopeful that teh fda will announce its acceptance of
hextend nda during the next week or two, and continue to expect an approval in about 12 months.
predicting the fda's action an any nda is highly speculative. the pivotal phase III trial appeared to demonstrate the
equivalence of hextend to hespan, based on the primary endpoints of urine output, heartrate, and blood pressure.
further, hextend patients who required an interoperative transfusion experienced one liter less blood loss than the
transfused hespan patients. the trial also appeared to demonstrate the products safety, in that it was given in
volumes up to 5 liters and in volumes in excess of 1.5 liters to 42% of the 59 patients who received hextend in
the trials. based on the clinical effectiveness, we see no reason why hextend should not be approved. and based
on the dosages used, we see no reason for the products label to carry any artificially low dosage limitations.
during the next several weeks, physicians at middlesex hospital in london are scheduled to begin another hextend
trial. the protocole for this study is not yet finalized, but it will probably involve 40-70 patients. investigators
will be using ether hextend or hespan as a plasma volume expander in similar groups of patients over 65 years
old undergoing high blood loss surgeries. management has long believed hextend's proprietary mixture of
hetastarch plus electrolytes and buffers will allow it to replace hespan and other volume expanders such as
colloids, crystalloids, and albumin. while the first trial was designed to show only that hextend could be used
safely and effectively in large volumes, this one should illustrate its superiority over other products when used in
a typical clinical setting. it should be completed early next year.
recently, abbott labs has begun publicly discussing its interest in hextend. we understand that the company to
have estimated the present US market for all plasma volume expanders at $400-$500 million, not just the limtied
$30 million existing hespan market. we continue to believe in the ability of abbotts sales organization to take the
hextend message to the wdest possible audience, and to help the product achieve anualized sales in te
neighborhood of $200 million within two years of the products introduction. based on teh ABT/BTIM marketing
agreement, that level of annual sales would generate revenues of approximately $92 million to BTIM .
as noted in the first paragraph of this research brief, we continue to believe in the prospects for both btim and its
lead product. the company should be starting toxicology and pharmacology studies on its follow up product,
pentalyte later this year, but we'll save further commentary on that productfor another time. we are more
frustrated by the performance of this stock than of that of any other equity in our coverage universe, especially
since its downward trend of the past 6 months has not been related to any tangible, fundamental changes in the
company's propspects. management of btim has been as forthcoming with information and as accurate in their
predictions about near term events as any managment team we have ever met. we continue to reccomend
purchase of this stock.
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