The marketplace for peptic ulcer treatments may changedramatically following a "consensus statement" released thisweek by the National Institutes of Health (NIH).
A panel of experts convened by NIH's National Institute ofDiabetes and Digestive and Kidney Diseases concluded that theestimated 25 million Americans who suffer from peptic ulcersat some point in their lives could have their condition cured bydual or triple treatment with bismuth and antibiotics. Mostpeptic ulcers, the consensus panel concluded, are caused by aninfection in the stomach and duodenum from a bacteria calledHelicobacter pylori.
Although the panel's conclusions are based on data that havelong been available, the pronouncement could have asignificant impact on several biotechnology industry players.Several companies currently market diagnostic tests that detectH. pylori, including Bainbridge Sciences Inc., Hycor BiomedicalInc., Whittaker Bioproducts Inc., Biomerica Inc. and QuidelCorp.
Bainbridge's vice president of marketing and businessdevelopment, Steve Van Leeuwen, told BioWorld that sales ofits pyloriTRAK diagnostic test have picked up in the past fewdays, but he noted that interest in H. pylori diagnostics hasbeen growing over the past three to six months.
"All the presentations (at the consensus conference) came fromdata that have been accumulated for some time," Bainbridgesaid, "but it hadn't been translated into sales" of H. pyloridiagnostics. Most product sales have been made in Europe, headded, because in the U.S., physicians have been conditioned toprescribe H2-blockers (such as SmithKline Beecham's Tagametor Glaxo Holding's Zantac) to patients with peptic ulcers.
Because the NIH panel's recommendation ideally calls for twodifferent antibiotics, such as tetracycline and metronidazole, aswell as bismuth, therapy may prove burdensome for patients."The consensus conference is the first stage," Van Leeuwensaid. "Next we need a more user-friendly therapy."
Glaxo's Tritec (ranitidine bismuth citrate) is currently in late-stage clinical trials as a therapy for peptic ulcers. Companyspokesman Rick Sluder said Glaxo is also consideringdeveloping a single agent that would combine Tritec and anantibiotic, as well as ranitidine (the chemical name for Zantac)plus an antibiotic. "There is no FDA-approved eradicator of H.pylori," he noted.
Van Leeuwen suggested that approval of Tritec would increasethe use of H. pylori diagnostics because Glaxo's large sales forcewould get the message about H. pylori out more efficiently thanthe NIH consensus panel.
Another agent that kills H. pylori could come frombiotechnology. Applied Microbiology Inc. of New York is inpreclinical development of Ambicin N as a therapy against H.pylori bacterial infection. Ambicin N, an anti-microbial protein,is currently sold under the brand name Consept as a topicaldisinfectant to prevent bovine mastitis. A representative of thecompany said that Applied Microbiology (NASDAQ:AMBI) isplanning to announce a strategic alliance regarding the ulcermedication in the next two weeks.
-- Karl A. Thiel Associate Editor
(c) 1997 American Health Consultants. All rights reserved.