[On Celebra] Doctors Report 'Positive Results' From New 'Super Aspirin' Heart Drugs
Bloomberg News
August 23, 1998, 9:58 a.m. ET
New 'Super Aspirin' Heart Drugs in Development Show Promise
Vienna, Aug. 23 (Bloomberg) -- Doctors say they are getting
positive results from clinical trials involving over 50,000
people with new so-called ''super aspirins,'' used to reduce
blood clot formation in patients at risk from heart attacks.
The new drugs in late-stage development from Monsanto Co.,
Roche Holding AG and Merck & Co. could be used by an estimated 5
million people in the U.S. alone, doctors said at the 20th
Congress of the European Society of Cardiology meeting in
Vienna. That's assuming side effect issues are resolved and the
drugs get approved, which is likely within the next two years,
they said.
The drugs, part of a class called glycoprotein 2b 3a
inhibitors, could open a whole new method for treating patients
who have had heart attacks or are at risk of them. Currently the
standard long-term therapy for such patients is common aspirin
or heparin, both of which inhibit the formation of blood clots
that can cause heart attacks.
''The news is very encouraging but we don't know all the
answers yet,'' said Neal Kleiman, associate professor of Baylor
College of Medicine in Houston, Texas. ''At least we know we are
on the right track.''
Kleiman is one of a number of clinicians who are testing
Roche's drug Sibrafiban and Xemilofiban, a drug developed by
Monsanto's Searle drug division, both of which are in the final
stage of clinical development.
These trials, which are sponsored by the drug companies,
involve over 8,500 heart patients. Results of the trials are
expected within the next year. If successful, the companies will
then file for regulatory approval, a process that can take
months or more.
Other drugs, including Searle's Orbofiban, are also in late-
stage clinical development and could enter a market for so-
called ''platelet aggregation inhibitors'' (PAIs) that
DataMonitor, a market research firm, now estimates is worth $6
billion and set to grow dramatically with the new entrants.
''We've have lots of encouraging results'' from Orbofiban,
said Robert Wilcox, cardiology professor at University Hospital
in Nottingham, England, who is testing the drug in a trial of
12,000 patients.
Sanofi SA and its marketing partner Bristol-Myers Squibb
Co. is also building market share with another kind of PAI
called Plavix that could generate $1.7 billion at peak annual
sales, according to HSBC James Capel analysts.
Kleiman told a standing room only crowd of hundreds of
cardiologists today that the key drawback to the drugs is
unusual bleeding in patients. From a clinical standpoint, the
bleeding is not serious unless the patient suffers a severe
injury. However, such bleeding can be a nuisance and result in
slower-than-usual clotting of minor cuts, such as from shaving.
''Their safety appears to be acceptable,'' he said.
The new oral drugs are chemically similar to new
intravenous drugs now on the market including Centocor Inc. and
Eli Lilly & Co.'s ReoPro, Merck & Co.'s Aggrastat and Cor
Therapeutics Inc. and Schering-Plough Corp.'s Integrilin. Roche
is also in late-stage development with a similar intravenous
drug called Lamifiban.
ReoPro, Aggrastat and Integrilin are growing in a market
for treatment of patients immediately before or after a heart
attack, particularly for those who have undergone an artery-
clearing procedure called balloon angioplasty. The new oral
treatments are expected to be used for weeks and months
following heart attack treatment and thus won't compete with the
intravenous drugs.
--Dane Hamilton in Vienna, through the London newsroom (44-171) |
