10/9/97 Interview text
Interneuron Pharmaceuticals Inc said on Thursday
a pipeline of three potentially major new drugs could begin next year to
revive the company's prospects following its recall last month of the
obesity drug Redux.
"Our future products were always of greater importance to us than Redux,
because they address very large medical needs and large market
opportunities," Interneuron Chief Executive Glenn Cooper told Reute
Moreover, Cooper said Redux appeared to have had little or no roll in heart
valve damage seen in patients that took Redux (dexfenfluramine) or a
combination of two older obesity drugs Pondimin (fenfluramine) and
phentermine.
Interneuron and its marketing partner, American Home Products Corp (AHP.N),
withdrew Redux after the U.S. Food and Drug Administration disclosed that
echocardiograms showed about 30 percent of a sample of 291 patients taking
one or more of the three drugs had heart valve abnormalities.
American Home also recalled fenfluramine, which it manufactured.
"We feel fully confident of defending Interneuron against any litigation,"
Cooper said, adding only two patients with heart valve problems in the
patient sample had taken Redux alone.
He said Redux had unfairly been "lumped in" with patients taking the
so-called fen-phen combination believed responsible for the lion's share of
the heart valve cases.
Rather than looking back at its Redux setback, Cooper said Interneuron was
preparing to seek FDA approval by year's end to market stroke drug CerAxon
(citicoline).
Cooper said he expected the FDA to give CerAxon fast-track review, meaning
it could be launched by mid-1998 if approved.
Cooper contended CerAxon has pronounced advantages over the only other major
drug now available to limit damage from stroke, Genentech Inc's (GNE.N)
Activase (t-PA).
"Activase is quite effective for those who get it within three hours of
having a stroke, but CerAxon is effective if given within 24 hours," Cooper
said.
He added CerAxon had only minor side effects, whereas clinical trials showed
six percent of patients taking Activase experienced potentially fatal
intracranial bleeding. |
