INTERVIEW - Interneuron plans comeback
Reuters Story - October 09, 1997 14:54
By Ransdell Pierson
NEW YORK, Oct 9 (Reuter) - 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 Reuters.
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 , 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 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.
"(CerAxon) could become a $300 million drug and is
Interneuron's real story," said Harry Tracy, editor of
NeuroInvestment news letter.
On deck in the Interneuron pipeline is Bucindolol, now in
Phase III trials for congestive heart failure. "We hope to
file a new drug application for it in late 1998," Cooper said.
He noted that if approved by the FDA, Bucindolol would
compete head-to-head with Coreg, a new SmithKline Beecham Plc
drug expected to achieve annual sales of $500 million to
$800 million.
Next in the pipeline is Pagoclone, an experimental drug now
in Phase II/III trials for anxiety and panic disorder.
Cooper said he had hopes the non-sedating drug would be
submitted for FDA approval in late 1999.
((--New York Newsdesk (212) 859-1736)) |
