SECOND FDA PANEL REVIEWS GENENTECH'S <GENE> TPA
The federal Food and Drug
Administration (FDA) is expected to announce soon that it will
require an additional review of Genentech Inc's TPA heart drug,
a move that likely will delay the company's plans to
market the drug this spring, government and Wall Street sources
said.
    TPA, a bio-engineered blood-clot dissolving drug which
Genentech hopes to market under the name Activase, will be
reviewed by the FDA's cardiorenal advisory committee during the
panel's May 28-29 meeting, the sources said.
    Neither Genentech nor the FDA would confirm that a second
review of the drug had been set.
    "It's under consideration for the May 28-29 meeting," an FDA
official said. "It's on a draft agenda."
    Similarly, a Genentech spokeswoman said the FDA had not yet
notified it of the second advisory committee review.
    "We know it's a possibility, but as of this minute, we can't
confirm that we are on the agenda," she said.
    The spokeswoman said a second review had "always been a
possibility." But she declined to say how the review would
affect marketing plans before receiving official FDA word.
    The spokeswoman acknowledged that rumors of a second FDA
committee review had buffeted Genentech's stock yesterday on
Wall Street. The stock fell 2.75 dlrs a share to clsoe at 61.75
dlrs.
    TPA stands for tissue plasminogen activator, and would be
used on heart attack victims to clear blockage in a vein or
artery. Though other blood clot dissolvers are on the market,
TPA is said to be more effective and with fewer side effects.
    Analysts have projected the worldwide market for the drug
at as high as 1.5 billion dlrs a year.
    Stuart Weisbrod, a biotechnology analyst with Prudential
Bache Securities Inc., told Reuters the additional FDA review
likely would keep TPA off the market until at least November.
    Approval had been expected this spring.
    He said the FDA action prompted him to cut his estimate of
Genentech's 1987 earnings to about 40 cents a share from his
earlier projection of 67 cents a share.
    He said the delay would lower Genentech's 1987 revenues
from TPA to about five to six mln dlrs compared to an earlier
projection of 50 to 60 mln dlrs of 1987 revenues.
 Reuter
