Here's what FT said about BBIOY yesterday:
BRITISH BIOTECH: Millar talks of his worries about
trials
By Jonathan Guthrie
Dr Andrew Millar, the recently-dismissed head of clinical
trials at British Biotech, the troubled biotechnology
company, revealed yesterday he had been worried about
results of trials on the company's acute pancreatitis drug
Zacutex in November 1996.
Dr Millar, who was dismissed a week ago for discussing
the company's internal strategy debates with
shareholders, said he raised his concerns about Zacutex
with Peter Lewis, a main board director.
The FT has received a copy of a letter the company
received in May last year from the European Medical
Evaluation Agency listing five serious objections to the
trials which stood in the way of Zacutex receiving
approval for sale in the EU.
The agency said that it was concerned that no
information was given on the screening process used to
select patients and that the reconstruction of missing
data by British Biotech should be explained.
Dr Millar was worried that the results of a US trial of
Zacutex - identified by the number 215 - were not
consistent with positive results from a small UK study
trial 214. As a result he "unblinded" the study - found out
which group of patients were taking the placebo and
which were taking the drug.
He told the FT the results were "inconsistent with the
Trial 214 and inconsistent with great optimism that the
drug would be effective".
He said he kept Dr Lewis up-to-date with results from
November to April 1997 but he did not share his
knowledge with subordinates running the trial so that
bias could not be introduced.
Although British Biotech had received the letter from the
EMEA last May, it did not announce until February this
year that approval for the drug was likely to be delayed.
British Biotech said last week it was in continuous
discussion with drugs regulators and it was inappropriate
to share all the correspondence with investors.
Documents obtained by the FT show the strength of the
objections raised by the EMEA. It said that evidence
that Zacutex reduced deaths among acute pancreatitis
sufferers was insufficient because it related only to a
sub-group of patients. The EMEA also questioned what
it saw as inconsistencies in methodologies used in the
trial and asked for information on the effect of different
levels of dosage.
The FT has also obtained a copy of a memo sent by Dr
Millar to directors including Keith McCullagh, chief
executive of British Biotech, on October 13 1994 which
raised concerns about potential harmful side-effects in
patients taking the anti-cancer drug batimastat.
In January 1995, Mr McCullagh sold a large position of
shares in British Biotech. In February, the company
announced delays in the development of batimastat,
which was subsequently dropped.
Dr Millar was dismissed for discussing internal strategy
debates at British Biotech with executives of Perpetual,
the investment manager with a 9.5 per cent stake in the
company. |
