Annex 6
Dear Peter
Further to our recent telephone conversation
I am very happy to summarise the meeting that was held on 20 February
1997, at British Biotech to discuss the progress of marimastat.
On the basis of my experience in the pharmaceutical
industry and my more recent work in the Medicines Control Agency
evaluating new drug applications, you invited me to visit and
advise BBT on whether the pre-clinical and clinical data that
were then available for marimastat were sufficient to warrant
a submission to the MCA for a UK Marketing Authorisation Application
(MAA).
The meeting was attended by a small group of
BBT employees including yourself, Keith MCCullagh
and Dr Millar. Presentation of the data was made mostly by Dr
Millar, with some involvement of the company biostatistician.
Dr Millar reviewed progress and provided details
of the clinical evaluation of marimastat and was very positive
that the clinical trials showed significant benefit of marimastat
in cancer patients, sufficient to justify a potentially successful
MAA in the UK.
I advised the meeting that, in my opinion, the
MCA would only seriously consider an MAA for marimastat which
complied in all major respects to the recommendations contained
in the CPMP Notes for Guidance on Evaluation of Anticancer Medicinal
Products in Man, a copy of which I knew was available at that
time to Dr Millar and his team. If BBT were to obtain evidence
from only one well-controlled clinical trial showing that marimastat
significantly improved either overall survival, progression-free
survival or tumour response rate, then I recommended to the meeting
that an MAA based on such results would be very worthwhile making.
In conclusion, it was clear to me that at this
meeting Dr Millar was vigorously promoting the results of the
completed and ongoing trials with marimastat as representing a
sufficient scientific base on which to submit a UK MAA. At no
time did I hear him express any criticisms or reservations on
the design, conduct, progress or outcome of these clinical trials.
On the contrary, he seemed proud of, and satisfied by, the marimastat
clinical trial programme, the planning and execution of which
I assumed had been his personal responsibility. I was considerably
surprised, therefore, by his recent criticisms in the press of
these very trials, since his comments now seem at such variance
with his previously held views.
I hope this is helpful.
Yours sincerely
Denis Lockhart
21 July 1998
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