[Letter to Victor Zonana and Bill Grigg from Tom Flavin]

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08/24/93 15:37 10301 498 001~7 OC 1 00;1 a.. 0.4r brand Iax trurim~fl* memo 771te p.

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r o o -Ov3CtOrZ on&l&, Bill Grigg
R~e M icro en~ys assertion that NIB bu~ys rese~arch products
Inquiry by Paul R~owe of Lan~cet
Foul Rowe had been faxed by Volvoviti thea aam paocae~ of
''supportin'g materials" that Vi.ctor received about NTIH purchases
of vaccines and other pharmaceu~tials.
WICiD (Child Health) did purchase the DTP vaccine on a sftraight
contract. The peitusais component was Invented by tin NIB
scientist, Paul Seruka,NI does not have a vaccinim factory, we
were really just hiring a company to make the product in
thousands of doses for us to una in a large clinical trial.
The WINDS (Neuroloqy Tnatituta) d~oes ptirohaao the rer~lana.ment
enzymes for Gaudier's and 1abry'us disease clinical trials. The
Gaucher's disease enlzyme was originally supplied free by Genzymne
from ' 89 to 191 during preoliminiary tte tuzrn $3,9 million
worth. Then the enzyme product was given orphan drug statue by
the FDA to Genzyme, meaning they are the sole xanufacturer and
supplier of the product.
Genzymo has applied for or-phain drug status for the liabry' a
di sease enzyme, but at the moment anyone can make it, the*refore
the contract to supply it was wine open for b.dB5.
The!IAID has CRADAt' (Cooperative ReseEarch and D velopment
Agreeements) with both Jxwuno AG~ to provide GP'-160 vaccine for a
clinical trial and with Cetus/Chiron to provide IL-2 for a
clinical tr{&.l for AIDS patients. CAflA' s are almost barter
agreemente where corporations trade their products in exchange
for our expertise in conducting clinical trials. If the product
proves succ ss ful, thoy have the l iconing and/or patntdng
r ightQa. If it fails, then NIH has spent less money findingj out
that this particutar therapy won't work. Money is alm~ost never
exchanged as parxt of as CRADA, it is rath r a negotiaitedi agroiemant
to conduct a joinitexperiment.
I provided this into both to Paul Rowe and to Paul Reaer of AP.
Tom Flavin
(301) 496-"5787

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