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[IP] Insulin Licensing Agreements

Date: Fri, 19 Jan 2001 11:10:36 -0800 (PST)
From: Marina <email @ redacted>
Subject: [IP] Re: insulin-pumpers-digest V4 #794
Regarding the buffer in Velosulin, some have said that
it is the same buffering agent found in Humalog, but
according to the chemical diagram found in the sheets
that accompany each respective product, it isn't.
Velosulin, if I remember correctly, has a phospate
buffer, Humalog doesn't. My husband is a chemist, I
remember he compared the chemical makeup of each side
by side and did notice that there was a difference in
buffering agents, I'm just not positive that he said
it was a phosphate buffer but I could ask him when he
gets home. Anyway, my original point related to there
not being an insulin on the market that is rapid
acting (like Humalog) AND buffered (like Velosulin).
It would seem to me that if Novo Nordisk wanted to
enter the market for rapid acting insulins
(Novorapid), and bypass the patent that Lilly has on
Humalog, then why can't they request FDA approval of a
rapid acting, phosphate buffered insulin (BNovoRapid?)
so they could enter the U.S. market AND so that we
could have a choice of which type of rapid acting
insulin we'd like to use?

Its not the buffering but Humulog is not human Insulin. In Humulog the 
amino acids Lysine and proline are transposed on the B peptide chain Hence 
the name "Lispro". This change is what makes Humulog enter cells faster and 
do its thing faster. This is controlled by changing the genes  on the phage 
virus that they infect the e coli with,  Novo Nordisk doesn't use e coli 
but a yeast organism they would have to work out the virus they use to 
infect the yeast with. they would need FDA approval an expensive and 
lengthily process, This is America and in America we don't do patent theft 
that's why companies spend money to bring out new products and that is why 
they are sometimes available and sometimes not. Lilly has granted Novo 
Nordisk a License to repack Humulog but that means they are forbidden to 
change the buffering or it won't be the same product. anyway, I've used 
both BR and Humulog on the lab and there is no substantial difference in 
the buffering the pH of each is slightly different but that is only to 
control polymerization of the insulin  and prevention of fiber formation. 
They are both phosphate buffers. The buffering agent doesn't change the 
behavior of insulin, occasionally we make hamster or mouse insulin and use 
Acetate buffers that work just as well It is possible to make them more 
acidic than phosphate buffer. Spot The new aspartate insulin and glargine 
insulins require different buffers. so they stay soluble NPH is insoluble 
because it has a neutral pH and the insulin/ protamine complex is insoluble 
at pH 7 (Neutral) N=Neutral P= Protamine H=Hagedorn ( a Novo Nordisk 
Insulin Licensed to Lilly and others by International Agreement at the 
insistance of The Banting and Best Trust and Novo Nordisk A/S and the 
trustees of University of Toronto)  Spot
A Bender, M. D.
email @ redacted
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