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Author: domsheldon1 Three stars, 500 posts Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: of 426  
Subject: Thoughts on GILD's new HBV drug . Date: 1/19/2000 6:29 AM
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I'm not here to give you a "buy" or "sell" recommendation , no , I'm giving you the Adefovir - HBV facts we know so far , and eventually it's up to you to decide whether or not you will buy Gilead .

Gilead's HIV drug is the same drug they are using for
the Hepatitis B Virus trials .
The drug is known as Adefovir Dipivoxil .
Important to know : Gilead canceled clinical trials
for HIV because their drug was too toxic , however for HIV they used 60 mg and 120 mg once per day , but for HBV it's only 5 mg , 30 mg and 60 mg once per day , thus it is expected to have less side effects .


I think it would be best to compare Adefovir with
Lamivudine because this one is already on the market
for HBV . (and for HIV -- better known as 3TC)

Note 1 : Lamivudine is a nucleoside reverse transcriptase inhibitor and Adefovir is a nucleotide rever.... .
For HIV , there are 6 such nucleoside .... on the market , but there's not even one nucleotide ... on the market !!

Note 2 : obviously , there's no phase III data available .
But let's have a look :
You should know that in HBV trials , the 3 most important markers are :
- loss of HBV DNA
- Loss of HBeAg = Hepatitis B e antigen
- normalization of ALT levels = enzyme which is an
indicator of liver damage .


Lamivudine = Heptodin = Zeffix :
----------------------------------------------
After 52 weeks of treatment , 52 % of lamivudine
recipients responded to the treatment . (100mg a day)
-- Loss of HBeAg in serum was noted in 32 %
-- Sustained suppression of serum HBV DNA to
undetectable levels in 44 %
-- Sustained normalization of serum ALT levels
in 41 % and they were less likely to have increased
hepatic fibrosis .
-- 16 weeks after stopping the treatment HBeAg returned
-- Viral suppression is effective only during therapy -- Viral resistance ( = mutations) to lamivudine has been observed ! In fact , mutations appear after 40 weeks of treatment .


Gilead's drug for HBV : Adefovir Dipivoxil :
---------------------------------------------
-- HBV DNA fell below detectable levels with 30 mg daily dose in 67 % of patients .
-- After 24 weeks : 27 % of patients in the 30 mg and
60 mg dose arms lost HBeAg and 20 % seroconverted .
-- I couldn't find info about the ALT levels .
-- To data , researchers have been unable to identify
resistant hepatitis B viral isolates associated with this drug . In addition , in vitro studies have demonstrated potent antiviral activity against all known lamivudine - and resistant HBV strains .


Is all this good or bad news ?
I don't know .
Adefovir 24 weeks --> no mutations
Zeffix 40 weeks --> mutations .
Important to note : In the case of Zeffix , longterm therapy is needed ! I assume this will be the same for Adefovir .Also , nothing is/was mentioned about possible side effects .

In the past , it has been estimated that Zeffix can achieve annual sales of over $ 300 million in 2000 and over $ 500 million in 2001 on the Hepatitis market .
I suggest you take a good look their sales number now .
Note : BCHE developed the drug , but I believe Glaxo
Smithkline markets the drug . BCHE receives royalties
on sales between 12 - 15 % .

Some of you on this board mentioned GILD's flu drug .
Tamiflu looks okay .
Gilead will receive royalty's off of Roche's sales .
I believe analysts are expecting to see $ 170 million in sales a year .
Analysts have been wrong before , so it could be higher
or lower .


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