SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : wla(warner lambert) -- Ignore unavailable to you. Want to Upgrade?


To: Anthony Wong who wrote (608)3/24/1999 3:57:00 PM
From: Greg Jenkins  Respond to of 942
 
Here is the latest comments from AG Edwards:

Recent Development 3-18-99:

Again we disagree with the LA Times reports on Rezulin. The LA Times today contained another article on Rezulin and the FDA's handling of this drug. As with the previous article, we do not agree with the implications and conclusions brought forth in the article. We have two main criticisms: 1) The main claim of the article -that WLA's claim of a lower rate of liver problems associated with Rezulin use-is neither substantiated nor proven. 2) As with an earlier petition from Public Citizen, this article simply counts all adverse events reports from patients who were taking Rezulin as Rezulin associated deaths. This is simply incorrect, E.G., A patient who died in a car accident who was taking Rezulin should not be counted as a Rezulin associated death. Our read of the data is this. The number of patients who died, or had a liver death that could be related to Rezulin was 30 on 11-30-98, and had increased to 33 as of 2-3-99. We believe that the rate of liver related problems has in fact declined as WLA has stated. WLA has consistently made one important claim, that in properly monitored patients 0 liver deaths have occurred. However, in conversation with company management today, they have pointed out that the FDA is aware of two cases of patients who did reportedly receive proper liver monitoring, but still had some liver related "problems." The outcome of these patients is not yet known, and we point out that both patients had hepatitis and one had a history of a drinking problem. Clearly if proper monitoring does not catch all potential liver problems before they become serious, this is a negative for the drug and the company. It remains to be determined what if any conclusions can be drawn from these cases. In sum, we still place our bets on Rezulin. We believe that it is a safe and effective therapy for type 2 diabetics who receive proper liver monitoring. Further, we believe that weakness in the share price prior to the march 26 panel review represents a buying opportunity.
-------------------------------------------------------------------
See next post for another update.

Greg J.



To: Anthony Wong who wrote (608)3/24/1999 3:59:00 PM
From: Greg Jenkins  Read Replies (1) | Respond to of 942
 
Here is another update from AG edwards:

Recent Development:(03/22/99) GLX Romozin resubmission unsuccessful.
Glaxo announced today that it's type 2 diabetes drug Romozin was not approved
for reintroduction by the UK Medicines Control Agency (MCA), the UK's FDA.
Romozin is the same drug as WLA's Rezulin. Romozin was originally approved in
the UK, but under a label that did not caution patients about its potential
liver effects. Rather than changing the label, it was voluntarily withdrawn in
December 1997. As we stated back in December 1997, this decision may also be
related to GLX having an in-house drug in development (i.e. more profitable as
opposed to Romozin which is in-licensed from Sankyo). Rezulin is undergoing a
panel review of its post marketing and other safety data this Friday, March
26. This is obviously negative for WLA, but given GLX's past actions and the
choices it obviously has to make, we do not see this as a good indicator of
the type of review or outcome that Rezulin is likely to receive. We reiterate
our positive stance on Rezulin and WLA, and would view weakness as an
opportunity.