Found in my e-mail
Subject:
Biotech Holdings Ltd. Update Letter
Date:
Fri, 07 May 1999 23:53:25 -0700
From:
"Biotech Holdings Ltd." <biotech@direct.ca>
To:
biotech@direct.ca
Letter from the President, Biotech Holdings Ltd.
Vancouver, BC, May 6, 1999 -
There are important developments occurring relating to Biotech's
insulin-sensitizing drug, DIAB II, and its position in the growing
market for insulin-sensitizing drugs.
In Brazil, a human-patient study of DIAB II, conducted by one of the
leading Latin American contract research organizations, will be
completed this month. Data from this study, together with extensive
results from previous laboratory and clinical work on DIAB II, will be
the basis of the regulatory filing that is being prepared by
Biobras,S.A., Biotech's licensee for Brazil.
Biotech's licensed distributor for Argentina, Craveri, S.A., is also
looking forward to an early filing with regulators. Both Biobras - one
of the world's largest insulin manufacturers - and Craveri are leading
distributors of diabetic products in their respective markets.
Discussions with pharmaceutical firms in a number of other Latin
American markets are underway, including Chile, Venezuela, Peru and
Ecuador.
Investors will naturally want to evaluate the potential impact of the
recent approval of SmithKline Beecham's Avandia (rosiglitazone) on the
insulin-sensitizer market and DIAB II's potential market share.
The availability of an alternative to Rezulin (troglitazone), the
current best-selling insulin-sensitizing drug, is something that many
clinicians and Type II diabetics will welcome due to concerns regarding
liver toxicity associated with Rezulin.
The data now available on Avandia suggest however that Avandia may turn
out to be less of a "blockbuster" than expected. Indeed, there are
reasons to expect that Avandia, while expanding the overall
insulin-sensitizer market and possibly limiting the growth in sales of
Rezulin, will still leave the door wide open for a different and better
insulin-sensitizing treatment for Type II Diabetes.
Avandia is in the same chemical class as Rezulin - both are glitazones -
and appears to have some of the same drawbacks as well as other
characteristics that are cause for concern.
First, the FDA's advisory panel has determined that, based on the
clinical trials done to date, diabetics taking Avandia label will be
required to undergo regular liver-toxicity testing. This decision
suggests that Avandia may reduce but has not solved the risk of liver
toxicity that typifies glitazones. It should also be noted that the
liver toxicity posed by Rezulin - which has been associated with
approximately 30 deaths an a number of forced liver transplants -did not
become clearly apparent until the drug went into wide distribution.
Another troubling aspect of Avandia's profile is that more than 25% of
patients had increases of 30% or more in their LDL cholesterol ratio.
This is a critical issue for many Type II diabetics, who are already at
elevated risk of heart disease.
Thirdly, Avandia, like Rezulin, appears to be linked to weight gain.
Patients in the recently completed Avandia trial showed average weight
gain of 2 - 3 kilograms (4.4 to 6.6. pounds). Given that Type II
diabetics already tend to have a weight problem, it is difficult to
welcome a drug that tends to aggravate that problem.
Fourthly, Avandia may pose foetal toxicity risks, suggesting that women
of child-bearing age may need to exercise caution about taking the drug.
When all of the above factors are weighed, it seems clear that Avandia
may prove to be less important to the Type II Diabetes market than
anticipated and in fact has little impact on the world-wide need for a
different and better insulin-sensitizing drug. For these reasons, at
Biotech Holdings we believe that the door remains wide open for
Biotech's non-glitazone insulin-sensitizer, DIAB II.
Working with a series of strong local partners, Biotech is continuing to
progress towards its goal of bringing DIAB II to Type II diabetics in
markets around the world.
As DIAB II reaches important milestones in the coming months, I believe
that this progress will significantly benefit both Type II diabetics and
Biotech's shareholders.
Robert Rieveley
President |
