Part 2
HORSESHOE98
Apr 1 1998
8:57PM EST
I am concerned that investors may be setting themselves up for disappointment when I read predictions of REMUNE approval in
May. While the independent data safety monitoring board will review the data at the end of the quarter, there are several
possible outcomes. The surrogate market data could be enormously compelling and for reasons of compassion for the infected patients,
they could recommend stopping early and submitting the data to the FDA for approval. Or, based on the same data, they could
recommend that the trial continue to its scheduled completion in March 1999, to satisfy even the most ardent disbelievers. And
finally, if the data were bad, they could recommend halting the testing altogether. I don't think the third option is realistic. In
my opinion, there is a growing consensus that REMUNE is headed for approval. The results that REMUNE has shown as presented in
various publications and forums--increased beta chemokine production, decreased TNF (tumor necrosis factor), increased CD4 cell
count, and weight gain, all seem positive. I expect that we will get FDA approval, but I am not counting on it coming in May.
Actually, I think that it is more realistic to look to Thailand for early approval. They do not have a viable treatment for AIDS
patients, and the disease is fast becoming a major problem.
Once approved, I believe that the market penetration for REMUNE will be much greater than many expect. REMUNE could be a
stand-alone therapy for early stage treatment, as well as a supplement to current "cocktail" therapies. In the 10K, the Company noted
that only 20% of those infected are on "cocktails," and up to 50% quit because they cannot follow the arduous schedules that
require taking pills up to eight times a day. For many in the US, and most outside this country, REMUNE, with its single quarterly
injection, could become the treatment of choice. It is important to remember that there has never been a drug that could kill a virus.
It can be driven to "undetectable" levels, but it still remains in the body, and once the patient stops taking the drugs, the
virus comes right back to its previous levels, or worse, mutates and becomes even more virulent. Real, lasting treatment of
viruses must involve the immune system. In reading the 10K, I was reminded that patients in the initial Phase I test back in 1987
are still taking REMUNE. While the Company can only comment on safety since that was the endpoint of the trial, it is certainly
encouraging to me as an investor that some patients have been successfully treated with REMUNE for over ten years.
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