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Greetings to all! The AntiCancer Ph III "Shakeout" is finally here to help launch our attempts to identify the real blockbuster candidates. We don't pretend to prophecy here, but are providing food for thought, individual DD, and commentary.

In the following table:
Group A represents those Ph III anticancer projects with the highest probability of entering the market within the next 3-4 years (possibly a year or so sooner with Fast Trackers). They either have received Fast Track status from FDA (indicated by *), have reported clinically significant improvements in survival times/disease progression (**), or are presently under NDA/BLA review (***). As such, these are the projects currently "leading the biotech pack" in the specified cancer. (We have included those for which an NDA/BLA was already filed, and for which the FDA has required more data or answers to specific questions--a delay, but not necessarily a long-term hang-up.)

Group B represents those Ph III anticancer projects that have neither received Fast Track status nor have yet reported sufficient clinical results on which to base a judgment re significant improvements in survival/disease progression. They may eventually graduate to Group A status, but at this stage of the game they are considered "iffy" with respect to achieving commercial revenues within the next 3-4 years.

Group C represents those Ph III anticancer projects with discouraging results that, barring some unforeseen miracle, appear to take them out of the running for any foreseeable revenue production.

For a first-pass calculation of market potential, you may consider using U.S. Incidence x Estimated Market Share x $10,000/year x 2 to 2.5 (the 2-2.5 factor being the approximate conversion of a population ratio of 2.5 to bring Western Europe and Japan into the equation, with sometimes higher prices in Japan's system and usually significantly lower prices in Western Europe). In estimating market share, remember that the best biotech anticancer drug yet, Herceptin, is designated to treat only those 30% of breast cancer patients who overexpress the her2/neu antigen. Remember also that some physicians will rule out or not consider your candidate drug for other reasons, such as a label that restricts it to advanced cancer only, or approves administration only with certain co-drugs. It will probably be a rare event that a given biotech candidate will have a market share of more than 20-30% of the incidence number. This calculation will give you a ballpark number to help you decide if a project has blockbuster potential at maturity. Realize that it will take a few years to ramp up to that level. (Having said all this, it should be emphasized that cancer therapeutics is one of the fields least satisfied with current drugs, and therefore one of the most likely to offer blockbuster potential to a clinically successful drug candidate.)

As the aim here is to identify not just successful biotech treatments for cancer, but potential blockbusters, Table 1 in the following post is limited to those cancers with an annual U.S. incidence of 50,000 or more. This excludes recent "miracle drugs" such as Gleevec, because they are aimed at low-incidence cancers. You should be aware that "market share" in these tabulated high-incidence states will depend on a treatment's effectiveness at various disease stages. Typically, a drug that is administered early in the progression of a disease will be used by more patients than one limited to late-stage disease. Counterbalancing this to a degree is the likelihood that a drug effective in late-stage therapy -- one that meaningfully prolongs life and/or quality of life -- will receive a price commensurate with its perceived value. Your study of the press releases about clinical progress will help you decide where, in the scheme of disease progression, your candidate drug fits. Then there are treatments designed for a broad variety of cancers, so that--if successful--adding the various indications creates blockbuster potential. One example is Genta's Genasense, an antisense oligonucleotide designed to inhibit the overexpression of Bcl-2, an apoptosis-regulating protein that protects tumor cells from the effects of chemotherapies, radiation, and monoclonal antibodies. Melanoma has been in phase III for a while, multiple myeloma and CLL have also entered phase III, and several other indications are in phase II. (Antigenics--not in this table--also comes to mind, as their autologous vaccine is potentially applicable to a variety of cancers. Renal cell carcinoma is in phase III testing, with others in phase II.)

So....Which are the top ten--or more--that you'd like to see in a Ph III AntiCancer portfolio? You tell us!!! And tell us why.

CHEERS....THE "SEMINAR" ANTICANCER TEAM (Barb, Cliff, Renee & Sheila)
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