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LLY's rhAPC is a revolutionary biotech product and has a good chance to become the third multibillion dollar recombinant protein in history (after GCSF and EPO) within a reasonable time frame.
Sepsis, the first indication, was the 12th leading cause of death in the U.S. in 1997, more than homicide, HIV, atherosclerosis (CDCP statistics). Data suggest that APC successfully treats an otherwise fatal medical condition, severe progressive sepsis. At present, there is no drug for sepsis on the market. APC will be used in all of these severe cases. It will also be used in other, non-fatal or severe forms of sepsis, because it will improve outcome. I can imagine that APC will eventually be given to every patient with fever after surgery or delivery. This comes down to several hundred thousand, possibly a million APC treatments in this country alone. At an estimated very conservative company revenue of 10,000 per patient (or per life saved), the U.S. market for APC is estimated at $ 2B. Total global market (at present Europe, Japan, S. Korea, Singapore, Australia, Canada, U.S., Middle East) could reach 4-5B for sepsis and severe infections. The drug (and LLy) will obviously wipe out Xoma's expensive BPI (to be eventually approved for meningitis). Another expensive "sepsis drug" , Antithrombin (ATIII) is far less efficacious and will also be eliminated.
APC will also work in some other diseases but those are more competitive areas (stroke, heparin induced thrombocytopenia, heart attack, organ rejection, pancreatitis, peripheral vascular occlusion, etc.). APC, unlike the majority of blood drugs, is totally natural to the human body (just like endostatin for cancer, see ENMD), it is always present in the blood. It is also safer than the nematode protein, hirudin. APC is synergistic with tPA, heparin and other clot busters and will improve their safety and efficacy when used in combination. Unfortunately it will eventually also compete with Rheopro, not in the best interest of LLY.
Really good (ideal) drugs don't require monitoring. Unlike many other anticoagulants (at present heparin and coumarin, or clot busters, as USA today calls them), APC is very safe and does not require monitoring. It can be monitored, however, very easily with currently available tests, like APTT.
I can envision a total revenue of 6-7 B/year to LLY just from APC for many years to come. LLY, with its recombinant insulins, and now rhAPC, is to become the Amgen of the Midwest while remaining one of the best big pharmas.
Trust me, I know this one.
Hope you bought at 52.
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