Icos'Pafase phase II success. Competition: xoma,Chiron,LLY
xoma is ahead with completed phaseIII, bpi near BLA. But xoma has been secretive about the results, except to say that the drug showed "benefits".
But, xoma initial approval (if ever approved)will be for a subset of sepsis, they will have to do subsequent trials for the other clinical situations.
Chiron is also ahead with Tifacogin already in phase III. Chiron has not release the results of phase II, except to say they were good to go ahead with phase III.
Lilly's drug is somewhere in phase II?
Icos has another drug the IC14 in phase I, not to confused it with Pafase.
Icos is planning to start Pafase PIII in Q4 2000, kind of late, I guess they have their reasons. I could not be lack of money since they are well capitalized, maybe they want a partner or a financier.
Pafase does not kill bacteria netither block bacteria nor its products, it interferes with one of the inflammatory cascade components.
Tifacogin does not kill bacteria, it blocks irregular activation of clothing factors.
Bpi kills bacteria and inactivates their proinflammatory debris, but like the others works better with antibiotics.
Pafase,tifacogin,bpi,IC14 and lilly's drug work at different sites of the sepsis/schock cascade, so they could eventually be used together as a very expensive cocktail to
increase each other activity, and at least for the first three the combination should not interact in detriment like more side effects.
My view is that if Bpi does work as expected it will be the first drug if infection is on the line, once schock starts Pafase should be logical next step, and Tifacogin will be and add on when DIC (irregular coagulation/bleeding) is suspected. Of course, first all of them should be approved before this scenary could be a reality.
But, for the trauma patient Pafase will be the first on, follow by Tifacogin in the more complicated cases. Bpi was already a failure in trauma with non infectious causes (as expected), and in the infectious subgroup (some 10%)they either do not have enough numbers or did not have an effect.
Icos pII has an advantage to evaluate and translate results probabilities into a pIII than xoma's pII. Because xoma's pII was originally a I by design and for the strength of the data accepted as a pI/II and given ahead to go to pIII by FDA. But xoma's pI/II was not blinded, and did not have concurrent placebo control subjects, it had historical control subjects (not the same reliability)(This will be soon a non important point in turns of xoma's bpi since they have a pIII completed and "benefits" and once the data is out that's it).
The point is that Icos does have a double blind, phase II with concurrent placebo control subjects and very good number of subjects, 240, that gives very good predictability to the data, so good that they were able to claim clinical benefit and statistical significance.
Summary: # 1 Icos now is a very strong 2 drug company and the market value should double or triple accordingly in the next 2 years.
#2 competition ahead does not negate, neither will impact and will indeed enhanced the value of Pafase. |
