Brad,
I am not concern about SmithKline decision to sell IDPH share, and SEC ruling will suspend their decision if it is related to CE9.1 trials (IMO).
I was surprised by, now clear, SK intention to construct two plant! It is normal that when drugs enter P III trials, the future manufacturing site and capacity have to be determined.
Regards the Orlando RA meeting last Oct. I am aware of the all companies and data presented. CE9.1 response rate was ~50% at medium dose. Current P III trials has three dose-regime, six protocols and after initial treatment the contingency will be three additional in 5 months period. It means the remission time in responded patients is ~30-40 days.
As we said in my work (synthetic organic chemistry) it is not how good we are, it is how good or bad are competitors! ISIS 2302 (antisense ICAM-1, anti-inflammatory) was not presented at RA conference. Currently is in P IIa. RA is chronic disease, and life-time therapy is necessary. Monoclonal antibody (humanized or prematized) can trigger (in repeated treatment) antibody response, which can be accumulative during time. This is speculation because there are not enough data to oppose or confirm this. Indicative can be marginal side effects during clinical trials. Rash, at 140 mg dose, was related, according to investigators, to slow absorption of the CE9.1, not to antibody/antigen response. But, there are great real risk that drugs will not be as effective as in the beginning for the longer (several years and longer) therapy-antibody effects. Also CNTO and BGEN are developing anti-CD4 monoclonal antibody for RA. IMO Idec will have serious competitors from this two company, and from IMNX and AMGN which target TNF receptors using monoclonal antibody.
On the other hand, ISIS 2302 solely target ICAM-1, and antisense have fever less side effects and it is synergistic to other treatments. More info on ISIS thread.
Monoclonal antibodies for acute disease therapy have its place in medicine.
My intention is not to trigger discution, but IDPH followers should contribute more for the "in-deep" discussion and valuation of the Idec pipeline, R&D, and prospects.
mz |
