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Biotech / Medical : InterMune (nasdaq)ITMN
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To: Biomaven who wrote (116)7/26/2001 8:10:46 PM
From: IRWIN JAMES FRANKEL  Read Replies (1) of 508
 
Hi Peter,

I reviewed the articles. I was an investor in ICN for many years and lived through the period. I saw the HCV market as enormous opportunity for ICN. Bundling was a brilliant move to protect ribavirin from the possibility of generic competition (BRL style) due to some potential weaknesses in their patent estate. It also protected SGP from other interferons being combined with ribavirin. This effectively kept Roche (Roferon) and consensus interferon (Infergen) from penetrating the market. (Only combo was saleable.) Getting doctors to use a compounding pharmacy so that Infergen (rather than Intron A, which had supporting studies) could be used was too much of a hurdle for any significant sales to develope.

Interferon infusion demonstrated that HCV responded better to treatment which maintained a more constant level of interferon. Pegylation provided a means of metering the useable drug levels with once a week delivery, far superior to the clinician.

PEG Intron A approval after a grant of fast track presented a problem for SGP. Since ribavirin (Rebetol) was only available when bundled with Intron A that meant it was not available to combine with PEG Intron A. So they decided to apply for approval of Rebetol independent of Intron A. PEG Intron improved results enough that it was about equal to Rebetron (Intron A + Rebetol). But SGP did not want to lose the revenues on Rebetol and it was synergistic.

So now we find Rebetol is approvable. That should reopen the door to Roche and ITMN. The trouble for ITMN is that both SGP and Roche have a PEG version of their interferon. I think that a PEG version of Infergen was described in the CC today as being "pre-clinical". [Going from memory - I need to check this point.} If the Phase IV data is as good as the comments today suggest - it is essential that ITMN get a PEG version of Infergen into trials. It clearly could become a blockbuster. This could be another serious blow to SGP.

I do think that resistant cases (failed Rebetron) of HCV will be a market for Infergen and that physicians familiar with the drugs will be willing to try combo with Rebetol. This could start even before the Phase IV studies are released and accelerate when the data is distributed.

I hope that we will soon hear more from ITMN about a pegylated version of Infergen.

ij
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