Replies to post #90767 on Biotech Values

[turtlepower]

ITMN - IMO you are right that Roche will not want to invest a lot of money on RG7227 based on its safety profile. That ties in with cancelling inform-2 and instead relying on inform-3 which is a a longer duration version of inform-2. From the VRUS PR

"Roche has also announced that it will not conduct the previously planned 28 day INFORM-2 study, designed to evaluate the combination of RG7128 with RG7227, InterMune's HCV protease inhibitor, with and without pegylated interferon and ribavirin. Roche has decided instead to conduct longer duration studies, including the INFORM-3 clinical study of RG7128 and RG7227 with and without pegylated interferon and ribavirin. INFORM-3 will commence after Roche and InterMune identify the optimal dose of ritonavir-boosted RG7227 from ongoing studies. Roche is continuing to conduct dose ranging safety and efficacy studies of RG7227, and has announced a consequent delay of the INFORM-3 clinical study."

So there is less waffling in the language of the VRUS PR. I take the "may" in the ITMN PR to mean that instead of starting in the 2nd half of 2010 the trial could start later depending on when the ideal dose is determined.

Either way its not positive news for ITMN but the news may not be as bad as you make it out to be.

[ghmm]

ITMN:

I would certainly agree on RG7227 boosted + SOC alone likely being dead (at least not going into P3). I think I will wait to see how bad the safety looked in the unboosted study and more importantly what happens with 12 week boosted safety to come to the same conclusion as you... I will concede I am more naive and slower to read the writing on the wall ;-).

I took the may more in reference to study initiation timeline. Given they still haven't announced the 1B boosted study was amended and you add a month or two to enroll (I would guess they do a few cohorts at 12 weeks testing different dosing regimens) and then 12 week treatment time to analyze and initiate a new study I could see how it would easily be pushed back after Q4 '10.

I also didn't read into INFORM-2 as much as you did. Given that unboosted 191 was pronounced dead what would the 4 week study give them? I think they first have to make sure 12 week boosted is safe alone (with SOC).

[ghmm]

ITMN:

If you want a subtle remark from the conference call supporting your contention. Dan Welch was asked about financial guidance (outside of Pirfenidone since they said they will not give that now) he was reluctant to do so saying that could change too. My take was with positive decision on Pirfenidone they would spend more on R&D (in general not just Pirfenidone) so someone skeptical of 191 (Not me yet :-) ) could take that to mean once Roche drops it InterMune gets back full rights and burns their dime pushing it forward.

[mcbio]

Re: Roche/ITMN-191

I think ITMN-191 (a/k/a/ RG7227) is likely dead for all practical purposes. There are enough HCV PI’s in development that it just doesn’t make sense for Roche to invest a lot of money in one whose safety profile is questionable. Ritonavir boosting is not the answer, IMO.

I completely agree. Now, if not ITMN-191, where does Roche turn to for an HCV PI? Do you think there's a legitimate chance that Roche could be considering ACH-1625 given the PoC and the fact that it's about ready for Phase 2?

With respect to the reference that Roche wants to test RG7128 with other non-PIs, what do you think of my speculation in #msg-46762882 that VRUS' PSI-7977 or IDIX's IDX-184, both nukes, could be prime candidates for a Roche partnership? I don't know that there's any clinical data to date to separate the two compounds, although Roche's existing partnership with VRUS could give it an advantage if all things are equal of course.

[go seek]

The deck has been stacked against ITMN-191...

perhaps IDX-184 will fit in here somehow.

>> looked @ a longer term forecast... still a lot of winter left.
Think you may get hit by a big snow storm in early March.

[Biowatch]

Re: HCV Given all the undiagnosed patients, is there a play on a company with a diagnostic test?

Although diagnosis tends to be a less profitable area...

If someone doesn't even know they have a disease, they won't seek treatment.

[DewDiligence]

ITMN/VRUS/Roche: No change re ITMN’s waffling vis-à-vis the INFORM-3 trial in which Roche would test ritonavir-boosted ITMN-191 + VRUS’ RG7128. As before (see #msg-46797334), Dan Welch plainly emphasized the word may on today’s CC when he said INFORM-3 may begin in 2H10.

I continue to question whether Roche will conduct this trial.

[DewDiligence]

ITMN cut its workforce 40% (and did not even bother to issue a PR). Here’s the 8K SEC filing: http://biz.yahoo.com/e/100526/itmn8-k.html .

The layoff does not necessarily signify the demise of ITMN-191 insofar as Roche rather than ITMN is supposedly doing the heavy lifting for this compound. On the other hand, the layoff does not exactly inspire confidence that ITMN-191 remains viable. I posted three months ago that I think ITMN-191 is dead for all practical purposes (#msg-46797334).

[oc631]

For Roche, dropping the program where ITMN-191 was being added to the SoC ought to be a relatively easy decision. The all-oral INFORM-n program is tricky, however: under the terms of the ITMN-191 license, Roche has financial obligations to ITMN if Roche develops any HCV PI, even if ITMN had nothing to do with it. Thus, Roche may try to combine RG7128 (the nuke from VRUS) with an oral drug from a non-PI class, which incurs no obligations to ITMN.

Now that VRUS has suggested a dual nuke combo might be all that's needed in a DAA I'm interested in hearing comments from those who feel that a guanine nuke (PSI-938/661) might/might not be Roche's substitute for ITMN-191. CEO Schaefer Price makes an interesting case for a two drug combo suggesting three drugs are needed in HIV therapy because of lifelong treatment but two complimentary nukes might be enough to eradicate the HCV virus. Does anyone feel the guanine program was started after consultation with Roche or did VRUS act independently? My feeling is we are looking at the next generation of SOC.