Replies to post #127911 on Biotech Values

[NP1986]

I believe AEZS managed to get a European patent for the perifosine-capecitabine combo valid till 2021, IIRC. No news from KERX regarding the status of the patent application in the US.

Good point about the phase 3 study possibly enrolling more patients in later lines. In the phase 2 study, most patients were 3rd line patients. X-PECT will possibly have a greater proportion of 4th line patients, depending on how many KRAS wild type patients enrol in the study.

As to what the better play is, I'm not sure. AEZS does have a deeper pipeline, so there is some downside protection although not a whole lot IMO. Their other phase 3 product is not expected to generate more than 25m in sales per year. AEZS-108 might have an opportunity in gynecological cancers, but unless it demonstrates superior efficacy to doxorubicin, I think its commercial upside will be limited. It has a better toxicity profile, but I don't think that alone will be sufficient to command a high premium over doxorubicin.

KERX has stated that they would be looking for potential buyers if X-PECT succeeds. I don't know if that makes it a better or worse short term jnvestment.

[iwfal]

KERX AEZS - Something kinda odd went on with the ph ii trial, at least with regards to what shows up on clinicaltrials.org:

1) The trial actually closed enrollment after enrolling multiple cancer types and allowing co-administered drugs of many types for about 2 years. (6 cancer types and thus 6 potential co-drugs)

2) AEZS Investor status gives status on PR/CR/ORR in Aug 2009 for 35 randomized patients per +/- cap.

3) In Sept 2009 it re-opens the trial to "enrollment by invitation" of only CRC patients

But the recently published data doesn't meaningfully expand the number of patients - what happened to the invited patients, or was it only 3 invitees (the latest paper, pointed to by genisi, had 38 patients)?

PS No discussion that I can find is ever made by the companies of the efficacy in the rest of the randomized ph ii (300 patients). So it can be presumed that they were all a complete bust. BUT, on the bright side, even if you adjust the p values for all of those failures the p values are still pretty good (especially in CRC PFS).