Replies to post #69750 on Biotech Values

[DewDiligence]

>MRK did say they expect 5 more in pivotal studies by 2012. epo is just first.<

Understood; however, the other four could also be from the “easy” FoB group mentioned in my prior post.

What will separate the men from the boys in the FoB arena are two things, IMO:

• The ability to make complex proteins such as mAbs that are sufficiently close to their branded counterparts to qualify for an abbreviated regulatory pathway.

• The ability to characterize branded drugs completely, allowing fully substitutable biogenerics to be sold with little or no marketing.

It’s unclear to me whether MRK possesses either of these skills.

[DewDiligence]

Re: MRK’s ‘FoB’ program (addendum)

I finally got around to listening to MRK’s entire Dec 9 webcast. My conclusion: analysts and reporters jumped on the FoB bandwagon like Pavlov dogs and didn’t bother to listen to what Peter Kim, head of R&D, actually said.

What Kim actually said is that MRK plans to run a full-fledged clinical program for each of its so-called FoB’s; i.e., MRK does not intend to rely in whole or in part on the clinical data for a reference drug. Sifting through the BS, what this means is that MRK’s so-called FoB program is not about FoB’s at all; rather, it’s about developing biologics based on established MoA’s that exploit GlycoFi’s technology platform.

Biologics are a newfound area of focus for MRK, and this in itself is noteworthy. Moreover, GlycoFi’s platform may be able to produce better and/or cheaper drugs than conventional biopharmaceutical manufacturing. However, for MRK to say that it will use GlycoFi to become a “leader in FoB’s” in closer to propaganda than reality, IMO.

[DewDiligence]

INS-19 (Neupogen) and INS-20 (Neulasta) are included in the five or six biologics MRK says it will have in phase-3 by 2012, according to Reuters. This suggests MRK knew as early as last December that it would be acquiring INSM.

http://www.reuters.com/article/marketsNews/idINN1243354920090212