Monday, November 17, 2008

Wolf: An Eye-Witness Report from San Francisco AASLD on "Those Hep C Races". . . .


UPDATED @ 2 PM EST: "Investors have been paranoid about telaprevir competition, but at this year's meeting, I think we saw that there doesn't appear to be anything more potent than telaprevir, and we still need to see a lot more data on safety [re competitors' candidates]. . . ." Cowen & Co. biotech analyst Rachel McMinn told Adam Feuerstein, in a phone conversation after AASLD.

Cowen has an "outperform" rating on Vertex.

So, it would seem Cowen & Co. agrees with Wolf's take, here.

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This (Thanks, yet again, "Wolf"!) was left in the comments, below -- and deserves to be read widely -- it is a first-hand account of the Telaprevir (Vertex's) v. Boceprevir (Schering-Plough's) presentations/posters, at the big liver meeting last week, in the City by the Bay:
. . . .Last week, I returned from the San Francisco AASLD liver meeting where I had the opportunity to review first hand both the SP boceprevir and the Vertex telaprevir data.

Vertex was the clear meeting winner presenting ground-breaking evidence of telaprevir efficacy in previous treatment non-responders, the #1 unmet clinical need in hep C. With only 50% of patients responding to current therapy, a status quo that has existed for approximately 10 years, the telaprevir non-responder data opens up a huge market of already identified patients that did not respond to current therapy.

The comparative significance of the data was not lost on AASLD organizers as they chose to award an oral presentation to Vertex whereas the SP data was buried in a poster session despite the "buzz" they were attempting to generate.


[Editor's Note: Older Graphic of Stock Price
Comparisons -- this morning, SP is @ $15.35; while
Vertex is trading at $27.37. . . .]


The SP data from my perspective was "ho hum" at best. Although showing an outwardly impressive response rate in naive patients, the patient population was arguably an "easier to treat population" with a very low proportion of patients with advanced liver disease (less than 10% cirrhotic). The claim that induction dosing was providing superior response was met with dubious reaction of many liver specialists as the concept of induction dosing has been "dead" for a number of years with many trials failing to show a benefit of this therapeutic approach.

The big commercial issue for SP in my mind is that all of the data they have presented demonstrates benefit with 48 WEEKS treatment, whereas telaprevir has been shown to be effective in the same naive population with half the duration of therapy, i.e., 24 WEEKS. This is not insignificant as these molecules must be administered in combination with peginterferon injections, a therapy which is extremely difficult to tolerate (think flu, fever, hair loss, rash, tremors, depression, bone marrow toxicity, suicidal ideation etc.). With similar response rates, specialists and patients (not to mention payers) would choose a 24 week therapy compared to a 48 week therapy ever time. This presents a huge problem for SP as they will likely enter market after telaprevir is established with at best a "me-too" treatment that requires double the duration of therapy.



[For the Curious: What the above is all about.]


I am also bewildered by the SP choice to only develop bocepevir in combination with their brand of peginterferon ie. PEG-INTRON which currently holds about 35% of world share vs 65% PEGASYS (Roche). Vertex is developing telaprevir with PEGASYS. Why SP would choose to pair themselves with the market loser either demonstrates arrogance or extreme stupidity. Not only is their interferon market failing, they are likely to drag boceprevir down with it.

Perhaps the same SP strategists that worked on the release of the ENHANCE study data have now picked up boceprevir?

-- Wolf

November 17, 2008 12:02 AM

Indeed -- so it would seem, Wolf. Thanks for this. Coffee is on me -- in Philly -- if you are going to be there. . . .

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