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Monogram CFO Alf Merriweather on Merck KGaA s Evaluation of eTag with Erbitux


Name: Alfred Merriweather

Position: Chief financial officer of Monogram Biosciences, 2004 — the present

Background: Vice president of finance, chief financial officer, and secretary of Aclara BioSciences, 2001 — 2004 (until merger with ViroLogic)

Education: BA, University of Cambridge, England

Monogram Biosciences, which was known until Sept. 6 as ViroLogic, said this week that Merck KGaA had agreed to evaluate the company's eTag assay for its ability to predict which patients would respond to the drug Erbitux, which Merck markets in Europe.

So far, no one test is considered the best at identifying responders to drugs targeting the EGFR pathway — the closest are the HercepTest by Dako Cytomation and the PathVysion test by Vysis for the drug Herceptin. Monogram has been gradually taking a position on the playing field, recently announcing this, its ninth collaboration with big pharma to evaluate eTag.

Pharmacogenomics Reporter recently caught up with Alf Merriweather, the company's CFO.

What is the size of this study, and what is its purpose?

It's on the order of 50 or so, it's not a big number. This is intended to be an evaluation study, for them to gauge the technology, as opposed to a definitive study per se.

This is the ninth such collaboration that Monogram has been involved in. Is this one more important to Monogram in any way?

I'd say they're all potentially important, because they're all with reasonably significant pharmaceutical or biotechnology companies, so they're all important evaluations conducted, by these companies, of our technology.

Who were the last few collaborations with?

There are some that we've been able to disclose, and some that we haven't. We had one that we disclosed earlier this year, for example, with AstraZeneca.

What will this evaluation of eTag entail?

They're going to be providing us some samples — the objective is to evaluate the technology for its ability to predict patient response, and so they'll be providing some tissue samples from patients who are in one of their European trials. And we will be running our assays and trying to establish some correlations and giving them some information, which they will then correlate with actual patient response, and see how good the correlations turn out to be.

Monogram is going into the evaluation blind, correct?

That's right. Even though it's a retrospective study, it's prospective in the sense that we're blind to the result until we've made the predictions and then can assess how good they were.

They will have assessed for each of the patients whether they responded, and how well they responded.

Will they be taking survival into account, which ultimately halted Iressa's marketing?

They probably will — they will be comparing their definitions of success in the clinical trials. They typically look at both, but there's an increasing emphasis on survival these days.

What does Monogram hope will come out of this study?

Well, two things — we're collaborating with pharmaceutical companies, and we're also doing our own collaborations with clinical folks. Our goal is to launch a commercial product whereby we're providing a test that will enable physicians to assess which patients are going to respond to certain drugs. So, we will be learning how well our tests correlate in the case of Erbitux, and, from their perspective, it will be validation of our technology, clinically, and [it] also holds the potential for a broader relationship.

If they're satisfied with the technology as a predictive tool, then there could be a broader collaboration. And that's frankly our hope with all the nine that we have done — some of them will lead to broader relationships.

Have any of the previous collaborations finished?

Every one of them is either still ongoing, or the specific collaboration has come to an end and we're still in active discussions about further collaborations. Most of them are still ongoing.

Is there any way to characterize the results of those previous projects?

I can't comment on our collaborators, but from our perspective, we look at the correlations that we're seeing as encouraging, in terms of our ability to launch a commercial product during 2006. But we haven't got data that we can publicly put out there right now.

So data gained from these will be used to support the 2006 launch?

I think in a general sense, that's right. Because these are proprietary studies with a customer, they won't necessarily give rise to published, peer-reviewed papers — that will be more the function of our other studies.

Will the eTag be a diagnostic explicitly tied to Erbitux and EGFR drugs?

We're 100-percent focused right now on what we're doing in the EGFR pathway, and the four approved drugs there are Herceptin, Iressa, Tarceva, and Erbitux. So certainly, our product will be focused on that set of drugs. Whether it's specific to particular drugs or a broader panel is still part of the commercial planning that's ongoing. Our plan is to have a commercial product in the EGFR pathway.

How would you roll that out into reference laboratories?

We have our own reference lab here in South San Francisco, and for HIV, for example, we have a direct-sales organization [that] communicates with HIV physicians directly, and we plan to do the same in oncology. We may go through the reference lab, we partnered with them in HIV. We run all the tests here, but the large reference labs do get used for access purposes in certain markets.

When do you expect this current collaboration to finish?

The collaboration itself should be relatively short — certainly a matter of months, not quarters. However, the results will be proprietary to that customer, [so how] the next steps become public will really be dependent on how the collaborator — Merck, in this case — wants to proceed.

Will Monogram ever seek FDA clearance for the eTag assay?

No, because we have a CLIA-certified lab. Our approach to the market right now is to be a reference lab and provide tests in the CLIA format.

Does Monogram see this collaboration as a way to introduce itself and eTag?

Yes. I think all biotech and pharma companies are all focused on the coming trend — if you like — for companion diagnostics for their drugs. And I think they're all trying to evaluate technologies and understand what technologies are available so they can align themselves appropriately.

Over one-third of our business in HIV is from pharmaceutical companies. We have tests we make available to physicians, but side-by-side with that, we are essentially the partner of choice in HIV for drug development for resistance testing. So, we would expect a similar model to develop in oncology, whereupon we're developing and will market tests to aid physicians in their therapy selection. We'd also expect, side-by-side with that, to have relationships with pharmaceutical and biotech companies working with them in their drug-development efforts.

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