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Jes Ostergaard of DakoCytomation on Drug-Test Combinations


At A Glance

Name: Jes Ostergaard

Title: President and CEO of DakoCytomation

Background: President and CEO of DAKO A/S — 1999-2002; Managing director, Medicon Valley Academy — 1997-1999; Corporate vice president, Novo Nordisk A/S — 1989-1997; Managing director, Novo BioLabs — 1987-1989

Education: MS in chemical engineering from the Technical University of Denmark — 1972

Age: 56

Astrazeneca’s recent withdrawal of lung-cancer drug Iressa’s application from the European Medicines Agency represents another step down for the compound, which may still be suited to a market of responders defined by a diagnostic. But no diagnostic yet exists that is capable of narrowing a field of patients to only those who would benefit.

Two existing tests — one complementing Herceptin and the other complementing Erbitux — produced by Denmark-based DakoCytomation stand as early examples of the kind of drug-test combinations on which the field of pharmacogenomics is based. Pharmacogenomics Reporter caught up with Jes Ostergaard, Dako’s president and CEO, to discuss those diagnostics, new tests, and the future of the field.

Will you describe the targeted medicine tests that Dako offers?

First of all, we have a Hercept-test that is involved in targeted medicine, and by far the biggest, to our knowledge, and it is a very successful test that goes together with Herceptin. And we have the EGFR [diagnostic].

And also, in case doctors want to measure the DNA part of it, we also have a Her-2 FISH assay, which is being sold in Europe, and which is currently [available] in the US for tests, and is [awaiting] approval by the FDA.

To be clear, we don’t have any claim that we know all and that only immunohistochemistry works. We supply tests that we know work, and we work together with the pharmaceutical companies — in this case [Her-2], we worked together with Genentech and with Roche, and that has been a very successful collaboration for them and for us, and for the patients and the doctors.

Now, of course, things can improve, and in some cases we use — and most doctors today use — as a second step, if there’s doubt, the FISH test to confirm or not confirm. But by far the most used test today is Hercept-test.

And then we have the EGFR, which is out, and is approved to be used with Erbitux. [Jorge Leon, in the previous issue of Pharmacogenomics Reporter] seemed to have misunderstood something, because he was talking about it together with Tarceva and Iressa — and we make no claims that using our EGFR test, we can pick patients for Iressa treatment. And so, it was a bit of a funny statement to make. We know factually that our EGFR test measures epidermal growth factor on the cell surface very reproducibly and very well.

Now, whether the epidermal growth factor on the cell surface is a meaningful thing to measure to give a certain drug, is something that has to be determined through extensive clinical trials, which we, of course, happily work together with the pharmaceutical companies to find out if there is such a relation or not.

In the case of Iressa, not only do we not claim that there is [a link between EGFR test results and response to the drug], we have actually, together with AstraZeneca, made posters that there is no such relationship.

What else do you have that is awaiting FDA approval?

We have collaborations with — if not all — then many of the pharmaceutical and biotech companies with drug candidates in various stages. And some of them we can talk about and some of them we cannot talk about. But we have collaboration with Human Genome Sciences that is still in an early phase. And we have similar things with other companies on which we don’t make any public statements [yet].

There is a lot of talk about pharmacogenomics — or as we call it, pharmacodiagnostics — but the reality is, today it’s a fairly embryonic business, because there are not that many tests that are used commonly to pick out specific patients for treatment. Although we do believe that it has a lot of merit, and it is a part of the business that will grow significantly.

How many diagnostics does Dako have in the pipeline right now?

In the pipeline, in the late stages, there are two or three tests. In early stages, there are probably half a dozen or more. And in the idea stage — if you go and look at the pipeline of the pharmaceutical and biotech companies, there are of course, a thousand drug candidates, and one of the challenges we have is to find the right timing and the right partner, because most of these never become drugs. If we have a test that will be successful, it will need to have a companion drug.

What we do is, we work closely with the pharmaceutical companies to find the right timing to work with them — we believe it helps their development, and if there is a relevant test, it helps their clinical trials. And in our approval situation, they can go to the FDA and get approval because they can point out a meaningful test.

Do you think it possible that a test can resurrect Iressa?

It might well be. Our basic belief is that the better you select the patients to give a drug to, the [greater] are the drug’s chances of success. And I see no reason why we couldn’t find one or more tests that would better stratify patients for treatment with Iressa.

Whether that’s possible or not, I simply don’t know. I think that’s for science and companies such as AstraZeneca and ourselves and other companies to prove or disprove.

Dako’s main methods seem to be immunohis- tochemistry and FISH. Are there any other methods the company is leaning toward for new tests?

Those are the primary methods we are working on right now. We mainly work on tissue, and we also have business in the flow cytometry area, where we sell, develop, and manufacture flow cytometers. But that’s the Cytomation part of the business combined with the Dako side of the business — which was the reagents for the flow cytometry market, and that’s an area that we’re developing, rather than having two separate businesses.

Obviously, if you talk about lymphoma and leukemia, where we have a substantial impact on the reagents side, this is an area where you could also envisage, potentially, pharmacodiagnostic tests. That would also be, initially, antibody-based, but it could also be other technologies.

What do you see as the most promising area for drug-test combinations?

I would think cancer, but I guess I’m somewhat prejudiced because we work primarily in cancer. We consider ourselves largely a cell-based cancer diagnostic company. Cells in flow cytometry or tissue as in immunohistochemistry or FISH.

Do you feel that the problems pharmas are experiencing right now — with cox-2 inhibitors and Iressa, for example — are an opportunity for pharmacogenomics or a liability?

I think there’s going to be a lot of trial and error in this field. It is complex — in some cases it takes large clinical trials to really say something meaningful, because these are complex cause-and-effect relations.

I don’t feel that there is a negative light. I would rather say that one shouldn’t get carried away with some of the hype that is sometimes heard — that everything will be pharmacodiagnostics or pharmacogenetics soon. It’s going to be a long and arduous journey, I think, but I do think it is going to play an increasing role.

Have any of pharma’s recent troubles affected Dako?

No. I would say, if you can turn it the other way around — if we had had an Iressa-EGFR [test combination], we would have of course had a more successful or more positive situation — both AstraZeneca and ourselves. Now, that was not the case, and it was never the case. And we know that you have to kiss many frogs to meet a prince.

That is the nature of the beast, and you have to go into this with open eyes. We don’t expect every time that we work on a new test that we will manage to team it up with successful drug.

And when do you expect Dako to put new diagnostics on the market?

Well, it’s not only ourselves, it’s also the FDA and the pharmaceutical companies. So, we like not to make predictions there — they come when things are ready.

Within the next two years, perhaps?

Yeah, I would certainly be disappointed if we didn’t have new pharmacodiagnostic tests within the next two years, yes.


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