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Dako, Quintiles Partner on Personalized Rx; First Project to Focus on AstraZeneca Cancer Rx

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Dako and Quintiles announced this week that they would work together to develop personalized medicine products, with the first of their projects focused on supporting AstraZeneca's development of an oncology drug.

As part of the non-exclusive alliance, "Dako and Quintiles will offer integrated drug-diagnostic development services and companion diagnostic products," the companies said in a statement. "The first such collaboration will support AstraZeneca in the development of one of its leading oncology compounds."

AstraZeneca has announced several Rx/Dx efforts in recent months.

Earlier this year, AstraZeneca launched its non-small cell lung cancer drug Iressa with companion EGFR mutations testing the UK and in other European countries. Mutation testing in the UK is being offered by DxS and several others. However, AstraZeneca has not announced any plans to launch the drug with a companion test in the US, where it is available under a restricted marketing scheme (PGx Reporter 03/07/10).

AstraZeneca is also working with Myriad to develop companion tests for the PARP inhibitor olaparib it is developing in breast and ovarian cancer (PGx Reporter 06/30/10).

Dako would not discuss the specific cancer drug it is helping AstraZeneca advance as a personalized medicine product. Quintiles did not respond to questions for this article ahead of press time.

Other than Iressa (gefitinib), AstraZeneca also currently markets Arimidex (anastrozole), Casodex (bicalutamide), Faslodex (fulvestrant), Nolvadex (tamoxifen citrate), Hospira (raltitrexed), and Zoladex (goserelin acetate). In Phase III trials AstraZeneca is studying vandetanib, a VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity in medullary thyroid cancer and zibotentan, an endothelin A receptor antagonist in castrate resistant prostate cancer.

In earlier stage trials, AstraZeneca is studying a host of oncologics in solid tumors that inhibit the Chk1 kinase, MEK, MEK/AKT, EGFR tyrosine kinase, erbB kinase, TOR kinase, FGFR tyrosine kinase, EphA2 conjugate, PDGFR-alpha, and IGF. Additionally, the company also is studying an anti-CD22 recombinant immunotoxin and an aurora kinase inhibitor in haematological malignancies; as well as a drug called Recentin which inhibits VEGFR in non-small cell lung cancer.

It's no surprise that Dako is an attractive companion diagnostics partner for drug companies interested in advancing personalized medicine products. Dako, with expertise in tissue-based cancer diagnostics, was the test maker of choice for Genentech when it came to launching simultaneously the breast cancer drug Herceptin with the HercepTest, the first drug/diagnostic combination product.

According to the Dako, it is always looking to partner with drug companies and firms with complementary technologies with the aim of expanding its diagnostics portfolio.

Meanwhile, Quintiles develops genetic tests to gauge cancer cell growth and mutations, and performs these assays at labs in the US, Scotland, and China. Quintiles operates a CAP-accredited central laboratory network, with facilities in the US, Europe, South Africa, India, China, Singapore and Japan, as well as affiliate laboratories in Argentina and Brazil.

Quintiles' international reach is complementary to Dako's expansion strategy, since the diagnostics company also opened subsidiaries in China and Brazil earlier this year.

In June, Quintiles launched a suite of assays targeting the phosphoinositide 3-kinases (PI3K) to support the development of targeted, personalized oncologics. The suite of tests include a PTEN immunohistochemistry and fluorescence in situ hybridization assay, PI3K analysis by FISH, and PI3KCA mutation testing by pyrosequencing and real-time PCR.

Quintiles is also a biopharmaceutical services provider with expertise in providing oncology clinical development services, regulatory advice, commercialization guidance, and reimbursement guidance.

These services will help Dako engage with drug firms in developing companion tests for treatments. Specifically, as Dako develops the tests, Quintiles will provide the clinical trial support necessary to validate the diagnostic in the context of the drug.

The collaboration between the two firms is "designed to help biopharma companies streamline the development of safer, more effective targeted therapies," Dako CEO Lars Holmkvist said in a statement. The alliance between Dako and Quintiles doesn't restrict them from working independently with other drug companies.

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