Siemens ($SI) is taking a big step into the hot companion diagnostic arena. The company, which makes a wide range of products, has announced separate pacts with ViiV Healthcare and Tocagen related to HIV and brain cancer, respectively.
ViiV, a company established by GlaxoSmithKline ($GSK) and Pfizer ($PFE), will team up with Siemens on clinical trials for Selzentry--also known as Celsentri--for the treatment of CCR5-tropic HIV. The companies are hoping eventually to commercialize a diagnostic to help guide treatment decisions for individual patients.
ViiV's Phase III MODERN study is evaluating the drug versus Truvada, both in combination with darunavir/ritonavir. It will also be the first large late-stage trial to compare the performance of a genotypic with a phenotypic test in identifying patients for whom Celsentri/Selzentry use is appropriate. Siemens will offer the genotypic tropism testing, while Monogram Biosciences is providing the phenotypic testing.
Meanwhile, the Siemens-Tocagen agreement involves diagnostic tests supporting clinical trials for the latter's experimental viral gene therapy to treat primary brain cancer. The partners hope to commercialize diagnostic tests for therapy monitoring after a regulatory sign-off by the FDA.
Tocagen's CEO Harry Gruber expressed enthusiasm for the partnership with Siemens, saying the partnership will help as it seeks FDA approval for its product. "We realized you really have to have a company that could commercialize as part of your team during the registration studies," Gruber said in an interview with Bloomberg. "We went through a very formal process to interview all the major players in the companion diagnostics space, and from the very beginning, this is the team we jelled with."
Siemens isn't alone in pursuing the companion diagnostics route. Roche's Ventana Medical Systems unit has inked several deals over the past few months, including ones with Bayer Pharma, Pfizer, AEterna Zentaris and Syndax Pharmaceuticals. Abbott Laboratories ($ABT) also has gotten in on the game. Last year, the FDA approved Pfizer's Xalkori (crizotinib) with an Abbott companion diagnostic test to treat certain patients with late-stage, non-small cell lung cancers who express the abnormal anaplastic lymphoma kinase gene.
As Siemens notes in a release, the companion diagnostics market is worth an estimated $1.5 billion annually as the market calls for safer, higher quality drugs.
- see Siemens' release
- check out the Bloomberg story
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