New companions for new tests
TARRYTOWN, N.Y.—As it continues to strengthen its foothold in the diagnostics field, Siemens Healthcare Diagnostics has established two new companion diagnostics partnerships, one with ViiV Healthcare and one with Tocagen. The two partnerships will target the development of diagnostic tests for HIV and brain cancer respectively, and provide Siemens with a strong boost in the companion diagnostics market.
"Siemens' presence in the emerging companion diagnostics market enables us to leverage our innovation capabilities and deep clinical knowledge to help improve pharmaceutical drug safety and effectiveness," Michael Reitermann, CEO of Siemens Healthcare Diagnostics, said in a press release. "More so, it helps align Siemens with new classes of therapies tailored to the individual that hold the promise of improving patient care and delivering on the goal of personalized medicine."
The partnership with ViiV Healthcare will be centered on clinical trials related to Celsentri/Selzentry (maraviroc), ViiV's novel CCR5 co-receptor antagonist for the treatment of CCR5-tropic HIV. ViiV's Phase III MODERN study will compare Celsentri/Selzentry with Truvada, both in combination with darunavir/ritonavir. The trial will compare the performance of a genotypic test with that of a phenotypic test in identifying patients that would benefit from use of Celsentri/Selzentry, and subject to U.S. Food and Drug Administration (FDA) approval, Siemens might commercialize their genotypic tropism diagnostic test.
"Our partnership with Siemens Healthcare Diagnostics is a valuable part of our commitment to addressing patient needs through developing innovative treatment approaches," Dr. John Pottage, chief scientific and medical officer at ViiV, said in a press release. "Celsentri/Selzentry is an important treatment option for people living with CCR5-tropic HIV and we continue to support the evolution of tropism testing to provide physicians with accurate, accessible and affordable companion diagnostics."
Siemens' partnership with Tocagen will focus on diagnostic tests to support clinical trials related to Tocagen's viral gene therapy, Toca 511 and Toca FC, which are under investigation for the treatment of primary brain cancer. The studies consist of patients with high-grade glioma, such as glioblastoma multiforme. The companies will work together on the assays used in the studies, and pending FDA approval, Siemens may commercialize diagnostic tests that can monitor patient levels of Toca 511 and Toca FC.
"We believe that developing the necessary diagnostic tests with the right diagnostic partner is an important component for the successful commercialization of Toca 511 and Toca FC," Harry E. Gruber, CEO of Tocagen, said in a statement. "Siemens' capabilities in developing commercial viral assays in addition to their market presence in the diagnostics space make them an excellent complement to Tocagen's focus on the development and commercialization of viral gene transfer products to treat advanced cancer."
Trevor Hawkins, CEO of Next Generation Diagnostics at Siemens Healthcare, says the new partnerships fall in line with the company's new initiative, Siemens Agenda 2013, a two-year global initiative. He notes that ViiV and Tocagen are very different in size, which is a bonus for Siemens as it highlights their ability to work with "a broad spectrum of partners."
"Siemens is in a rather unique position here," he adds. "We do not have a pharma division, and so we are able to have the luxury of working both with the established players and the up-and-coming future leaders in this marketplace, such as the Tocagen relationship that we've now established."
Hawkins says he expects companion diagnostics to only become more prevalent as the pharmaceutical industry moves forward, citing "a growing linkage between therapies and required companion diagnostic assays." While companion diagnostics have been particularly common in oncology, as a way to determine patients' responsiveness to therapies, they are gaining popularity for that purpose in other therapeutic fields as well, for patient stratification and to help determine dosing levels. The industry, he says, "is moving towards a model where therapies will need to be tailored more and more to the individual."
"When we think about companion diagnostics, people often think that these are molecular tests, and in many respects they are, but there's also immunoassay tests, there's also imaging that is used as part of companion diagnostics," says Hawkins. "What is exciting from Siemens' perspective is that we have leadership positions in imaging, in diagnostics, in molecular—and we have enabled ourselves to bring together these pieces of the jigsaw puzzle to solve what is quite a complex problem, in terms of being able to give physicians the most up-to-date information on how to make decisions about how they treat their patients.
"We do foresee this area growing, and growing rapidly, and we wholly anticipate future partnership with large and merging pharma partners going forward," he adds.