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With New Hires to Pharma Business Development Team, Qiagen Prioritizes Rx/Dx Partnership Strategy

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By Turna Ray

Highlighting its desire to ink more Rx/Dx partnerships, Qiagen is expanding its pharma business development team, which it recently established to manage new drug-diagnostic co-development programs with pharmaceutical companies.

"What we're doing is we're prioritizing the pharma segment," Stephen Little, Qiagen's vice president for personalized healthcare, told Pharmacogenomics Reporter this week.

Even though the company is focusing on partnerships with pharma, that "doesn't mean that we're ignoring working with peers or that we aren't considering even doing it ourselves," Little noted, "but certainly, the priority is one, work with pharma; two, work with peers; and three, do-it-yourself."

This week, the company underscored this prioritization by announcing two new hires for the pharma development team: Pia Garguilo and Richard Watts.

Gargiulo comes to Qiagen from AstraZeneca, and will be senior director of pharma business development. Watts, formerly Qiagen's pharma regional marketing manager, will assume a new role as director of the pharma development team. Gargiulo and Watts will join a team that includes Vice President Peter Collins and Senior Director David Jackson. Qiagen noted that the team, based out of Manchester and Crawley in the UK, as well as Dallas and Chicago in the US, has a global reach.

Qiagen already has a foothold in the pharma sector. When it acquired DxS last year, it said it was involved in 15 collaborations with pharmaceutical partners for the development of companion diagnostics to personalized marketed or investigational drugs (PGx Reporter 09-23-09).

Through DxS, Qiagen is working with Bristol-Myers Squibb/ImClone Systems to develop a companion diagnostic test kit for the colorectal cancer drug Erbitux. Similarly, the company is also developing a companion diagnostic for Amgen's colorectal cancer drug Vectibix. The companion tests detecting KRAS mutations will be based on DxS' RT-PCR-based TheraScreen platform (PGx Reporter 09-02-09).

Additionally, DxS has inked two separate agreements to commercialize its TheraScreen EGFR 29-Mutation test kit as companion diagnostics for Boehringer Ingelheim's investigational NSCLC drug BIBW2992 and AstraZeneca's NSCLC drug Iressa. The company also has a worldwide distribution deal with Roche Diagnostics for its TheraScreen KRAS test and TheraScreen EGFR 29-Mutation test (PGx Reporter 06-04-08). It is also developing a companion test for Pfizer's epidermal growth factor receptor-targeting immunotherapeutic in Phase II studies for the treatment of glioblastoma multiforme (PGx Reporter 02-10-10).

"We have the capabilities to be successful in the pharma segment, where you need a lot of depth, a lot of distribution," said Little, who was the co-founder and CEO of DxS before joining Qiagen.

"We think there is a lot of potential to go and expand the whole market, and in particular, to go and expand the pharma segment," Little said, adding that while DxS' expertise lies in developing cancer diagnostics, Qiagen has a focus on infectious disease tests with its existing HPV franchise. Other areas for future diagnostics development could be in the autoimmune space.

In addition there are other areas that the company has identified as diagnostic development opportunities, including drug metabolism enzyme tests, such as 2D6 and 2C9 assays. "Those tests have been around for a long time, and we think there is some decent utility to them," Little said. " I think with the drug metabolism tests, everyone's predicted that something interesting is going to happen with them, and I think their time has come."

According to Little, Qiagen's technology platforms, as well as its development and distribution capabilities, give the company the flexibility to bring diagnostics to market not just through Rx/Dx partnerships with pharma, but also with other collaborators, such as payors, or even on its own.

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In Little's view, the healthcare sector has evolved to accept the concept of pharmacogenomically guided drug development as the way forward. This is evident in the slew of Rx/Dx deals that have been announced since the end of 2009.

Until a few years ago, drug firms gave lip service to the promise of personalized medicine, but had little to show in the way of implementing pharmacogenomics to guide drug development programs. Now, not only are companies such as Merck, Pfizer, BMS, and AstraZeneca advancing investigational drugs with companion tests, but they acknowledge that these aren't one-off products, and that pharmacogenomic analysis is an integrated part of their drug development R&D.

"The thing that's different in personalized medicine this year as opposed to previous years, is that … generally there is an acceptance of how things are and how things are going to be," Little said.

Recalling an illustration he had seen recently, he quipped that there are three stages when introducing a new concept: in the first stage people try to discount the concept as untrue; in the second stage people accept the concept as true but unimportant; and in the third stage people accept the concept as true and important, but maintain that they knew this to be so all along. Genomically guided personalized medicine has undergone this trajectory, in Little's view.

"When we first came out with these ideas 10 years ago there was a lot of resistance to it. Then there was acceptance but not enthusiasm. But now, the idea of using [pharmacogenomic] approaches during drug development is just part of the fabric," he noted.

An even more surprising shift in pharma's acceptance of pharmacogenomics happened when Novartis announced earlier this year that it was planning to relaunch Prexige — a painkiller that was withdrawn from several international markets due to the risk of serious liver damage — with a companion diagnostic that would help doctors exclude patients who will experience adverse events (PGx Reporter 02-10-10).

Prexige, or lumiracoxib, was approved in the EU in 2006, but was withdrawn a year later from most of the 50 countries it was marketed in, including several European countries, Canada, and Australia, following reports of serious liver adverse events and deaths. The drug is currently marketed in a few Latin American and Caribbean countries with risk mitigation strategies.

Novartis submitted lumiracoxib and a safety genetic marker for the management of osteoarthritis pain to the European regulatory authorities in December 2009. The company said that it is discussing its submission strategy for the Rx/Dx product with the US Food and Drug Administration, which deemed Novartis' initial application for lumiracoxib in 2007 "not approvable."

According to Little, Qiagen is watching with interest pharmaceutical companies' increasing willingness to use diagnostics to mitigate safety risks with their products. Qiagen's strengths in HLA genotyping could allow it to partner with companies interested in gauging liver toxicities associated with certain drugs.

"We already have our HLA testing panels. But we have to be careful what we're testing. We can do whole tissue types and then there is doing specific genotypes … That doesn't mean that every drug that has a problem is going to be rescued," Little said. "But what it does mean is that HLA testing will be another type of analysis that drug companies will expect to do in their clinical trials if they get a problem with certain adverse events.

"We're very interested in following [the lumiracoxib] story," Little added. "Even if lumiracoxib doesn't get back to market, it certainly encourages other drug companies to consider the strategy."

Options and Opportunities

While partnerships with drug companies might be a priority for Qiagen, that doesn't mean the company isn't open to using other strategies to bring diagnostics to market.

Little pointed out that for diagnostics firms, the focus of a partnership shifts depending on whether they are collaborating with a drug company to optimize response based on markers or with payors to monitor utilization of the drug. "In working with a pharmaceutical company what you'll be trying to do is bring drugs to market, looking for effectiveness. In working with peers, you'll be wanting to take good drugs and make sure you don't prescribe them unnecessarily," Little explained.

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Since Qiagen's personalized medicine division through DxS is based in the UK, the National Health Service may be a potential partner for the company if the payor gets more involved in forming risk-sharing partnerships with drug and diagnostics firms.

Ahead of a cost-effectiveness appraisal by the UK's National Institute of Health and Clinical Excellence of its non-small cell lung cancer drug Iressa, AstraZeneca is paying for EGFR mutation analysis to help predict which lung cancer patients will benefit from the drug, and providing Iressa through a patient access scheme that charges the NHS a fixed price for each patient treated with the drug (PGx Reporter 04-07-10).

The NHS has announced a handful of risk-sharing schemes with sponsors, including Janssen's Velcade Response Scheme for its multiple myeloma drug; Merck-Serono's cost-sharing program for Erbitux in metastatic colorectal cancer; and Roche's rebate program for its non-small cell lung cancer drug Tarceva.

"I think the NHS are merely receptive" about risk-sharing programs with industry partners, Little said. "They are certainly not taking the initiative at the moment. There are not a lot of risk-sharing partnerships."

However, the fact that that National Institute of Clinical Excellence, the entity that advises the NHS on the cost-effectiveness of medical products, formed a diagnostics advisory committee last year is a sign that perhaps the NHS is increasing its familiarity with Rx/Dx personalized medicine products. "It will be interesting to see what kind of determinations NICE comes out with in terms of not just whether NHS should pay for certain drugs, but whether they should pay for diagnostics," Little said.

Qiagen isn't opposed to partnering with payors in the US, such as Medco, either. The pharmacy benefit manager recently expressed its intention to partner with diagnostics firms interested in launching pharmacogenomic tests without the help of a large pharma. Furthermore, Medco suggested that by helping Dx firms gather clinical utility and cost effectiveness data that could help garner reimbursement and greater utilization for their tests down the road, the PBM can offer a better value proposition to independent test makers (PGx Reporter 04-14-10).

"The payors we work with will be the ones that want to incorporate companion diagnostics into their strategy," Little said. "So, when a company like Medco comes out and makes some encouraging noises, that's encouraging for us, too."

Although the returns for diagnostics firms looking to work with pharma companies to develop companion tests may seem small when compared to drug revenues, Little emphasized that in working with pharma there is value for test makers going forward.

Revenues for typical companion diagnostics are estimated to be between $10 million and $50 million annually, but Little said he believes that there will be "more opportunities and bigger opportunities" down the road. "There is a lot of value in this market, and quite how big it's going to be no one knows."

The value in Rx/Dx partnerships, according to Little, is the combined value of the drug and diagnostic. "The thing you need to figure out is the split" in revenue between the test and the therapeutic, he said. "We'll see how that develops in the next couple of years, but there's a lot of potential in there."

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