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Genzyme Official Bemoans PGx 'Media Hype'

A Genzyme official charged that mainstream media outlets have been "whipping everybody up about personalized medicine's promise" and urged the pharmacogenomics community to "be more realistic" about the future of the field.

Robert Yocher, Genzyme's vice president of regulatory affairs, told attendees of IBC's Chips to Hits conference in Boston this week that the idea that a patient could go to a drugstore bearing a chip with his or her biological information on it and receive personalized treatment "is not going to happen in our lifetime or our kids' lifetimes." Yocher spoke during a joint US Food and Drug Administration and industry panel discussion at the conference.

Although he said his optimism about the future of PGx is "tremendous," Yocher said in an interview after his talk that bringing a test to market is a "tough, tough decision" for in vitro diagnostic developers, and that tests in development today would most likely take 10 to 15 years to reach the marketplace, rather than two or three. He noted that the timeline may be shorter for companies trying to bring oncology-focused tests to market.

Yocher placed much of the blame for the promise of a short time to market on "media hype" from "weekly news magazines like Newsweek, as well as trade magazines and newspapers" that create "unrealistic expectations" in the industry and cause, in his opinion, the FDA to "rush" guidance documents to the public. Yocher said he expects the FDA to release "dozens" of new guidance documents over the next decade and said that "what we think is valid now is probably going to change tomorrow."

Yocher also urged the pharmacogenomics community to police its message by writing letters to the editors of publications that "hype" the promise of personalized medicine and to collaborate more effectively to encourage progress in the industry.


Roche and Promega Settle 13-Year-Old PCR Litigation;
Promega to Continue Selling PCR and Taq Products

Roche and Promega have settled their legal battle over PCR-related technologies in the United States, Europe and Australia, Roche said this week.

"All PCR-related litigation resolved to the satisfaction of both parties," the Swiss drug giant said in a statement posted on its web site.

The specific terms of the parties' agreement are confidential, but Roche said that the amount of the settlement is covered by existing litigation provisions in the Roche financial statements.

Randall Dimond, vice president and chief technical officer at Promega, said the company is "very pleased" with the setlement. He added that Promgea will continue to provide the same poroducts and serviuces it has before Roche's suit was launched.

The settlement puts to rest a legal row that began in 1992 when Roche sued Promega in the US District Court for the Northern District of California, for allegedly violating a license agreement and contributing to infringement of Roche's patents for PCR and Taq enzymes.

According to the court documents, Promega had a license to one patent for the Taq enzyme, which allowed the company to sell Taq reagents for other than PCR applications. Promega had obtained the license to this patent, No. 4,889,818, from Cetus, the original holder of the patents to the Taq enzyme and PCR.

In December 1991, Roche acquired all of Cetus' Taq patents. Roche brought suit against Promega the following year, alleging that Promega's sale of "PCR optimized kits" to researchers violated the license agreement to the '818 patent and contributed to infringement on Roche's patents.

In defending against this claim, Promega argued that the '818 patent was obtained through "inequitable conduct," and was therefore unenforceable, the court documents show. In December 1999, the California US District Court ruled that the patent was unenforceable, holding that the applicants to the '818 patent did commit inequitable conduct based on eight misrepresentations and omissions of information about Taq. (This ruling rendered Roche's claims for infringement or breach of the licensing agreement to the patent moot.) Roche then appealed the District Court's decision on the unenforceability of this patent to the US Court of Appeals for the Federal Circuit.

In March 2003, the Appeals Court issued a ruling that ensured the litigation would continue: While it found the applicants to the '818 patent had committed some of the inequitable conduct, it overturned the lower court's finding as to some of the other inequitable conduct, and returned the case to the California District court for a further determination as to whether the patent is unenforceable based on these findings.

In July, Roche was denied a rehearing by a full panel of the appeal's court's judges, returning the case to the lower court, leaving in limbo the issue about the enforceability of the '818 patent-as well as Roche's underlying claim against Promega.


Katrina Forces Reliagene to Leave New Orleans Temporarily

Power-outages triggered by Hurricane Katrina have forced New Orleans-based forensics company Reliagene to move customer samples to a dry temporary facilty and establish a temporary communications facility in Baton Rouge 80 miles away, the company said on its web site last week.

"The short story is that all of our employees are safe," Dave Oehler, Reliagene director of sales and marketing, told Pharmacogenomics Reporter sister publication GenomeWeb News last week. "We found everybody, and everybody is OK."

The company's suburban New Orleans facilities sustained "zero" damage, although other buildings in the same industrial park did not fare as well, Oehler said. "The major problem is that there is no power to the area currently," he said.

Until the company can return to its permanent facility, it will operate through a temporary Baton Rouge communications hub in the facility of the Louisiana Business and Technology Center, a Louisiana State University biotechnology business incubator. "From there we're coordinating all of our customer contacts and shipping of samples and so forth," said Oehler.

"We'll have an announcement soon about how the samples are going to be dealt with in the short term," Oehler said. The firm won't have power or be able to staff its New Orleans lab "for an unforeseen period of time," he said. He added: "It shouldn't be too long.

"In the meantime, we want to be able to have our customer samples run and results returned to them as quickly as possible," said Oehler. "A number" of other accredited US human-identity testing companies have offered to help Reliagene, and the firms are currently drafting agreements to that end, he added.

Oehler declined to name the firms that may be assisting Reliagene.

Reliagene has lost no customer samples, having moved them "under strict chain-of-custody guidelines" to a secure facilty, Oehler said. On Sept. 5, the company "got all of the stuff out of our building that we thought we needed, and set up in Baton Rouge [on Sept. 6], and we went live" Sept. 7, he said.

When asked whether Reliagene's business had sustained any damage, Oehler said, "I don't think there's been any quite yet." The company experienced delays in receiving samples, but expects to continue operating normally, he said. "Certainly there was a delay because it was pretty much chaos here for a week or so, but I think we're bouncing back relatively quickly."


Invitrogen Inks Cancer Biomarker
Deal with Hutchinson Cancer Center

Invitrogen will use its ProtoArray protein microarrays to develop diagnostic and screening tools for cancer under a collaboration with the Fred Hutchinson Cancer Research Center, the partners announced this week.

Invitrogen said it would apply its protein and antibody collections to the collaboration with researchers in the lab of Sam Hanash. The firm will have rights under the multi-year program to license technologies that result from the collaboration. Further terms of the alliance were not disclosed.

This is Invitrogen's second partnership within the past year aimed at discovering cancer biomarkers. The first, signed in December 2004, is with the Mayo Clinic. Under that collaboration, Invitrogen provides financial and research support for multiple biomarker discovery programs at Mayo, and has an option to license and develop resulting technology on an exclusive and non-exclusive basis.


PerkinElmer, Eppendorf to Co-Market
Each Other's Microarray Technology

PerkinElmer and Eppendorf will co-market each other's microarray technology under an alliance announced this week.

The firms said they will jointly promote the use of Eppendorf's DualChip content arrays with PerkinElmer's ScanArray GX microarray analysis system. The firms made the announcement at the Chips to Hits conference currently being held in Boston.

Terms of the partnership were not disclosed.


Correlagen Partners with Children's Hospital
Boston to Clinically Validate Genetic Tests

Correlagen Diagnostics said this week that it has signed a collaborative agreement with Children's Hospital Boston to explore the use of genetic testing in the clinic.

The partners intend to study the "clinical validity" of genetic diagnostics for certain diseases, and to discover correlations between genetic variation and disease phenotypes, the company said.

Correlagen said it will also provide sequence-based diagnostic assays to investigators at Children's Hospital for research purposes.

The company said it has the right to commercialize any diagnostic tests that arise from certain of these research programs.


Expression Analysis Expands Array Service
Contract With EPA; Payday May Increase to $6.7M

The US Environmental Protection Agency has extended and expanded it contract with Expression Analysis to include "additional services and technologies" developed by the company, which will increase the total potential value of the deal to the company by around $4.2 million, the firm said this week.

According to the microarray genetics testing and analysis company, the original contract, for $1.5 million, can be extended for two additional option years at $1.5 million per year for a maximum value of around $4.5 million.

The expanded contract, for $1.6 million, can also be expanded for two years at $2.6 million for the first option year and $2.5 million for the second option year, bringing to around $6.7 million the total potential revenue for Expression Analysis.

The original deal, in which Expression Analysis uses Affymetrix DNA chips, will be updated to enable EPA researchers to access Expression Analysis' statistical tools such as its Reduction of Invariant Probes, Permutation Analysis of Differential Expression, and "other analysis and normalization methods," the company said. The firm will continue to use Affy arrays for the duration of the expanded contract.


VWR International to Distribute
CombiMatrix Microarrays Worldwide

VWR International will distribute microarrays for CombiMatrix, Combi's parent company, Acacia Research, said this week.

Under the agreement, West Chester, Penn.-based VWR will distribute both custom and catalog arrays from CombiMatrix worldwide to pharmaceutical and biotechnology companies, government agencies, and academic institutions, said Mike Tognotti, CombMatrix vice president of sales and marketing, in a statement.

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