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Enzo, Epigenomics, Affymetrix, Nexavar, FDA, CombiMatrix, Third Wave, TGen, Mount Sinai, Genizon, Illumina, ReaMetrix

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Enzo Views Court Ruling as Favorable, But Defendants Disagree
 
A US District Court earlier this month settled the interpretations of eight patents at the heart of a 4-year-old lawsuit pitting Enzo Biochem against defendants GE Healthcare, Affymetrix, PerkinElmer, Sigma Aldrich, Orchid Biosciences, Molecular Probes, and Roche.
 
Since it first filed the suits in 2002 and 2003, Enzo has alleged that the defendants, by selling its reagent kits improperly, are infringing 15 claims of eight different patents. The parties participated in a Markman hearing to define the interpretations of those claims in July 2005.
 
In the order, handed down July 10, Judge John Sprizzo of the US District Court in the Southern District of New York ruled that Enzo could indeed proceed with its litigation against the seven biotech firms. However, Sprizzo rejected many of Enzo’s interpretations of the eight patents, causing both Enzo and one of its opponents to claim a victory.
 
Enzo issued a statement last week arguing that “the ruling supports Enzo’s position that hundreds of defendants’ products infringe certain Enzo patents” and “opens the door for Enzo to not only pursue its patent infringement claims, but, as importantly, to also aggressively pursue its claims that defendants breached their contractual obligations to Enzo.”  
 
A person familiar with Enzo’s position who wished to remain anonymous because he didn’t want to comment on ongoing litigation told Pharmacogenomic Reporter’s sister publication BioArray News this week that, although the court constructed many of the claims in a manner that could be seen as favorable to Enzo’s opponents, Enzo sees the ruling as positive to itself. The source said this is particularly the case because the ruling left mostly intact a key patent in the suit, US Patent No. 4,994,373, entitled “Method and structures employing chemically-labelled polynucleotide probes.”
 
Enzo officials could not be reached for comment. But a couple of defendants in the case disagreed with Enzo’s assessment of the ruling.
 
“Among its allegations, Enzo contends that Roche's AmpliChip CYP450 Test infringes Enzo's US Patent No. 4,994,373. However, Judge Sprizzo's order rejected Enzo's interpretations of both the testing format and the ‘soluble signal’ claimed by this patent, and instead agreed with interpretations by Roche Diagnostics and its co-parties,” Roche said in a statement released soon after Enzo‘s announcement.
 
“The Court adopted virtually all of the interpretations proposed by Roche Diagnostics and its co-parties relating to seven Enzo patents covered by the order,” the firm added.  
 
PerkinElmer also took issue with Enzo’s statement. In an e-mail to BioCommerce Week, a Pharmacogenomics Reporter sister publication, the company said, “We are pleased with the court’s decision, which favored us on every major issue. We note that Enzo has already released a press release which, while not technically incorrect, seemingly portrays the decision in favor of Enzo. However, the decision actually rejected many of Enzo’s claim constructions.”
 
Epigenomics Pays Affymetrix $2M in Stock as Part of Dx Deal
 
Epigenomics last week paid Affymetrix €1.6 million ($2 million) worth of stock as part of the upfront payments the firms agreed to under a diagnostic alliance announced in June, the company said last week.
 
As part of the deal, Epigenomics issued 304,791 novel non par value bearer shares valued at €5.22 each. After registration, the value of Epigenomics' outstanding common shares will increase to €16.7 million from €16.4 million.
 
Nexavar Approved for Renal Cell Cancer in Europe
 
The European Commission this week granted marketing approval to Nexavar, a product of Bayer Pharmaceuticals and Onyx Pharmaceuticals, for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon alpha or interleukin-2 therapy, the companies said in a statement.
 
The decision followed a positive opinion from the European Medicines Agency Committee on Medicinal Products for Human Use in April, as well as the US Food and Drug Administration’s approval of the drug in renal cancer in December.
 
Approximately 200,000 people around the world are diagnosed with kidney cancer each year, the companies said.
 
FDA Wants to Talk With CombiMatrix About Its Constitutional Genetic Array Test …
 
CombiMatrix said this week that the US Food and Drug Administration's Office of In Vitro Diagnostic Device Evaluation and Safety has asked to speak with it about its Constitutional Genetic Array Test.
 
CombiMatrix said the FDA wants to discuss the company's plans to market [the] CGAT in September. CombiMatrix said that it plans to meet with the FDA in the “near future.”
 
Last month CombiMatrix Molecular Diagnostics said it will launch its first molecular diagnostic service in the US in August. The service will use the CGAT, which “can genetically identify more than 50 common genetic disorders,” including developmental disorders. The service is already sold in Europe through Paris-based Array Genomics.
 
CMDX said it's in the "final phases" of internal human and clinical validation. In March, CMDX and Array Genomics said they will co-develop and co-market a series of comparative genomic hybridization microarrays for diagnosing genetic anomalies associated with mental retardation, a developmental disorder.
 
Matt Watson, CEO of CMDX, said in June that the firm is "actively developing further tests based on both our oligo and BAC capabilities that augment our microarray portfolio and over the next three quarters, we have plans to launch three to five additional products into the molecular diagnostics market."
 
… as Wind-down of Government Contracts Causes Q2 Revenues to Decline
 
CombiMatrix last week said that second-quarter revenue declined 3.5 percent as R&D spending doubled and net losses narrowed slightly.
 
Total receipts for the three months ended June 30 declined to $1.79 million from $1.85 million in the year-ago period.
 
Year over year, revenue from government contracts fell 55 percent to $574,000 from $1.3 million. Revenues from product sales more than doubled to $1.2 million from $567,000 and service contracts quintupled to $60,000 from $9,000, the company said.
 
CombiMatrix excused the drop in government contracts by saying that the second quarter of 2005 had an "anomalously high level of activity" under its Department of Defense biological threat detection contract.
 
The Acacia unit said net losses shrank slightly to $3.4 million versus $3.7 million in the year-ago period. The current quarter's loss included non-cash stock compensation, patent amortization, and depreciation charges totaling $971,000 versus $541,000 in the comparable 2005 period.
 
R&D spending in the period increased to $2.2 million from $1.2 million year over year. This increase was due "primarily" to developments ongoing at the CombiMatrix Molecular Diagnostics division.
 
CombiMatrix reported $10 million in cash, cash equivalents, and short-term investments as of June 30.
 
Third Wave's Q2 Revenues Increase 17 Percent As Losses Narrow
 
Third Wave Technologies said this week that revenues for the second quarter increased approximately 17 percent, including an 18-percent spike in clinical molecular diagnostic receipts, as net losses declined.
 
Third Wave said revenue for the three months ended June 30 increased to $6.8 million from $5.8 million year over year. The company reported $5.1 million in clinical molecular diagnostic revenues and $1.6 million in research revenues.
 
Net loss for the second quarter declined to $4.7 million from $5.5 million in the same quarter one year ago.
 
R&D spending in the period increased to about $3 million from $2 million in the year-ago period.
 
As of June 30, Third Wave had $36.2 million in cash, cash equivalents, and short-term investments.
 
In addition, Third Wave said it would launch its Universal Invader Plus program earlier than anticipated as customer evaluations have progressed well.
 
Arizona Gives TGen $7.1M to Develop Early Dx for Autism
 
The Arizona State Legislature has appropriated $7.1 million to the Translational Genomics Research Institute to help it research autism and develop tests for the condition, the company said this week.
 
The research, a joint collaboration between TGen and the Southwest Autism Research & Resource Center, will aim to develop an early diagnostic kit to identify children who are at risk for autism, and to identify the type of autism.
 
TGen will also use the money to secure future funding for a $50 million Arizona Autism Research Initiative. The initiative's aim will be to develop diagnostics and medicines.
 
Mount Sinai to Use JPT Peptide Arrays in Food Allergy Biomarker Collaboration
 
JPT Peptide Technologies, a subsidiary of Berlin-based pharmaceutical company Jerini, said this week that Mount Sinai School of Medicine will use its PepStar peptide-microarray platform as part of a biomarker discovery collaboration.
 
JPT and MSSM will use the peptide arrays to discover B-cell epitopes for use in developing vaccines and diagnostics in the field of food allergies.
 
Researchers at MSSM will use the arrays to study samples of “diverse patient populations suffering from various kinds of food allergies,” the company said in a statement.
 
JPT will use its peptide synthesis and screening platform to generate large numbers of peptides derived from food allergens, which will be used to produce identical copies of peptide microarrays for incubation with patient samples.
 
"Our experience has shown the use of peptide microarrays to be a highly efficient and cost-effective tool for the systematic screening of the B-cell response of complex patient populations,” said Hugh Sampson, director of the Jaffe Food Allergy Institute at MSSM, in a statement. “In this context, JPT's platform is unique in both its synthesis power for tens of thousands of peptides and its suitability for resulting microarrays for the purpose of biomarker identification by means of patient sera."
 
Genizon Begins Offering SNP-Genotyping Services on Illumina Technology
 
Genizon BioSciences last week said it has begun providing SNP-genotyping and statistical-analysis services.
 
Genizon performs genotyping with eight Illumina BeadArray instruments, custom Illumina Infinium chips, and GoldenGate marker sets.
 
The company also performs genetic analysis with its own platform, GeneSys. The system is capable of genotyping as many as 100 million genotypes per day.
 
All services will be performed at Genizon's Montreal-based GLP-compliant facilities.
 
Illumina, ReaMetrix to Develop Dx Panels Based on BeadXpress Platform
 
Illumina and ReaMetrix plan to develop molecular diagnostic panels for several diseases, the companies said last week.
 
The panels will "help predict the risk of disease, enable earlier intervention, and guide therapy," Jay Flatley, Illumina president and CEO, said in a statement.
 
Terms of the agreement call for Illumina to supply its VeraCode technology and other reagents while ReaMetrix will develop, validate, and market the panels.
 
The panels will be based on Illumina's yet-to-be-released BeadXpress platform, which the company plans to launch before the end of the year.
 
As part of the deal, ReaMetrix will gain non-exclusive rights to market the products in India while Illumina will be allowed to market the tests elsewhere in the world.
 
ReaMetrix will drive market development activities from its Bangalore, India, operation, the companies said.
 
Financial details were not disclosed.

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