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R&D Alliance Between FDA, NCI, and CMS to Focus on Cancer Biomarkers, PGx; Industry Could Play Role, Clinical Data,

The US Food and Drug Administration, the National Cancer Institute, and the Centers for Medicare and Medicaid have created a new Oncology Biomarker Qualification Initiative with an aim of using biomarkers, including genomic and proteomic markers, to help develop drugs and diagnostics, the agencies announced this week.

Specific areas of scientific activities include the application of platform technologies for assessing genomic and proteomic alterations, multiplexed molecular assays, and advanced imaging modalities.

As part of the alliance, NCI "seeks to develop technologies to improve the detection, diagnosis, treatment, and prevention of cancer;" FDA "is interested in exploring biomarker technologies as assessment tools for use in FDA guidance to facilitate cancer drug development;" and CMS "is interested in the development of evidence to inform reimbursement decisions making about existing or new treatment regimens."

"The goal of OBQI is to validate particular biomarkers so that they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients," the partners said in a statement.

The first OBQI project will study FDG-PET imaging as a predictor of tumor response in patients with non-Hodgkin's lymphoma.

Under the agreement, the three agencies will collaborate to "develop strategic plans, set priorities and leverage resources, including the private sector, toward the goal of improving the clinical utility of biomarker technology," according to a memo released by NCI.

OBQI will continue to develop public resources, including databases and lab specimens, and seek input from private sector partners through direct research or funding, the NCI said.

Details about the length and funding of the initiative were not immediately available.


Third Wave, Innogenetics Settle Patent Suit

Third Wave and Innogenetics have settled a patent-infringement suit Innogenetics filed against Third Wave last September, the companies said last week.

Under the agreement, Third Wave will get a non-exclusive license to sell Innogenetics hepatitis C genotyping products and the option to extend the license to the entire HCV patent estate.

"We are particularly happy to have concluded this licensing agreement. The amicable resolution of this issue will help both companies realize their ambitious near- and mid-term goals," said Innogenetics CEO Frank Morich.

Financial details were not disclosed.

Last September, Innogenetics sued Third Wave Technologies and Abbott Laboratories for allegedly infringing its HCV genotyping patents. The disposition of the Abbott suit was not immediately clear.

In the suits, filed with the US District Court for the Western District of Wisconsin, Gent, Belgium-based Innogenetics claimed that both Abbott and Third Wave have been infringing its US Patent No. 5,846,704, which covers a process for typing HCV isolates. Both companies have refused to take a license to the technology, according to Innogenetics. The company said it expects a ruling within 12 months.

Third Wave and Innogenetics have been partners since at least April 2004, when the two companies signed a four-year marketing and distribution agreement, under which Innogenetics distributes a number of Third Wave's Invader molecular diagnostic products exclusively in Europe.


Acquisitions Help Clinical Data Post 39-Percent Revenue Growth in Fiscal Q3

Clinical Data posted a 39-percent surge in revenues during its fiscal third quarter due to an increased asset base from the acquisitions of Genaissance, Icoria, and Electa Lab, the company said this week.

Revenues for the three months ended Dec. 31, 2005, increased to $19.9 million from $14.3 million in the year-ago period.

The company reported a net loss for the third quarter of $42.8 million, compared with a net income of $1 million in Q3 2004. Specifically, it recognized $40.1 million in aggregate purchased in-process R&D expenses related to the development of biomarkers for vilazodone and clozapine, two of the leading products in development acquired with Genaissance.


Gen-Probe, CPDR Pen Three-Year R&D Alliance to Develop Prostate Cancer Dx

Gen-Probe is funding a three-year study at the Center for Prostate Disease Research aimed at developing a new diagnostic test for prostate cancer, according to the Henry M. Jackson Foundation, which manages CPDR programs.

Under the deal, Gen-Probe will get a non-exclusive license to develop and commercialize the resulting test, the foundation said in a statement released this week.

Financial details were not provided.

CPDR is currently trying to asses the clinical utility of expression alterations of a novel prostate-specific gene, PCGEM1, and the ETS-related gene, ERG, in prostate patients.

"The primary goal of the initiative is to create a new generation of highly specific gene panels in urine. ... This work could complement or significantly improve the currest PSA blood test, which suffers from lack of specificity," said CPDR co-director Shiv Srivastava, who will lead the studies with Harry Rittenhouse, Gen-Probe senior director of cancer research.

Under the agreement, CPDR's oncogenes may be studied in combination with other prostate cancer markers owned by Gen-Probe, including PCA3 and AMACR.

The CPDR was established in 1991 through a collaboration between the Uniformed Services University of the Health Sciences and the Henry M. Jackson Foundation. The USU-HJF have jointly filed several patent applications on the unique use of the combined panel of genes as well as on new genes discovered by CPDR.


Genmab Licenses Angiogenesis Targets from Bionomics

Genmab said this week that it has licensed exclusive worldwide rights to develop therapeutics based upon a series of angiogenesis targets identified by Bionomics.

Under the agreement, Copenhagen, Denmark-based Genmab has acquired the rights to eight proteins identified and characterized by Bionomics using its Angene angiogenesis platform.

Bionomics will receive an upfront fee and additional fees upon the completion of preclinical and clinical milestones, the companies said. Bionomics will also receive milestone payments and royalties on product sales.


NCI Launches $14M Breast and Prostate Cancer Initiative; Illumina to Do Genotyping

The National Cancer Institute launched an initiative to identify genetic susceptibilities to prostate and breast cancer, the National Institutes of Health announced this week.

Illumina has been tapped to do rapid genotyping for the project, NIH said, beginning with 2,500 male samples for the prostate cancer portion of the research.

The Cancer Genetic Markers of Susceptibility project is a three-year initiative with $14 million in funding, according to a statement.

The initiative will analyze as many as 500,000 SNPs in each cancer case or control. NCI's Division of Cancer Epidemiology, Core Genotyping Facility, and Office of Cancer Genomics will coordinate the project.

CGEMS data will be available via NCI's caBIG project.


TM Bioscience to Supply Tag-It CF Assays for St. Joseph's Hospital, Montreal Children's Hospital

TM Bioscience will supply St. Joseph's Hospital and Montreal Children's Hospital with Tag-It reagents for use in its cystic fibrosis testing program, the company said this week.

Financial details were not disclosed for either agreement.


Roche, ABI Settle PCR Patent-Infringement Suit Against Bio-Rad

Roche Molecular Diagnostics and Applied Biosystems have settled their PCR-based lawsuit with MJ Research, the companies said this week.

Under the settlement, Bio-Rad, which acquired MJ Research in 2004, will make an undisclosed payment to Roche Diagnostics and ABI to settle all outstanding patent-infringement claims.

Applera and Roche Molecular Systems sued MJ Research in the US District Court for the District of Connecticut in June 1998. A jury decided in favor of Applera and Roche in 2004. Bio-Rad acquired MJ in August of that year.

In September, Applera announced that the court had issued a permanent injunction prohibiting Bio-Rad from manufacturing, selling, or servicing infringing thermal cycler products in the US — despite Bio-Rad's claim that the companies had settled the suit on Aug. 29.

Two months later, the court denied a motion from MJ to "enforce" the settlement agreement, and Bio-Rad said that it planned to appeal the court's decision.

Roche Diagnostics and ABI said this week that the court rejected all challenges to the enforceability of Roche's PCR patents and its licensing program.


Transgenomic Grants NorDiag Exclusive European WAVE Rights

Transgenomic and NorDiag announced last week that they have signed an exclusive license and supply agreement to collaborate in colorectal and pancreatic cancer diagnostics.

Terms of the deal call for Transgenomic to give NorDiag exclusive European commercial rights to use its Wave system in exchange for an undisclosed licensing fee and commitment to annual purchases by NorDiag.

NorDiag uses the Wave system in its Genefec test. The platform is "integral to the automation of the Genefec test," said the companies in a statement.

NorDiag has offices in London and Bergen, Norway. The Genefec test is available as a clinical diagnostic in Norway and Sweden.

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