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Pharmas Must Share PGx Outcomes Data In Order for Targeted Medicine to Catch On

SAN FRANCISCO — Drug and diagnostic makers must share more of their outcomes data from pharmacogenomic studies before targeted medicine can catch on more broadly, a health economist said during a plenary session at this year's Beyond Genome conference, held here this week.

A limited supply of data linking pharmacogenomic research with outcomes is one of the key reasons why the discipline hasn't caught on in the way some tool vendors, drug makers, and healthcare providers had expected, Stephanie van Bebber of the University of California, San Francisco, said during her presentation.

In order for targeted medicine to become more widely used — which means widely approved by regulators and reimbursed by insurers — drug makers must "identify and share data" and "continue to move forward through interdisciplinary collaborative models in order that we gain a shared understanding of each other's data needs," she said.

In 2002 van Bebber and colleague Kathryn Phillips, both of whom represent the Program in Pharmacogenomics and Population Screening at UCSF, authored pioneering research that looked at the economics of pharmacogenomics. One paper, published in the December 2004 in Pharmacogenomics, blamed a paucity of economic data studying the cost effectiveness of pharmacogenomics on drug discovery.

These kinds of studies "may help guide the development of drug-diagnostic combinations and speed their adoption in the clinic — and might prove useful to payors seeking lower prices — but there is a relative dearth of them today," Phillips and van Bebber said at the time.

"There are few clinical applications of pharmacogenomics that are currently very widely used," they said. "Until we demonstrate that it could have value, people are going to be reluctant to pursue it."

Perhaps not coincidentally, van Bebber's Beyond Genome talk followed a presentation by Ellen Feigal, director of Medical Devices and Imaging at the Critical Path Institute, who mentioned two recent pharmacogenomic products that were widely lauded when they were released but that quickly flopped and became poster children for the discipline's immaturity: AstraZeneca's lung cancer drug Iressa and Roche's drug-metabolism diagnostic AmpliChip.

Van Bebber, who spoke on behalf of Phillips at Beyond Genome, said another factor contributing to the slow adoption of targeted medicine is the lack of data linking pharmacogenomics methodologies with outcomes. "Economics is not the be-all, end-all," she said.

— Kirell Lakhman, GenomeWeb News editor


NIH Sets Aside $6M for Genomic Technology Development in FY 2007

The US National Institutes of Health has set aside $6 million in funding for the 2007 fiscal year to support technology development related to The Cancer Genome Atlas pilot project that kicked off in late 2005.

The goal of the genomic technology is to "inspire and promote the development of highly innovative tools and new ways to interrogate genomic alterations in cancer, NIH said.

The goal of the genomic technology is to "inspire and promote the development of highly innovative tools and new ways to interrogate genomic alterations in cancer, NIH said.

In a notice issued Friday, titled, "Selection of Funding Opportunities for the Technology Component of the Cancer Genome Atlas (TCGA) Project," NIH outlined three separate funding opportunities under the initiative:

  • Development of Advanced Genomic Characterization Technologies, a program funded under the R21 funding mechanism, for "pilot-exploratory projects using conventional research project grants." NIH has set aside $3 million in 2007 for this program.
  • Development of Advanced Genomic Characterization Technologies, a program funded under the R43/R44 SBIR mechanism, for "exploratory/developmental Small Business Innovation Research (SBIR) funding." NIH has set aside $2 million in 2007 for this program.
  • Development of Advanced Genomic Characterization Technologies, funded under the R41/R42 STTR mechanism, for exploratory/developmental Small Business Technology Transfer (STTR) funding." NIH has set aside $1 million in 2007 for this program.

Clinical Data to Gain $17M in Private Stock Placement

Clinical Data last week said it stands to gain $17 million from the sale of approximately 1.5 million shares and warrants of its common stock to certain undisclosed institutional and other investors.

The company did not discuss when it expects the transactions to close.

Clinical Data President and CEO Drew Fromkin said that the extra capital will strengthen the company's ability to commercialize molecular diagnostics; continue its Phase III clinical development of the antidepressant Vilazodone and help it spin out the vilazodone business into a new company called Precigen Therapeutics; and to enhance its genetic services and analysis business.

The company said it will also use some of the cash to pay for the restructuring it announced in March.


CombiMatrix Molecular Dx, Alpha Innotech to Integrate Tools for CGH Research

Alpha Innotech and CombiMatrix Molecular Diagnostics will integrate certain of their technologies to create a tool for comparative genomic hybridization, the companies said last week.

The deal is centered on Alpha's AlphaScan laser scanner and CMDX's CGH arrays for neonatal screening and biomarker discovery, and calls for CMDX to integrate the AlphaScan scanner into its CGH platform.

CMDX CEO Matt Watson said his firm's customers "are looking for a single integrated platform that will enable them to quickly set up a CGH laboratory and begin running experiments." He said the AlphaScan "represents a key component of that platform."

Financial terms were not disclosed.


Tm Bioscience Hires Distributor to Sell ID-Tag Respiratory Panel in Netherlands

Tm Bioscience last week said that Dutch distributor Sanbio will commercialize its ID-Tag Respiratory Viral Panel in the Netherlands, which is Tm's first deal of its kind in Europe.

The panel detects and discriminates between 20 respiratory viruses including avian flu and SARS, Tm said. Terms of the agreement give Sanbio exclusive right to market and sell the panel in the Netherlands. Tm will supply the distributor with finished packaged product and will receive revenue from the sales.

Tm "intend[s] to complete a series of distribution agreements across Europe over the coming months to be well positioned for the rapid commercialization of this test upon gaining European regulatory clearance, which we anticipate will be achieved in 2006," Tm President and CEO Greg Hines said in a statement.


CombiMatrix to Raise as Much as $50M in Equity Distribution Agreement

CombiMatrix will sell registered shares of its common stock to Cornell Capital Partners at a 2.5-percent discount as part of a standby equity distribution agreement worth up to $50 million, the company said last week.

"This funding structure provides us the flexibility to access additional capital at our discretion," Amit Kumar, CombiMatrix president and CEO, said in a statement. "This commitment will enable us to finance the company for the next two years, during which time we hope to become the leading company in molecular diagnostics."


Strategic Diagnostics Pens Genomic Antibodies Deal With Undisclosed Big Pharma

An undisclosed "top ten" pharmaceutical company has placed an "initial order" with Strategic Diagnostics for its Genomic Antibodies technology, Strategic Diagnostics said last week.

The company said that scientists fro this drug maker "have unsuccessfully attempted to make antibodies to some of the protein targets in this initial order," which they hope to reverse with Genomic Antibodies.

Strategic Diagnostics said this represents the third "major" pharmaceutical customer to initiate a relationship with the company, "and although these represent initially small projects, we are increasingly confident in the commercial viability of this capability."

Strategic Diagnostics' most recent deal before this one was with Berlex in April.

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