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FDA, Decode, NIH, Tm Bioscience, Bio-Rad, Ciphergen, Transgenomic

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FDA Extends Herceptin Review for Early Breast Cancer
 
Genentech said last week that the US Food and Drug Administration extended by 90 days its review of the company’s application for expanded use of the breast-cancer drug Herceptin drug to early stage disease.
 
The agency’s deadline for approval or denial of the drug’s additional indication has been moved to Nov. 17 from Aug. 17. If Genentech’s application is approved by the FDA, Herceptin will be an accepted treatment for all stages of breast cancer.
 
The FDA delayed its deadline after it had received additional information related to the submission that it called a “major amendment.”
 

 
Decode Q2 Loss Up 38 Percent on Revenue Decline, Higher R&D Costs
 
Decode Genetics said last week that second-quarter losses widened 38 percent on falling revenue and soaring research and development costs.
 
Receipts for the three months ended June 30 dropped 9 percent to $10.4 million from $11.4 million in the same quarter last year.
 
The company spent about $13.2 million on R&D in the second quarter, up 20 percent from $11 million in the comparable period last year. The increased costs are associated with Decode’s lead drug-discovery and drug-development programs, the firm said in a statement.
 
Decode’s net loss for the second quarter increased to $18 million from $13 million in Q2 2005. The company attributed the loss to higher R&D costs.
 
As of June 30, Decode had approximately $115.5 million in cash and short-term investments.
 

 
…As It Begins Phase I Clinical Trials for Heart-Attack Preventative Compound DG051
 
 
DeCode genetics said this week that it has begun enrolling patients in phase 1 clinical trials for its heart-attack prevention compound DG051.
 
“We are executing on our strategy to target the leukotriene pathway to develop new drugs for the prevention of heart attack,” said Kari Stefansson, CEO of DeCode, in a statement.
 
The compound is a small-molecule inhibitor of leukotriene A4 hydrolase, the protein product of a gene that the company has linked to heart-attack risk.
 

 
NIH Doles Out $21.5M to Help Labs Buy 'High-End' Proteomic, Genomic Tools
 
The National Institutes of Health has set aside $21.5 million for 14 grants to help a number of academic labs buy high-end instruments, including mass spectrometers, sequencers, and supercomputers, the agency said this week. 
  • Stanford University received $543,750 for an ultra-high-throughput genome sequencing system that performs clonal amplification and pyrosequencing to support microbial genome sequencing;
  • The University of California at Santa Barbara and the University of Virginia each received $2 million for an 800-megahertz nuclear magnetic resonance spectrometer. UCSB will study protein interactions with bacteria, and UVA will focus on biopolymers and membrane proteins;
  • The University of California at Los Angeles received $1.2 million for a high-resolution, hybrid Fourier transform ion cyclotron resonance mass spectrometer to study neurodegenerative diseases, respiratory illnesses, and cancer;
  • The University of Maryland in Baltimore County received $1.5 million for a hybrid, 12 Tesla quadrupole/trap-Fourier transform ion cyclotron resonance mass spectrometer to characterize nucleic acids; and
  • The University of Washington received $500,000 for a multi-tiered proteomic compute cluster for protein chemistry studies to study lung injury diseases, toxicity, and drug-induced liver disease.

The one-time awards fund a maximum of $2 million to research institutions purchasing sophisticated instruments as part of biomedical research. The awards will be made through The National Center for Research Resources.

 
Please find information about the NIH's High-End Instrumentation program here.
 

 
Tm Biosciences' Q2 Revenues Climb 55 Percent Though Loss Widens
 
Tm Bioscience this week reported that net losses for the second quarter increased despite a 55-percent surge in revenues.
 
The company reported $3 million in revenues for the quarter ended June 30, up from $2 million during the same quarter a year ago.
 
Product sales for the second quarter climbed 80 percent to $2.9 million from $1.6 million in second quarter of 2005, the company said. It added that sales of Tag-It CF70 reagents and increased demand from Genzyme drove the growth.
 
Tm Bioscience’s R&D expenses for the quarter remained essentially flat at $1.1 million.
 
The company’s quarterly net loss widened 26 percent to $4.6 million from $3.7 million in the year-ago period.
 
As of June 30, Tm Bioscience had $2.8 million in cash, cash equivalents, and short-term investments.
 

 
Bio-Rad to Buy Ciphergen's Proteomics Business for $20M, Takes Equity Stake
 
Bio-Rad Laboratories has agreed to purchase Ciphergen’s proteomics instrument business for approximately $20 million in cash, Ciphergen said this week. Bio-Rad is also making a $3 million equity investment in Ciphergen.
 
Bio-Rad will be acquiring Ciphergen’s proteomics products including its SELDI (surface enhanced laser desorption/ionization) technology, ProteinChip arrays, and accompanying software. Bio-Rad will manufacture, sell, and market the SELDI technology to the life sciences marketplace for applications such as biomarker discovery, characterization, and validation.
 
Ciphergen said that it will retain exclusive rights to the products for the diagnostics market, and that it will maintain a supply agreement with Bio-Rad to purchase SELDI instruments and consumables for the continued development of its diagnostics business. The companies will also collaborate to identify SELDI customers interested in partnering with Ciphergen to commercialize biomarker discoveries, Ciphergen said.
 
Following the transaction, which is expected to be approved by Ciphergen stockholders in the fourth quarter, Ciphergen will have about 40 employees dedicated to commercializing diagnostic tests, primarily in oncology, with an initial focus on ovarian and prostate cancers.
 
Last year, Ciphergen entered a three-year strategic alliance with Quest Diagnostics to develop and commercialize proteomic diagnostic tests, including the first for ovarian cancer. Quest purchased a 17-percent stake in the company as part of the agreement.
 

 
TransgenomicNarrows Q2 Loss 62 Percent Though Revenue Slides 10 Percent
 
Transgenomic last week said that total revenue declined 10 percent in the second quarter and net loss narrowed 62 percent.
 
Receipts for the second quarter ended June 30 slid to $6.2 million from $6.9 million in the same quarter last year.
 
The company spent about $531,000 on R&D in the second quarter, down 9 percent from $581,000 in the comparable period last year.
 
Transgenomic said its net loss shrank to $383,000 from $998,000 in Q2 2005.
 
As of June 30, Transgenomic had approximately $7.4 million in cash and cash equivalents.
 
Looking ahead, Craig Tuttle, Transgenomic’s president and CEO, said in a statement that his “immediate priorities” are to “maximize opportunities from existing products, focus and streamline the product development pipeline, and to accelerate the drive to profitability.”
 
“We are currently looking to commercialize several new products and services that leverage on enhancing the capabilities of our highly sensitive and effective mutation screening technologies,” he said.
 
The first of these is Transgenomic’s Surveyor CE technology, which is designed to reduce the cost and time required for discovering mutations using routine sequencing platforms.
 
The second is a “stronger commercial push” of the company’s lab services business both for research and clinical discovery of disease-causing mutations, he said.
 
The third is based on Transgenomic’s capabilities for isolating DNA from mixed specimens for forensic and microbial analyses. He said the company saw “growing success” in its cytogenetics product portfolio.

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