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Loralyn Mears, Dennis Rossi, Lester Crawford, Steven Galson, Janet Woodcock, Qiagen, Stratagene, Beckman Coulter, GE Healthcare, Sequenom, NHGRI, Ciphergen, TGEN, Arizona Univ.


Loralyn Mears has joined Gene Logic as vice president of genomics alliances. Mears most recently led Sun Microsystems' life sciences program as segment manager for life sciences market development. At Gene Logic, Mears will report to Dennis Rossi, senior vice president and general manager of the company's genomics and toxicogenomics business unit. Mears said in an e-mail to BioCommerce Week sister publication BioInform that she will be responsible for "establishing new alliances to broaden Gene Logic's selling and marketing efforts through indirect channels and looking to in-license new and innovative technologies, solutions and products to augment existing genomics offerings."

US Food and Drug Administration Commissioner Lester Crawford has appointed Steven Galson to be director of the FDA's Center for Drug Evaluation and Research, the agency said in a statement last week.

Galson, a rear admiral in the commissioned corps of the US Public Health Service, had most recently served as acting center director, and formerly served as deputy director since he joined the FDA in 2001. Galson holds a BS from Stony Brook University, an MD from the Mt. Sinai School of Medicine, and an MPH from the Harvard School of Public Health.

Galson replaces Janet Woodcock as director of the CDER. Woodcock has been named deputy commissioner for operations and chief operating officer at the FDA, Crawford said.


BioCommerce Briefs

Qiagen Q2 Revenues Rise 2 Percent; Inks RNAi Co-Marketing Pact

Qiagen reported today a slight rise in second-quarter sales and a jump in profit.

The company reported second-quarter sales of $100.4 million, versus $98.6 million a year earlier. Excluding $9.9 million of net sales related to the sale of its synthetic DNA business unit in the second quarter of 2004, consolidated net sales increased 13 percent from $88.7 million in 2004.

R&D costs for the period increased to $9.4 million from $9.3 million year over year.

Qiagen's net income for the quarter climbed 57 percent to $13.8 million, or $.09 per share, compared with $8.8 million, or $.06 per share, in the year-ago quarter.

The firm has been busy over the past several months, acquiring six companies as it aims to build up its proteomics and molecular diagnostic offerings (see this week's Q&A for an interview with Qiagen CEO Peer Schatz).

Qiagen said it had around $157 million cash and equivalents, and $51.8 million in marketable securities as of June 30.

The Dutch firm also said this week that it will co-market its TOM-amidite chemistry-based genome-wide RNAi products with Xantos Biomedicine's automated cell-based screening platform, XantoScreen.

Specific terms of the arrangement were not disclosed.

Stratagene Q2 Revenues Rise 26 Percent

Stratagene this week reported second quarter revenue of $24.9 million, a 26 percent increase over revenue of $19.7 million in the second quarter last year.

According to Joe Sorge, president and CEO of Stratagene, the firm's quantitative PCR products boasted the strongest growth in the life sciences business with sales up 24 percent year over year.

The firm's R&D spending rose slightly to $2.86 million from $2.81 million in the second quarter last year.

Stratagene posted net earnings of $2.1 million, or $.10 per share, for the quarter compared with net income of $1.5 million, or $.08 per share, for the same period last year.

As of June 30, Stratagene had cash, cash equivalents, and marketable securities of $5.7 million. The firm noted that it has repaid roughly $17 million of debt since early 2004, and as of the end of the second quarter its total debt was $4.1 million.

The firm reiterated its full-year revenue guidance of $95 million to $98 million. But, it lowered its earnings per share estimates $.06 to a range of $.33 to $.37 for the full year, due to expenses from patent litigation.

Beckman Coulter Q2 EPS Up on Lower Tax Rate

Beckman Coulter this week announced that its tax rate for the second quarter was 14.6 percent, rather than the 26.2 percent it reported in its July 22 unaudited results. As a result of the lower tax rate, the firm raised its quarterly earnings from $.73 per share to $.85 per share.

Beckman is projecting a full-year 2005 tax rate of 22 percent and has increased its earnings outlook for fiscal 2005 to $2.75 to $3.05 per diluted share. The revised tax rates and earnings per share are the result of the firm's shift in customer leasing policy to more operating-type leases (see BioCommerce Week 7/28/2005).

Beckman said that as income increases from operating-type lease payments it anticipates the company's total tax rate also will increase.

GE Healthcare, Harvard Lab to Develop Software for IN Cell System

GE Healthcare has given an IN Cell 1000 imaging system to Harvard University's Center for Neurodegeneration and Repair, and said it and the university will develop new software applications for the platform, the partners said this week.

The IN Cell systems will primarily be used by HCNR researchers investigating neurodegenerative diseases and the central nervous system using a software package that includes fully validated analysis routines for rapid analysis of a range of biological processes, GE and HCNR said.

HCNR has also been given access to the IN Cell Toolbox to accommodate applications of the system where pre-developed analysis routes are not appropriate.

Additional terms of the partnership were not disclosed.

Sequenom Q2 Revenues Up Slightly, Loss Narrows

Sequenom this week reported a slight increase in second-quarter revenues as losses slid sharply on lower costs.

The company reported a rise in second-quarter revenues to $6.2 million, versus $6 million in the year-ago quarter, an increase the company attributed to both the addition of new customers and the upgrading of the firm's analysis systems by existing customers.

Sequenom's research and development spending dropped to about $3 million in the quarter from $5.7 million a year earlier.

The company posted a net loss of $6 million, or $.15 per share, versus a year-ago loss of $9.8 million, or $.25 per share.

As of June 30, Sequenom had cash, cash equivalents, short-term investments, and restricted cash totaling $25.4 million.

NHGRI Awards $32 Million in New Sequencing Grants

The National Human Genome Research Institute has awarded grants totaling more than $32 million to advance the development of new technologies designed to cut the cost of DNA sequencing and expand the use of genomics in biomedical research and healthcare.

According to the NHGRI, the cost of DNA sequencing has fallen more than 50-fold over the past 10 years. However, it still costs about $10 million to sequence 3 billion base pairs. These grants add to the $38 million the NGHRI issued last October to help pay for the development on newer sequencing technologies.

The NHGRI said it would like to see the cost of sequencing a mammalian-sized genome cut to $100,000 in the near-term. Among the researchers who received grants to achieve this goal are Agencourt Personal Genomics' Gina Costa, who received a commitment of $1.2 million over two years; the State University of New York's Vera Gorfinkle, who received a 2-year grant worth $1.5 million; and Network Biosystems' Greg Kellogg, who received a $4.5 million, 3-year grant.

The NHGRI also awarded numerous grants to researchers looking to cut the cost of sequencing a mammalian-sized genome to $1,000 or less. Among these grant recipients are Duke University's Richard Fair, who was awarded a $510,000, 2-year grant; Reza Ghadiri from the Scripps Research Institute and Oxford University's Hagan Bayley, who received a 5-year grant worth $4.2 million; and Stephen Turner of Nanofluidics, who received a 3-year grant worth $6.6 million.

Ciphergen Restructures, Consolidates Businesses; Heaviest Lay-Offs in R&D, Sales

Ciphergen yesterday confirmed it is restructuring its business, which includes consolidating its two segments and company-wide lay-offs.

The company made the announcement as it reported a 10-percent slide in second-quarter revenue, declining R&D costs, and a 30-percent reduction in net loss.

Ciphergen said it will lay off around 20 percent of its workforce across the company during the fourth quarter. Sales and marketing, which will get the lion's share of the lay-offs, will be cut by 30 percent and represents around half of the current total workforce. R&D, manufacturing, and general and administrative costs will make up the remainder of the downsizing.

Ciphergen said it expects the move to save it around $2 million per quarter beginning in the fourth quarter.

The company said the reorganization is aimed at increasing its play as a biomarker-discovery ally, and said its recent deals with Bayer and Quest will be a catalyst for future growth. To that end, the company has promoted Gail Page, who headed the diagnostic division, to president and chief operating officer.

Ciphergen also said it will continue selling and servicing its SELDI instruments, and will look to generate revenue not only in the volatile pharma space but also in the highly contested academic market. In a conference call with investors and analysts, CEO Bill Rich said he believes the Quest alliance will help generate buzz in the academic market and encourage translational medical scientists to buy platforms.

Though Ciphergen is consolidating its two businesses, both units will continue to play a role in the company, Rich said. The discovery business will focus on biomarker discovery and validation as well as research assay development for collaborators and internal research. This unit will oversee sales and services.

The diagnostic unit, meanwhile, will be responsible for assay development, business development, and all internally funded Biomarker Discovery Center programs, among other things.

Ciphergen has also restructured its customer service department. Its installed base, which comprises 600 customers, will now be overseen by a "centralized after-sale support" approach as opposed to a "non-centralized after-sale service" department." The immediate or foreseeable upshot for existing customers was not immediately clear.

On the earnings front, Ciphergen said second-quarter R&D spending fell to $3.6 million from $5.5 million.

Net losses fell to $9 million, or $.31 per share, from $13.1 million, or $.45 per share, year over year.

The company said it had around $21.3 million in cash and equivalents, and around $2.2 million in short-term investments as of June 30.

TGEN, Arizona Univ. Get Federal Grant for Discovery of Pathogen DNA Signatures

The Translational Genomics Research Institute and Northern Arizona University have won a multi-million dollar grant from the US Department of Health and Human Services to discover DNA signatures of pathogens, the institutions said today.

The multi-year grant will fund several projects. The first study aims to identify pathogen-specific DNA signatures of sepsis and community-acquired pneumonia, which will then be used to develop diagnostic assays for identifying infections based on real-time PCR technology from Applied Biosystems. Laboratory Services of Arizona and the Banner Health System will validate the assays in a clinical laboratory setting.

The Scan

Lung Cancer Response to Checkpoint Inhibitors Reflected in Circulating Tumor DNA

In non-small cell lung cancer patients, researchers find in JCO Precision Oncology that survival benefits after immune checkpoint blockade coincide with a dip in ctDNA levels.

Study Reviews Family, Provider Responses to Rapid Whole-Genome Sequencing Follow-up

Investigators identified in the European Journal of Human Genetics variable follow-up practices after rapid whole-genome sequencing.

BMI-Related Variants Show Age-Related Stability in UK Biobank Participants

Researchers followed body mass index variant stability with genomic structural equation modeling and genome-wide association studies of 40- to 72-year olds in PLOS Genetics.

Genome Sequences Reveal Range Mutations in Induced Pluripotent Stem Cells

Researchers in Nature Genetics detect somatic mutation variation across iPSCs generated from blood or skin fibroblast cell sources, along with selection for BCOR gene mutations.