Skip to main content
Premium Trial:

Request an Annual Quote

Biocon, Warnex, PRO-DNA, Third Wave, Applera, ABI, FDA, Affy, CombiMatrix, Geneservice


India-based Biocon Files for EGFR Drug Approval from India Regulators

Biocon said last week that it intended to file for regulatory approval of its EGFR-targeting drug Biomab from the government of India in May, with possible approval by the end of the year. The company made no mention of pharmacogenomic uses of the monoclonal antibody compound, although there is evidence that response to EGFR inhibitors can be associated with genetic or protein biomarkers.

India-based Biocon subsidiary Biocon Biopharmaceuticals recently finished clinical trials for the head-and-neck anticancer compound. Biocon Biopharmaceuticals is a joint project with the Cuba-based Center for Molecular Immunology, or CIMAB. The organizations will market the drug in India and South Asia, and CIMAB has a supply arrangement for marketing it in the United States.

Biocon Biopharmaceuticals last week also inaugurated a facility to produce Biomab, which will be the first proprietary drug for Biocon, which generally manufactures generics.

CIMAB is also developing the drug with partners in Germany and China.

Warnex to Acquire Genetic Testing Firm PRO-DNA for $2M

Canadian firm Warnex said this week that it has agreed in principle to acquire genetic-testing service provider PRO-DNA Diagnostic for $2 million.

The purchase price is divided into $1.2 million in cash, approximately $200,000 to $300,000 in working capital adjustments, and $500,000 payable in common shares of Warnex, the company said.

"The acquisition of PRO-DNA will mark our entry into the field of human genetics testing and pharmacogenomics," Mark Busgang, president and CEO of Warnex, said in a statement.

PRO-DNA had $870,000 in revenues in its last fiscal year and is expected to be immediately accretive to earnings, Warnex said. It will operate as a division of Warnex Medical Laboratories and will be relocated from Montreal to the Warnex facilities in Laval, Quebec.

Third Wave's Q1 Revenue Rises 11 Percent as R&D Slides; Loss Unchanged

Third Wave this week said first-quarter revenues increased 11.3 percent as R&D spending dipped slightly and net losses remained roughly flat.

Total receipts for the three months ended March 31 increased to $7.9 million from $7.1 million year over year. Revenue from clinical product sales grew 52 percent to $4.7 million, though revenue from research products fell 21 percent to $3 million.

License and royalty receipts fell 71 percent to $27,000, while revenue from grants increased 19 percent to $142,000.

Third Wave said R&D spending in the quarter declined 8 percent to $2.3 million from the year-ago period.

Net loss remained flat at $4.4 million, or $.11 per share, the company said.

Third Wave said it had around $35.6 million in cash, equivalents, and short-term investments as of March 31.

Applera Declares ABI Dividend

Applera said this week that its board has declared a regular quarterly dividend of $0.0425 per share of the company's Applied Biosystems subsidiary.

The dividend is payable on July 3 to shareholders of record as of June 1.

FDA Seeks Microarray Datasets for Quality Control Project

The US Food and Drug Administration is soliciting gene expression datasets from microarray experiments as part of its MicroArray Quality Control project.

In a notice of solicitation dated April 13 and posted on the FDA website (pdf) last week, FDA said that it is seeking datasets "as well as proposals to analyze these datasets in order to evaluate the impact of different analysis protocols on the selection of genes and their associated signatures for biomarker pattern development."

The FDA's National Center for Toxicological Research is collecting the datasets and proposals for participation in the project. The evaluation process is open to the public, FDA said.

The MAQC project involves six FDA centers, several microarray vendors, government agencies, and academic labs that are working to develop "baseline practices for the analysis of hybridization data," the FDA said.

Further information on the MAQC project is available here.

Affy's Q1 Sales Sink 10 Percent as Profit Dwindles; Shares Fall Below 52-Week Low

Affymetrix last week said that first-quarter sales declined more than 10 percent as overall revenue fell 2.5 percent year over year amid growing R&D expenses and shrunken profits.

Sales for the three months ended March 31 fell to $66 million from 73.6 million year over year. Product-related revenue, however, increased 16.8 percent to $13.2 million year over year and revenue from Perlegen Sciences more than doubled to $5.3 million, Affy said. Royalties and "other" revenue" increased 18.8 percent to $1.9 million year over year.

Total receipts for the period declined to $86.4 million from $88.6 million in the year-ago quarter.

R&D spending in the quarter surged 38.2 percent to $23.5 million from $17 million year over year.

Profits sank to $1.8 million, or $.03 per basic share, from $16.2 million, or $.26 per basic share, one year ago.

Affy said it had around $104.5 million in cash and equivalents and around $150 million in short-term securities as of March 31.

CombiMatrix Reports Meager Q1 Revenue Growth as CMD Group Drives R&D Spend; Losses More Than Double

CombiMatrix last week said that first-quarter revenue inched up 2 percent as R&D spending and net losses more than doubled.

Total receipts for the three months ended March 31 increased to $1.2 million from $1 million in the year-ago period.

Year over year, revenue from government contracts fell to $264,000 from $731,000; receipts from product sales surged to $924,000 from $278,000; while revenue from service contracts contracted by $30,000 to $57,000, CombiMatrix said.

The decrease in government contracts was due to completion of the company's $5.9 million biological threat detection contract with the Department of Defense in December 2005, the company said. CombiMatrix signed a new $2.1 million contract to develop its biological and chemical detector system in February of 2006, "resulting in lower contract costs in the first quarter of 2006 than in the comparable 2005 period."

"Our product and service revenue is increasing nicely, and this trend should continue as our products continue to gain acceptance with our customers," CombiMatrix President Amit Kumar said in the statement. "Additionally, the launch of products from our diagnostics division, earlier than originally planned, will augment our revenue growth.

"Our defense contracting revenue for the quarter was modest due to an unforeseen delay in initiation of our new government contract," Kumar said. "We expect this revenue to increase in the following quarters."

R&D spending in the period increased to $2.4 million from $1.1 million year over year. This increase was due "primarily" to developments ongoing at the CombiMatrix Molecular Diagnostics division.

The company said net losses increased to $7.7 million from $3 million in the year-ago period. The current quarter's loss included non-cash stock compensation, patent amortization and depreciation charges totaling $1.2 million versus $427,000 in the comparable 2005 period.

Geneservice Receives ISO Certification

The International Standards Organization has awarded Geneservice's facilities its ISO 9001:2000 certification for functional genomic products and the conduct of contract research for academic and commercial customers, the company said last week.

Geneservice is based in Cambridge, UK.

Filed under

The Scan

Drug Response Variants May Be Distinct in Somatic, Germline Samples

Based on variants from across 21 drug response genes, researchers in The Pharmacogenomics Journal suspect that tumor-only DNA sequences may miss drug response clues found in the germline.

Breast Cancer Risk Gene Candidates Found by Multi-Ancestry Low-Frequency Variant Analysis

Researchers narrowed in on new and known risk gene candidates with variant profiles for almost 83,500 individuals with breast cancer and 59,199 unaffected controls in Genome Medicine.

Health-Related Quality of Life Gets Boost After Microbiome-Based Treatment for Recurrent C. Diff

A secondary analysis of Phase 3 clinical trial data in JAMA Network Open suggests an investigational oral microbiome-based drug may lead to enhanced quality of life measures.

Study Follows Consequences of Early Confirmatory Trials for Accelerated Approval Indications

Time to traditional approval or withdrawal was shorter when confirmatory trials started prior to accelerated approval, though overall regulatory outcomes remained similar, a JAMA study finds.