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Sigma-Aldrich, Rosetta Genomics, NY State Department of Health, Parkway Clinical Laboratories, Silence Therapeutics, European Patent Office, Cenix BioScience, Alnylam Pharmaceuticals, Calando Pharmaceuticals, Regulus Therapeutics

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Sigma-Aldrich's Q2 Sales Climb 14.4 Percent
 
Sigma-Aldrich announced this week that its second-quarter revenues rose 14.4 percent, or 7.1 percent excluding the impact of currency translation.
 
The company brought in revenues of $580.7 million for the three-month period ended June 30 compared to revenues of $507.5 million for the second quarter of 2007.
 
The firm’s Research Essentials unit posted sales growth of 13.5 percent to $109.4 million; its Research Specialties unit had 16.8 percent revenue growth to $214.5 million; its Research Biotech unit posted sales growth of 17.6 percent to $86.4 million; and the SAFC unit had sales of $170.4 million, up 10.7 percent year over year.
 
Sigma-Aldrich’s net income for the second quarter was $90.8 million, or $0.70 per share, up 13.9 percent from last year’s second-quarter profit of $79.7 million, or $0.60 per share.
 
The firm’s R&D expenses increased 10.3 percent to $16 million from $14.5 million, and its SG&A costs rose 10.9 percent to $144.5 million from $130.3 million.
 
Sigma-Aldrich finished the quarter with $240.3 million in cash and cash equivalents.
 
The company is targeting full-year 2008 organic sales growth of 7 percent and earnings per share of between $2.62 and $2.72.
 

 
Rosetta miRNA-Based Lung Cancer Dx Approved by NY State
 
Rosetta Genomics said this week that the New York State Department of Health Clinical Laboratory Evaluation Program has approved the use of the firm’s microRNA-based test for differentiating squamous from non-squamous non-small cell lung cancer.
 
Rosetta said that the test classifies squamous-cell carcinoma of the lung with sensitivity of 96 percent and specificity of 90 percent. It is Rosetta’s first molecular test to be commercialized.
 
Rosetta President and CEO Amir Avniel said in a statement that the firm’s microRNA platform has enabled its partner, Columbia University Medical Center, “to develop a highly sensitive and specific test, which is a key for optimal administration of targeted therapies” for lung cancer.
Rosetta said that Columbia is currently "finalizing the commercial aspects" of the test and will announce its clinical availability "once details are finalized later this year."
 
The firm is developing two other microRNA-based tests, one for mesothelioma and one for cancer of unknown primary origin, which it expects to be validated and submitted for regulatory approval in the second half of this year. The tests are expected to reach the US market in 2009.
 
Rosetta also recently announced that it has moved three new microRNA-based tests: one for predicting response to ovarian cancer treatment, one for gauging the risk of gastric cancer recurrence, and one for differentiating small from non-small cell lung cancer (see RNAi News, 6/19/2008). These tests are expected to be commercialized in 2009 and 2010.
 

 
Silence to Receive European Patent on Lead Cancer Drug Candidate
 
Silence Therapeutics this week announced that the European Patent Office has said that it intends to issue a patent covering Silence’s lead product candidate, the gastrointestinal cancer drug Atu-027.
 
According to the company, the notice is based on European patent No. EP/03790894.4, which claims various aspects of the use of an siRNA to silence protein kinase N beta, the gene target of Atu-027, as well as the use of the gene for screening purposes and its use as a downstream target of the PI3-kinase pathway.
 

 
Cenix to Help Regulus Develop Targets for miRNA-Based Drugs
 
Cenix BioScience said this week that it has agreed to help Regulus Therapeutics, a joint venture between Alnylam Pharmaceuticals and Isis Pharmaceuticals (see RNAi News, 9/13/2007), develop its miRNA modulators for immunology and inflammation therapeutics. 
 
Under the research agreement, Cenix said it will use multi-parametric assays to screen Regulus’ libraries of synthetic miRNA modulators for novel molecules that could be used to develop new therapeutics. Specifically, Cenix said that it will apply its small RNA-based gene silencing technology with high-content phenotypic analyses in cultured human cells.
   
Financial terms of the agreement were not disclosed.
 

 
Rosetta Closes Acquisition of Parkway Clinical Laboratories
 
Rosetta Genomics announced this week that it has completed its $2.9 million acquisition of Clinical Laboratory Improvement Amendments-certified laboratory Parkway Clinical Laboratories.
 
Last month, Rosetta said it would buy Parkway in a bid to speed its introduction of microRNA-based diagnostics (see RNAi News, 6/12/2008).
 
Parkway’s “wide experience in diagnostic testing and regulatory compliance will provide us with strong commercial infrastructure that will complement our advanced [research and development] capabilities,” Rosetta President and CEO Amir Avniel said in a statement at the time.
 

 
Calando Licenses Alnylam IP for RNAi Cancer Drug
 
Alnylam Pharmaceuticals said this week that it has granted Arrowhead Research subsidiary Calando Pharmaceuticals a license to use its intellectual property to discover, develop, and market an siRNA against an undisclosed cancer target.
 
The non-exclusive license agreement also gives Alnylam the right of first negotiation to co-develop and co-commercialize the RNAi therapeutic product in the US.
 
Specific financial terms of the arrangement were not disclosed, but Alnylam said it will receive upfront and milestone payments, as well as royalties on sales of any products covered by the licensing agreement.

The Scan

Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.

Duke University Team Develops Programmable RNA Tool for Cell Editing

Researchers have developed an RNA-based editing tool that can target specific cells, as they describe in Nature.

Novel Gene Editing Approach for Treating Cystic Fibrosis

Researchers in Science Advances report on their development of a non-nuclease-based gene editing approach they hope to apply to treat cystic fibrosis.

Study Tracks Responses in Patients Pursuing Polygenic Risk Score Profiling

Using interviews, researchers in the European Journal of Human Genetics qualitatively assess individuals' motivations for, and experiences with, direct-to-consumer polygenic risk score testing.