Bruker Says 'Material Weakness' at Subsidiary
Will Force Firm to Raise 2004 Losses
A "material weakness in internal controls" at an undisclosed Bruker BioSciences subsidiary will cause Bruker to increase its 2004 net losses, the company said.
According to a statement released Wednesday, Bruker said it has been made aware of several 2004 audit adjustments that it said will have a negative impact on its 2004 financial results.
In addition, Bruker said German tax authorities revised their assessment after the company released its 2004 earnings on March 2. As a result, Bruker said it would ask the US Securities and Exchange Commission for a 15-day extension to its 2004 Form 10-K filing deadline.
"We had previously reported a GAAP net loss of $.06 per diluted share for the year ended December 31, 2004," William Knight, chief financial officer of Bruker. "Subject to some uncertainty, as we are still reviewing all quarters of 2004, we now expect that the combined effect of these audit adjustments and the higher tax assessment in Germany will increase our 2004 GAAP net loss to $.07 to $.09 per diluted share, with audit adjustments affecting several quarterly results during 2004.
"These adjustments should not have any affect on our 2005 goals and first-quarter 2005 guidance," the CFO added.
The company plans to schedule a conference call with investors to discuss the revised financial statements at the time of the 10K filing, Bruker said.
Sigma-Aldrich Allies With MIT's RNAi Group;
Will Help Develop, Distribute Reagents
Sigma-Aldrich has become a "scientific collaborator" and distribution partner to MIT's RNAi Consortium, bringing to four the number of corporate partners in the alliance, the company said this week.
The TRC's three-year goal is "to create a comprehensive library of RNA interference reagents designed to reduce expression of specific human and mouse genes, thereby enabling scientists to elucidate the function of the targeted gene," according to a statement.
To that end, Sigma-Aldrich will help the consortium develop and distribute clones, purified DNA, and viral stocks from the group's RNAi libraries to researchers worldwide, the company said.
Based at the Broad Institute, the consortium comprises seven research institutions, including Massachusetts General Hospital, Harvard Medical School, Dana-Farber Cancer Institute, The Broad Institute, Whitehead Institute for Biomedical Research, Massachusetts Institute of Technology, and Academia Sinica. It is also home to four companies, including Bristol-Myers Squibb, Eli Lilly, Novartis, and now Sigma.
Financial terms of Sigma's participation were not disclosed.
Manchester University Wins $11.5M Grant
To Open Systems Biology Center
The University of Manchester, UK, has won a £6 million ($11.5 million) government grant to open a new systems biology center, the school said this week.
The new facility, called the Manchester Center for Integrative Systems Biology, will use this money "to develop new methods of computational and mathematical analysis, validating these methods by testing them in yeast."
These methods will then be used to "create generic computational models with the potential to allow pharmaceutical companies to perform virtual trials of any medicine on any living organism," the university said.
The award was provided by The Biotechnology and Biological Sciences Research Council.
"Our aim is to develop the systems which will allow University scientists and pharmaceutical companies to understand how every gene in an organism works and reacts," said Douglas Kell, director of the new center. "This will provide them with the tools they need to develop safer and more effective medicines and will put Manchester on the map as one of the world centers for systems biology research."
It was not immediately clear when the new center will open.
NIEHS to Issue RFP for Protein Biomarker Discovery
The National Institute of Environmental Health Sciences later this month will solicit requests for proposals from labs that pursue protein biomarker discovery "in sub-cellular tissue fractions of target tissues or accessible biological fluids such as serum or plasma as a result of toxic insult or disease," according to the Institute.
The Institute also seeks "to achieve mechanistic insights as implicated or demonstrated by changes in proteins as a result of experimental treatments or in studying environmental models of disease."
The Institute has not disclosed the amount of money it has set aside for this RFP.
"[Applicants] are encouraged to propose a primary proteomic technology and be capable of using or acquiring additional proteomic platforms (possibly via subcontracts) and to demonstrate the offerors experience with and which substantiate utility of the approach for biological studies for protein expression, identification and characterization of various tissues and of one or more subproteomes," the NIEHS said.
One award is "anticipated" to be made on Jan. 31, 2006, which will cover a research period of two years with three one-year optional years," the NIEHS said.
The Institute expects to release the RFP on March 22, and proposals will be due May 5.
FDA Will Release PGX Guidance
March 18, Agency Officials Say
The US Food and Drug Administration will release its Guidance for Industry on Pharmacogenomic Data Submissions on Friday, March 18, according to two agency officials.
Larry Lesko, director of the office of clinical pharmacology and biopharmaceutics at the FDA's Center for Drug Evaluation and Research, announced the day during a presentation at a Drug Information Association conference in Lisbon, Portugal, last week. Lesko and Felix Frueh, CDER's associate director for genomics, both confirmed the date through an FDA spokesperson last Friday.
The long-awaited document will appear on a special website that the FDA will launch this week, Federico Goodsaid, an official at the agency's Office of Clinical Pharmacology and Biopharmaceutics, said during a lecture at the Society of Toxicology meeting in New Orleans last week.
During his presentation, Goodsaid said the FDA will release the final guidance "within a week or two."
The document, whose approval has been delayed numerous times since it was released as a draft in November 2003, may serve to encourage drug makers to use pharmacogenomics technologies in their drug-discovery efforts, and submit some of their findings as a way to help the FDA broaden its knowledge of the technologies.