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Roche Diagnostics, Epistem, AstraZeneca, Cell Signaling Technology, Bristol-Myers Squibb, White House, Department of Health and Human Services, NIH, FDA, CDC, DNAPrint Genomics, Nanobac Pharmaceuticals, CombiMatrix, Clarient

Roche Diagnostics' Q4 Revenues Rise 8.4 Percent; MDx Sales Dip in 2007
Roche reported last week that its diagnostics division had fourth-quarter 2007 revenues of 2.5 billion Swiss francs ($2.3 billion), an 8.4 percent gain on revenues of CHF 2.3 billion in the fourth quarter of 2006.
For full-year 2007, Roche Diagnostics’ sales increased 7 percent to CHF 9.35 billion from CHF 8.75 billion in 2006. The firm said its share of the entire global diagnostics market is around 19 percent, which would make it the top player in the industry.
Roche reported strong growth for its Professional Diagnostics and Applied Science businesses, while sales of its molecular diagnostics products slipped 2 percent to CHF 1.15 billion for the year.
“As expected, pressure on industrial reagent prices continued to affect Roche Molecular Diagnostics’ sales,” the firm said in a statement. It added that excluding industrial reagent sales, its molecular diagnostics revenues were up 3 percent for 2007.
During 2007, Roche introduced in Japan tests for HIV-1, hepatitis B, and Hepatitis C virus to run on the Cobas AmpliPrep/Cobas TaqMan platform. It also launched the HIV-1 test in the US, and as of the end of the year had 122 supply contracts for the test with US labs including a deal with Laboratory Corporation of America.
In addition, Roche has several molecular diagnostic tests awaiting US Food and Drug Administration clearance, which should contribute to growing the segment in the future.
The company expects that its Amplicor HPV test will be the second FDA-cleared molecular diagnostic test for human papillomavirus. If approved, it would join Qiagen’s HPV molecular diagnostic test already on the US market. Roche also has a genotyping HPV test awaiting FDA clearance, as well as a molecular test for hepatitis C and a multiplex test for HIV/HCV/HBV.
Sales for the Applied Science business rose 11 percent year over year to CHF 692 million. That business has been boosted by the acquisitions over the past year of 454 Life Sciences, BioVeris, and NimbleGen Systems. Roche said the key growth drivers in Applied Science were its LightCycler 480 instrument; the Genome Sequencer FLX, which it gained through the purchase of 454 and launched in the first half of 2007; and research reagents.
Roche Diagnostics reported an operating profit of CHF 1.6 billion for 2007, up 14 percent for the year.
Roche recently signed an agreement to acquire Ventana Medical Systems for roughly $3.4 billion.
“This acquisition will enable us to move into the fast-growing market for tissue-based diagnostics and strengthen our capabilities for developing companion diagnostic tests,” Roche Chairman and CEO Franz Humer said during a conference call last week. “Ventana is a significant milestone in our efforts to develop personalized healthcare solutions, including more cost-efficient, differentiated and targeted medicines.”
Overall, the Roche Group’s fourth-quarter sales rose 4 percent to CHF 12.2 billion from CHF 11.7 billion. For the full year, its revenues climbed 10 percent to CHF 46.1 billion from CHF 42 billion. Its net income for the year rose 25 percent to CHF 11.4 billion from CHF 9.2 billion.
Roche’s R&D expenses rose 14 percent in 2007 to CHF 8.4 billion from CHF 7.4 billion.
The firm’s Pharmaceuticals Division posted 2007 revenue growth of 10 percent to CHF 36.8 billion from 33.3 billion.
Roche officials forecast 2008 revenue growth in the high single digits.

Epistem Hoping to Apply 'Plucked Hair' Biomarker Approach to Cancer Drug Studies
British biotech firm Epistem has completed a preliminary study of its plucked hair biomarker technology with AstraZeneca, the company announced this week.
The minimally invasive hair biomarker system makes it possible to retrieve RNA from the base of a single plucked human hair, facilitating gene expression measurements.
Results from the current study suggest the plucked-hair method is well tolerated by patients and provides reliable results. The researchers were able to evaluate RNA representing over 13,000 genes from more than 85 percent of the single hairs. The results were presented at a recent AACR-NCI-EORTC meeting in San Francisco.
By comparing the gene sets linked to tumors as well as drug exposure and toxicity, the companies hope to eventually use the hair biomarker approach to evaluate the effectiveness of new cancer treatments.
“Our published results clearly demonstrate that the method is both feasible and practical, and offers the promise of providing insights into both dose and patient selection,” Andrew Hughes, an AstraZeneca scientist, said in a statement.

Bristol-Myers to Use Cell Signaling Technology's PhosphoScan in Drug Study
Cell Signaling Technology this week said that Bristol-Myers Squibb will use its PhosphoScan technology in cell and tumor phospho-profiling of a small molecule kinase inhibitor.
The PhosphoScan process involves immunoaffinity purification and tandem mass spectrometry. It will be applied to in vivo phosphorylation profiling of kinase inhibitor response profiles in xenograft tumor models.
Danvers, Mass.-based CST said that the signatures generated with the Bristol-Myers compound will be analyzed within the context of its PhosphoSignature database, which covers hundreds of cell lines and human tumors.
The firms signed this agreement following an evaluation period for the technology, which ended in March 2007.
Terms of the alliance were not disclosed.

Bush's Proposed 2009 Budget Stalls Biomedical Research Funds
US President George W. Bush this week proposed a budget for fiscal year 2009 that would hold biomedical research spending at 2008 levels, and would, when adjusted for inflation, trim budgets for federal medical research.
The $737 billion budget for the Department of Health and Human Services, which includes federal funding for genomics, genetics, imaging, computational biology, and pharmacogenomics research, maintained a flat budget for the National Institutes of Health, recommended small increases at the US Food and Drug Administration, and requested slightly less funds for the Centers for Disease Control and Prevention.
These budgetary requests do not cover increased costs due to biomedical inflation. Last year, the NIH projected costs due to inflation to increase by around 3.7 percent.
The President budgeted $5.7 billion for the CDC, a dip of $433 million from $6.1 billion last year. For the FDA, the president asked for $2.4 billion total program level spending, compared with $2.27 billion in 2008.
Under the White House’s proposed budget, the NIH would receive $29.47 billion in FY 2009, the exact amount it was authorized for FY 2008. The budget allots $488 million for the National Human Genome Research Institute, compared with $487 million in 2008. The National Cancer Institute would receive $4.81 billion in 2009, compared with $4.805 billion this year.
The NIH stated recently it is taking policy measures to adjust for flat funding.
In a press conference this week HHS Secretary Mike Leavitt delivered the White House’s budget proposals as “a warning” that spending on entitlement programs such as Medicare must be reined in, and efforts to trim costs clearly spilled over into the proposals for biomedical research spending.
In the budget, the White House highlighted the importance of biomedical research, stating that “recent advances in genomics, proteomics, computational biology, and many other fields of science” are giving researchers tools that will allow them a broader understanding of disease “years before it strikes the patient.”
According to the White House, these fields of research are the “cornerstone for efforts to transform the practice of medicine from one in which intervention is often indiscriminate and too late in the disease process, to one that will be personalized, predictive, and pre-emptive, with greater patient and community participation in the active management of their health.”

Nanobac to Buy DNAPrint Genomics
DNAPrint Genomics has inked an agreement to be acquired by Nanobac Pharmaceuticals, a maker of diagnostics and prescription nanobiotic medications, for an undisclosed sum, Tampa, Fla.-based Nanobac said last week. 
DNAPrint Genomics, which trades on NASDAQ’s Over-the-Counter Bulletin Board, has a market capitalization of around $2.26 million, and in 2006 had annual revenue of around $2.4 million while taking a loss of around $12.5 million. The proposed acquisition is subject to the approval of DNAPrint Genomics’ shareholders.
Nanobac said it expects the combined company would have annualized revenues of around $5 million.
DNAPrint markets DNAWitness, a genome analysis forensics suite used to determine heritage from crime-scene DNA, and a genealogy product. It also is developing diagnostic tests and treatments, including tests for ovarian cancer, statin safety, complications related to diabetes, and an anemia drug that is an alternative to a therapy produced by Amgen.
Combining Nanobac’s NB2 diagnostic with DNAP’s Protectin test for vascular risk of diabetic patients could “play a significant role in the early diagnostics of vascular disease and could potentially help in identifying early signs and progression of cardiovascular disease,” said Nanobac Co-chairman and Chief Medical Officer Benedict Maniscalco.

CombiMatrix, Clarient Partner on CLL Test
CombiMatrix announced last week that it will collaborate with Clarient to market and sell CombiMatrix’s HemeScan, a prognostic and diagnostic monitoring tool for chronic lymphocytic leukemia.
The test was developed by CombiMatrix in collaboration with researchers at the MD Anderson Cancer Center in Houston, the University of Texas Health Sciences Center in San Antonio, and the Netherlands Cancer Institute in Amsterdam.
Under the agreement, cancer diagnostics services lab Clarient will market the tests to pathologists, oncologists, and patients.
According to CombiMatrx, the test provides prognostic marker precision with simultaneous diagnostic monitoring of the entire genome in CLL. The firm said that the test also has been validated for acute lymphoblastic leukemia and myelodysplastic syndrome, and it is currently being tested for multiple myeloma.
CombiMatrix said there are more than 10,000 new cases of CLL annually in the US and over 150,000 patients living with the disease.

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