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Tarceva, Decode, Qiagen, DNAVision, Roche, Nanogen, SeqWright, VisiGen, ABI, Beckman Coulter, Consorta

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Tarceva Now Indicated in Combination as First-Line
Pancreatic Cancer Therapy; No Dx In New Indication

The US Food and Drug Administration said last week that it had approved Tarceva, a product of OSI Pharmaceuticals, Genentech, and Roche Pharmaceuticals as a first-line therapy for advanced pancreatic cancer, in combination with gemcitabine chemotherapy.

In Tarceva's new pancreatic cancer indication, no diagnostic recommended to identify responders, and research has not been conducted to show whether patients with EGFR up-regulation or EGFR mutations respond better to the combination therapy, an OSI spokesperson told Pharmacogenomics Reporter. A large majority of pancreatic tumors have an increased EGFR expression, which has been shown in some studies to correlate to better Tarceva response, the spokesperson said.

Tarceva, known by the generic name erlotinib, is currently indicated as a second-line treatment for non-small cell lung cancer, and was recently found to be broadly effective in promoting patient survival in that indication, without the use of diagnostics to identify responders. Previous research has suggested that the drug may be more effective in patients with increased EGFR expression.

Mutations in the EGFR gene do not appear to correlate to better Tarceva response. "Gene-copy number and protein expression still appear to be in the running, but our results were not definitive," Frances Shepherd, a medical oncologist at Princess Margaret Hospital and professor of medicine at the University of Toronto, told Pharmacogenomics Reporter in July. Shepard is the author of the study showing broad survival among NSCLC patients using Tarceva as a second-line treatment, and she co-wrote a study showing that diagnostics may be capable of identifying responders, both of which appear in the July 14 issue of the New England Journal of Medicine.

"Advanced pancreatic cancer and non-small cell lung cancer are two of the most difficult-to-treat cancers, and Tarceva, which targets the EGFR/HER1 pathway, has now been shown to increase survival in both these cancers," said Hal Barron, Genentech's senior vice president of development and the firm's chief medical officer in a statement last week. "We continue to study Tarceva in other cancers and in combination with other therapies."


Decode Reports 20-Percent Jump in Q3 Revenue,
Narrowed Losses; R&D Spend Surges 70 Percent

Decode Genetics this week reported a 20-percent increase in revenues amid narrowed losses for the third quarter.

Decode's revenues for the third quarter rose to $13.2 million from $11 million in the same period a year ago.

The company said R&D spending in the quarter surged nearly 70 percent to $11 million from $6.5 million for the same quarter last year.

Decode narrowed its net losses this quarter by 8.8 percent to $11.4 million, or $.21 per basic share, from $12.5 million, or $.23 per basic share in the year-ago period.

Decode had approximately $171 million in cash and cash investments as of Sept. 30.


Qiagen's Q3 Revenues Grow 7 Percent as Profit Spikes 40 Percent

Qiagen this week reported a 9-percent increase in sales and 40-percent spike in net profit in the third quarter.

Revenues for the three months ended Sept. 30 increased to $98.7 million from $90.4 million in the year-ago period. Qiagen said that unfavorable currency exchange rates cost the company $3.1 million in sales revenue. The company had provided guidance of $101.8 million in revenues earlier in the year.

Qiagen's net income for the third quarter jumped 40 percent to $17.6 million, or from $12.6 million in the third quarter last year.

"Reported revenues were slightly below the company's guidance ... as two of our OEM partners in molecular diagnostics further delayed certain product launches which include Qiagen instrument and consumable products," Roland Sackers, Qiagen's CFO, said in a statement.

Qiagen added that these delays led to a shortfall of approximately $2 million this quarter, primarily in instrumentation, which translated to a 14-percent drop in the growth of its instrumentation business. The company also said that there was a "good probability" that the delayed product launches will occur late this year or in early 2006.

The company's consumables business, which contributed about 89 percent to net sales, grew about 15 percent in the third quarter compared to Q3 last year.

Qiagen did not break out R&D expenses or its balance sheet.


European Lab DNAVision to Offer Services with
Roche's AmpliChip CYP450; First for Europe

DNAVision will provide Roche Diagnostics' AmpliChip CYP450 chip in its European service offerings, the companies said this week.

The Brussels, Belgium-based private testing laboratory is the first company to provide the AmpliChip in Europe, the companies said.

The US Food and Drug Administration cleared the AmpliChip CYP450 test for diagnostic use earlier this year and in the European Union in September 2004.


Nanogen's Revenues Nearly Double in Q3

Nanogen posted a near doubling of revenue in the third quarter, the company said last week.

Nanogen's total revenues for the period ended Sept. 30 increased 191 percent to $3.2 million from $1.1 million in the comparable quarter last year, the company said. Nanogen reported $1.1 million in product revenue for the third quarter of 2005, compared to $671,000 during the same period in 2004.

R&D spending in the period increased 26.7 percent to $5.7 million from $4.5 million year over year.

Nanogen's net loss fell to $8.8 million, or $0.18, from $9.4 million, or $.28 per share year over year.

The company had cash, equivalents, and short-term investments totaling $40.7 million at the end of the recent quarter.


SeqWright Makes Second Investment in VisiGen;
ABI Expected to Start Alliance Before End of Year

SeqWright has made a much-anticipated and undisclosed follow-on investment in Visigen Biotechnologies, meeting a key condition that would have kept Applied Biosystems from making its own investment in the next-generation sequencing company, SeqWright and VisiGen said last week.

As Pharmacogenomics Reporter's sister publication GenomeWeb News reported a year ago, SeqWright paid an undisclosed amount of cash for VisiGen stock to become a shareholder. The new investment helps clear the way for ABI to invest in and collaborate with VisiGen. The companies expect that VisiGen's collaboration with ABI will begin by the end of the calendar year.

VisiGen, based in Houston, is developing a real-time sequencing system to reduce the cost of DNA sequencing.


Beckman Coulter Licenses Clinical Lab Tests to
Consorta; Deals Worth $105M Over Five Years

Beckman Coulter will provide Consorta its chemistry, immunoassay, hematology, and automation product lines, the company said last week.

The three contracts are worth approximately $105 million over the next five years to Beckman. Consorta also extended its hematology agreement with Beckman, valued at $10 million a year, for two more years, Beckman said.

The contract provisions include the company's new line of UniCel systems, such as the DxC 600 and 800 chemistry analyzers, the DxI 800 Access immunoassay system, and the Power Processor automation system, said Robert Kleinert, an executive vice-president at Beckman Coulter, in a statement.

Consorta will also have access to nearly 200 different reagent kits.

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