Proteomic Tools Helped Drive 52-Percent Jump in R&D Success at Big Pharma; More Business Likely
Genomic and proteomic technologies have helped to significantly increase the number of drug candidates that enter clinical trials at the world's biggest pharmas, according to a report released last week from the Tufts Center for the Study of Drug Development.
After declining more than 20 percent from the mid-1990s to the early-2000s, the rate at which new drugs entered the clinic increased 52 percent between 1998-2002 and 2003-2005, the report found.
Though the study did not seek to learn why R&D productivity increased or to address technological tools that might have helped enable it, TCSDD Director Kenneth Kaitin said discussions he has with officials from big pharma indicate that genomic technologies and methodologies have played "an increasingly important role" in driving the improvement. These tools and methods include mass spectrometry, genome sequencing, gene-expression, high-content screening, and SNP-genotyping.
The report also showed that the overall percentage of drugs that reach the clinic and go on to win US Food and Drug Administration approval — 20 percent — hasn't changed much in 30 years. But most of these candidates began life in the clinic before genomic tools were widely used, and big pharma, emboldened by the way these tools lifted their overall R&D productivity, may decide that investing more in new technologies might lead to better data and improved odds with regulators for the next crop of drug candidates.
"I don't think there is any question [genomic tools are] playing an increasingly important role in candidate selection for products that enter clinical testing," Kaitin told ProteoMonitor sister publication BioCommerce Week. "Every company that I speak to now is saying that a significant improvement in their ability to select compounds for clinical development is access to these tools."
TCSDD reports carry enormous weight within the pharmaceutical industry. Its high-profile study on the cost of developing new drugs, which it conducts about every 10 years, most recently found that it costs more than $800 million and takes up to 15 years to bring a drug to market. These results, released in 2001, have become at once a rallying cry for pharmas eager to lower the regulatory cost burden and a defense for skyrocketing prescription costs.
That study has also played into the hands of genomic tool vendors that claim their technologies can lower the cost of drug discovery early in the game, at once saving millions in early-stage R&D funds while stacking the enrollment deck with patients genetically more likely to respond favorably. The new productivity study, therefore, might offer a hint of encouragement to entrenched tool vendors, especially instrument shops that have been buffeted by pharma's cyclical spending patterns.
Kaitin said drug company officials whom he interviews tell him genomic tools are becoming increasingly important to them. R&D heads at big pharma "are all talking about their increasing reliance on these platforms to make better determinations about which products to move forward," he said.
The complete version of this article, which includes tips for building better relationships with big pharma, appears in the current BioCommerce Week.
Agilent's Bio-Analytical Group Posts 8-Percent Revenue Growth; Sees Strong Demand for Genomics, Proteomics
Agilent Technologies this week reported 8-percent quarterly revenue growth for its Bio-Analytical Measurement segment amid an overall revenue increase of 12 percent.
For the company's second fiscal quarter ended April 30, orders in the BioAnalytical segment rose 4 percent to $401 million from $385 million in the same period of 2005.
Life sciences orders were up 4 percent, "with demand from traditional pharmaceutical customers down in the US, up modestly in Europe and up double digits in Asia compared to one year ago," the company said in a statement.
Demand for proteomics and genomics products was up more than 20 percent from last year, the company said.
Revenues for the Bio-Analytical segment increased 8 percent to $372 million from $344 million in the second quarter of 2005.
Agilent's total orders increased 21 percent to $1.59 billion from $1.32 billion, while total revenues rose 12 percent to $1.43 billion from $1.28 billion in the prior-year period.
The company's total R&D spending rose 4 percent to $197 million from $189 million in the comparable period of 2005.
Agilent's net income increased 21 percent to $115 million from $95 million.
The company held $2.7 billion in cash and cash equivalents as of April 30.
Beckman Coulter Delays Q1 Report as It Investigates Ex-Employee Allegations; Hires Forensic Accountants
Beckman Coulter will not file its 10-Q for the quarter ended March 31 on time while its board of directors examines a former employee's wrongful termination claims.
The employee, whom the company has not named, alleges in an April 17 letter that he was terminated for reporting "certain accounting and financial reporting issues" involving the obsolescence of about $25 million of inventory, accounting for returned equipment under lease, and disclosure of causes for change in expenses, the company said.
Beckman Coulter said its audit and finance committee has retained outside counsel and an outside forensic accounting firm to investigate.
NCI Awards Insightful $1.4M in Contracts to Develop Proteomic Software
Statistical software developer Insightful said this week that the National Cancer Institute has awarded it two Phase II contracts worth $1,394,027 to develop proteomics software.
Under the terms of the two-year contracts, Insightful will develop software for identifying protein biomarkers and will also develop a product called S+Proteome for processing and analyzing protein mass spectral data.
The awards follow on two preliminary software-development contracts worth $186,000 that NCI awarded Insightful in February.
S+Proteome will be built upon Insightful's S-Plus and S+ArrayAnalyzer software products.
As part of the phase II contracts, Insightful said it will also write a book on the analysis of mass spectra data using S-Plus and S+Proteome.
Locus Pharmaceuticals To Use Invitrogen's SelectScreen Platform
Invitrogen will provide Locus Pharmaceuticals with kinase screening services through its SelectScreen platform, Invitrogen said this week.
Invitrogen said that the platform will support Locus' discovery programs in the areas of cancer and inflammation.
Financial details of the transaction were not disclosed.
Invitrogen said that it has added 123 new human protein kinases to its SelectScreen screening panel over the last 14 months and that it will continue to expand the panel this year.
Biacore Opens Facility in China
Biacore International has opened its own operation in China that will conduct sales, marketing, and applications support and services, the company said last week.
The six-person operation will be headed by Peter Lee, former regional sales manager for GE Healthcare in Southern China.
Agilent, Nonlinear Dynamics Pen Co-marketing Deal Involving Bioanalyzer, Analysis Software
Nonlinear Dynamics and Agilent Technologies have signed a co-marketing agreement involving Agilent's 2100 bioanalyzer platform and Nonlinear's TL 120 CM software, the companies said last week.
Terms of the deal call for Nonlinear and Agilent to automate data exportation from Agilent's bioanalyzer for analysis, archiving, and data mining with Nonlinear's TL 120 DM software, the companies said.
Financial terms of the agreement were not disclosed.
Peakadilly to Use GeneGo's MetaCore in Proteomics Research
GeneGo said this week that protein biomarker discovery firm Peakadilly has licensed its MetaCore pathway analysis platform.
The content in MetaCore covers "multiple levels of protein interactions from extra cellular stimuli through signaling to core metabolism," making it suitable for proteomics research, GeneGo said.
Financial terms of the agreement were not disclosed.