ABI’s Mass Spec Tools to Play Role in BG, FDA Hepatotoxicity Biomarker Project
The US Food and Drug Administration has approved the first phase of a BG Medicine and National Center for Toxicological Research project to develop biomarkers for liver toxicity, BG Medicine said this week.
The company also said it will use mass spectrometry technology made by Applied Biosystems, and has named seven pharmaceutical companies that will participate in the project.
The goal of the project is to seek biomarkers of hepatotoxicity in humans in a standard preclinical pharmaceutical test.
BG Medicine said the project will be conducted under a Cooperative Research and Development Agreement and is part of the larger Critical Path Initiative, which the FDA inaugurated in 2004 as a response to what it called an “urgent need” to modernize and bring down the cost of medical products development.
BG Medicine said it expects phase one will last around nine months.
Pharmaceutical companies working with and helping to fund the biomarker project include Pfizer, Johnson & Johnson Pharmaceutical Research and Development, Mitsubishi Chemical Holdings, Orion, UCB, Sankyo, and Eisai.
BG Medicine submitted the CRADA with the FDA's NCTR in 2005. At the time, the company said that it had jointly designed the study with the FDA "with input from a number of pharmaceutical companies."
BG Medicine had said that the study will be funded by pharmaceutical manufacturers, who will receive "a paid-up perpetual license to any biomarkers discovered and access to all project data."
The study will be conducted at the FDA's NCTR laboratory in Jefferson, Ark., and at BG Medicine’s facility in Waltham, Mass., where the organizations will rely on a range of technologies, including functional genomics, proteomics, metabolomics, and computational analysis.
BG Medicine said it expects the project to result in improved tests for liver toxicity, which is the most common biological reason for drug failure.
Current toxicity testing methods "often fail to identify human liver toxicity issues," the company said. "Consequently, liver toxicity is often detected for the first time when drugs are in phase II of clinical testing after tens of millions of dollars or more have been spent on a drug."
Amid Reorganization, Invitrogen is 'Very Committed' to 'Promising' ProtoArrays
As Invitrogen continues its housecleaning, most recently saying that it would divest its BioReliance business, CEO Greg Lucier said last week that the firm’s ProtoArray protein chips would see continued investment.
“We are very committed to protein chips, and it is one [area] where unfortunately, tools just take a long time to mature and get adopted,” Lucier said during a conference call accompanying the firm’s fourth-quarter earnings release. “But we think it’s going to be a very promising, large opportunity as the year progresses and as we go into 2008.”
“We have a number of very close collaborations around the world with this chip on a number of different research processes,” he added. “We think that this is the year that these collaborations really bring to fruition the full power of the technology.”
The divestitures are the result of a major housecleaning Invitrogen has undergone for more than three months in the midst of free-falling losses (see BioCommerce Week 8/9/2006). Lucier first spoke of the need to stir things up last August when he said the company would “conduct a strategic review on each and every one of the businesses in which we operate … and if actions are needed, actions will be taken in order to make our portfolio one where we can … produce high margins in a very, stable consistent way.”
Most recently, Invitrogen said it was selling its BioReliance business unit to Avista Capital Partners for $210 million — a deep discount from the $500 million it paid for the business in 2004 (see BioCommerce Week 2/14/2007).
Illumina Closes Sale of $400M Senior Notes
Illumina said last week that it has closed the sale of $400 million in convertible senior notes.
The company had said earlier last week that it would sell $325 million in notes to pay for corporate expenses, but it raised the offering to $350 million a day later.
The sale at closing included the exercise of an over-allotment for an additional $50 million of notes, bringing the total to $400 million.
The sale will pay interest at .625 percent and will be due in 2014, at which time holders will receive cash value for the principal and common stock for any excess value.
Illumina said it plans to use $200 million from the sale to buy shares of its common stock in a private deal.
Beckman Coulter Declares Dividend
Beckman Coulter’s board of directors has declared a quarterly dividend payout of $.16 per share payable on March 16 to all stockholders of record on March 2, 2007.
It is the 71st consecutive quarterly dividend payout, Beckman said.
Eksigent Signs HPLC Distribution Pact for UK, Ireland
Eksigent said this week that it has signed a distribution agreement with Presearch that covers sales of Eksigent's NanoLC HPLC product line in the UK and Ireland.
Presearch is a distributor of HPLC, GC, flash chromatography, precision fluid delivery, and organoleptic sensors. The company has an installed base of several hundred customers, Eksigent said.